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Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial
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J Tradit Chin Med 2016 February 15; 36(1): 19-25 ISSN 0255-2922 © 2016 JTCM. All rights reserved.
CLINICAL STUDY TOPIC
Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial
Lin Ruizhu, Zhu Ning, Liu Jian, Li Xinjian, Wang Yue, Zhang Jie, Xi Chaolei aa Lin Ruizhu, Zhu Ning, Liu Jian, Wang Yue, Zhang Jie, Xi Chaolei, Department of Rehabilitation Medicine, General Hospital of Ningxia Medical University, Yinchuan 750004, China Li Xinjian, Medical School of Acupuncture, Fujian University of Traditional Chinese Medicine, Fuzhou 350108, China Supported by Study the mechanism based on the p38MAPK signal pathway mediated by Cautery moxibustion therapy of Hui medicine treatment IDD (The National Natural Science Foundation of China, No. 81360567); Evaluation of different moxibustion doses for low back pain: a randomized controlled clinical trial of moxibustion therapy on CV4 (Ningxia Natural Science Foundation, No. NZ11208) Correspondence to: Prof. Xu Jianfeng, Department of Orthopedics and Traumatology, General Hospital of Ningxia Medical University, Yinchuan 750004, China. [email protected]; Prof. Wu Yongli, Department of Orthopedics and Traumatology, General Hospital of Ningxia Medical University, Yinchuan 750004, China. Wuyongli999@163. com Telephone: +86-951-6743730 Accepted: March 18, 2015
therapy (PT) group. Patients in the AM group were treated with acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture. Patients in the SAM group were treated with sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture. Conventional acupuncture was performed in the CA group, and physical therapy was applied in the PT group. Each treatment lasted for 20 min. Patients were assessed before and after treatment using a visual analogue scale (VAS) and the Roland Morris Questionnaire (RMQ). RESULTS: The VAS and RMQ scores in the AM group were significantly lower after than before treatment (P < 0.01). The AM group reported lower RMQ scores in after-treatment and 24 h after treatment and lower VAS score in 24 h after treatment in comparison with those of the CA, SAM, and PT groups (P < 0.05). CONCULSION: Acupuncture-movement therapy is effective for treating acute lumbar sprain with a persistent pain-relief and remarkable improvement of lumbar activity. Movement, that is, lumbar exercise during acupuncture, enhances the effect of acupuncture.
Abstract OBJECTIVE: Several studies have reported that acupuncture is effective for treatment of acute lumbar sprain, but they neglected to consider that acupuncture cannot remarkably improve lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy versus conventional acupuncture in the treatment of acute lumbar sprain.
© 2016 JTCM. Open access under CC BY-NC-ND license. Key words: Acupuncture; Movement; Exercise; Lumbar sprain; Randomized controlled trial
METHODS: Sixty patients were randomized into four groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical JTCM | www. journaltcm. com
INTRODUCTION Acute lumbar sprain refers to an acute injury of the lumbar muscles, fasciae, ligaments, or intervertebral 19
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facet joints caused by overburden, improper posture and movement, or insufficient preparation before exercise.1 It leads to severe lower back pain and limitation of spinal activities. Statistics show that acute lumbar sprain affects 60% to 80% of the general adult population, especially young adults and manual workers.2 This common health problem greatly decreases patients' quality of life.3 Nonsteroidal anti-inflammatory drugs and physical therapy are commonly used to treat acute lumbar sprain, but some drugs should be avoided because of their various side effects.4 Affected patients often seek help through complementary therapy. Acupuncture is usually adopted for treatment in such cases. The ability of acupuncture to effectively relieve pain has been confirmed by a considerable amount of research to date.5 Unfortunately, the long-term effects of acupuncture in relieving pain and improving lumbar activity are relatively poor. However, acupuncture-movement therapy solves this problem in many cases.6 Acupuncture-movement therapy is a new treatment technique for some locomotor and nervous system diseases. Acupuncture and movement promote and influence each other in the course of treatment. The doctor usually punctures acupoints distal to the lumbar region, and the patient is asked to exercise his or her waist while retaining the needles.7 The immediate analgesic effect of the acupuncture lays the foundation for lumbar exercise, while the exercise enhances the long-term effect of the acupuncture in relieving pain and improving lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy for treatment of acute lumbar sprain.
Ethics Committee of the General Hospital of Ningxia Medical University. Patients Patients received information about the study from newspapers and posters at the General Hospital of Ningxia Medical University and from the Internet in their communities. The treatment process was explained to each patient to ensure an understanding of the study. After signing a consent form, the patients were enrolled in the trial. The criteria for diagnosis and therapeutic effects for Traditional Chinese Medicine (TCM) diseases and syndromes issued by the State Administration of TCM were adopted for treatment and evaluation in this trial.8 Inclusion criteria The inclusion criteria were as follows: age of 20 to 60 years, ≤ 3-day course of acute lumbar sprain, visual analog scale (VAS) score of ≥ 4 (moderate to severe pain), no spinal surgery, no acupuncture treatment for acute lumbar sprain in the previous month, and no treatment since the onset of the acute lumbar sprain. Exclusion criteria The exclusion criteria were as follows: infectious diseases, tuberculosis, and rheumatic diseases; other serious diseases such as mental disorders, cancer, stroke, and myocardial infarction as well as cardiac pacemaker implantation; radicular pain indicative of nerve root compression; diagnosis of severe spinal canal stenosis, spondylolisthesis, or fibromyalgia; pregnancy; and physical or laboratory examination findings indicative of unsuitability for our study. Patients were instructed to undergo acupuncture and physical therapy for pain control. The use of nonsteroidal anti-inflammatory drugs and other therapies were monitored and recorded by the researchers, and these patients were analyzed separately.
METHODS Study design This randomized, single-assessor-blinded clinical trial was carried out in the General Hospital of Ningxia Medical University in China from May 2012 to January 2014. In total, 60 patients were observed. A computer-generated random number table was used. The 60 patients were randomized into 4 groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical therapy (PT) group. The trial statistician, who was not involved in the treatment administration or outcome collection, generated the schedule for the random allocation sequence, which was held in a secure cabinet only accessible to himself. To investigate whether the treatment preference had any influence on outcomes, each patient was asked which treatment he or she would prefer to receive before randomization. Due to the nature of the interventions, it was not possible to blind the doctor who provided the treatments. This study was approved by the JTCM | www. journaltcm. com
Interventions Acupuncture therapy and sham acupuncture therapy Acupuncture and sham acupuncture were carried out by certified acupuncture doctors with ≥ 5 years of clinical experience in the General Hospital of Ningxia Medical University. Yintang (EX-HN 3) was selected for treatment in the AM、CA and SAM groups. In the AM and CA group, the acupuncture point was routinely disinfected and a disposable stainless steel needle (0.30 × 25 mm; Huatuo Acupuncture, Suzhou, China) was inserted horizontally. The needle was retained for 20 min after arrival of Qi and then removed. In the SAM group, the acupuncture point was routinely disinfected and pressed with a semi-blunt needle fitted within a guide tube. The tube containing the needle was fixed onto the forehead with adhesive plaster. After 20 min, the tube and needle were removed. 20
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ment were also obtained from the patients via telephone and recorded by the researchers. The secondary outcome in this trial was motion limitation caused by the lumbar sprain. The motion limitation was assessed by the RMQ (range, 0-24 points, with 24 indicating the most severe limitation). The RMQ comprises 24 questions, and each has two possible responses.10 The RMQ scores were assessed before treatment, immediately after treatment, and 24 h after treatment.
Exercise The doctor prescribed the exercise program (lumbar flexion, stretching, and rotation) according to the condition of each individual patient. After the needle had been inserted in Yintang (EX-HN 3), the patient was asked to stand up. The doctor stood behind the patient with two hands supporting the patient's low back and asked him or her to exercise the lumbar region from small to large amplitude and from slow to fast speed, within the limit of his or her endurance. When the patient felt the lumbar muscles relax enough for active movement, he or she was encouraged to perform bending, stretching, and rotating exercises. The lumbar exercises lasted for 20 min until the acupuncture or sham acupuncture therapy was finished.
Safety monitoring The vital signs of each patient were checked before treatment. During treatment, the condition of each patient was carefully observed. Nausea, vomiting, fatigue, dizziness, pallor, hematoma, and any other adverse events related to acupuncture were recorded in detail.
Physical therapy Transcutaneous electrical nerve stimulation (TENS) was carried out by a certified physical therapist with ≥ 5 years' clinical experience in the General Hospital of Ningxia Medical University. The patients in the PT group were asked to lie on the treatment bed in a comfortable prone position. The treatment room was kept quiet and the temperature controlled at 25 ℃ to 29 ℃. A six-channel portable TENS instrument (model TS-6000; DANMETER A/S, Denmark) was used for treatment (medium-frequency sinusoidal waves, TENS form, 30-Ma intensity, and 50-µs pulse length) with 10- × 5-cm surface disposable electrodes placed on the painful spot of the lumbar region. All patients received treatment at the same time. Immediately after and 24 h after treatment, the patients were asked to perform self-assessments with the VAS and Roland Morris Questionnaire (RMQ).
Statistical analysis The data were analyzed with the Statistical Package for Social Sciences software (version 16.0; SPSS, Inc., Chicago, IL, USA). A P value of < 0.05 was deemed statistically significant. The measurement data were expressed as mean±standard deviation ( xˉ ± s). The VAS and RMQ scores were assessed by analysis of variance as between-group factors, and the three evaluations (before treatment, immediately after treatment, and 24 h after treatment) were assessed as within-group factors. The χ2 test or Wilcoxon test was used for categorical variables.
RESULTS A total of 71 patients with acute lumbar sprain passed the outpatient screening. Eleven patients were excluded either because they did not consent to the study or because they had been previously treated by acupuncture and moxibustion. Sixty patients who met the inclusion criteria were randomized into four groups. The 60 patients comprised 39 men and 21 women aged 22 to 58 years. The baseline age, sex, duration of acute lumbar sprain, VAS scores, and RMQ scores are shown in Table 1. No significant differences were noted among the
Evaluation The primary outcome in this trial was pain intensity. Before the treatment, the patients were instructed to adopt the posture that produced the most severe pain and to indicate this severity of pain on the VAS. The researchers recorded the VAS scores and postures of the patients. After treatment, the patients were asked to determine their VAS score while adopting the most painful posture as before.9 The VAS scores 24 h after treat-
Table 1 Comparison of age, sex, duration of disease, VAS score, and RMQ score in the four groups ( xˉ ± s) Items
AM group
SAM group
CA group
PT group
Age (years)
34.7±4.6
36.2±3.2
36.0±4.9
33.9±5.2
Male [n (%)]
9 (62.48)
10 (71.42)
9 (69.23)
8 (61.53)
Female [n (%)]
5 (37.52)
4 (28.58)
4 (30.77)
5 (38.47)
Duration (h)
25.7±5.7
27.8±4.3
27.2±5.2
24.8±6.8
VAS (scores)
74.9±9.8
69.3±10.5
72.6±11.5
69.0±12.6
RMQ (scores)
15.4±3.4
15.8±3.2
13.4±2.2
14.5±2.6
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement [sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min]; CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy (transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire. JTCM | www. journaltcm. com
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four groups. The mean baseline VAS score was 72.0 ± 5.7, indicating that our study included patients with moderate and severe pain intensity associated with acute lumbar sprain. Two patients in the PT group, one patient in the SAM group, and one patient in the CA group dropped out because they underwent additional treatments that were prohibited in our trial. One patient in the AM group dropped out because she fainted during the acupuncture treatment. One patient in the CA group dropped out because of deterioration of symptoms. The total dropout rate was 10%, and there was no statistical difference in the dropout rates among the four groups. The statistical analyses were carried out on the 54 patients who finished the whole trial and provided all required information (Figure 1).
Adverse events One patient in the AM group fainted during the acupuncture treatment and spontaneously recovered after a short rest with no special treatment. No adverse reactions occurred in the other groups. Adverse events were monitored and recorded by the researchers at every visit. Pain intensity scores (VAS) Changes in the VAS scores after the treatment are shown in Table 2. In the within-group comparison, the mean VAS score in each of the four groups decreased immediately after and 24 h after treatment (P < 0.01). In the AM group, the VAS score was 75 ± 10 before treatment, 29 ± 4 immediately after treatment, and 15 ± 3 24 h after treatment (P < 0.01).
Included sample with acute lumbar sprain (n = 60)
Ramdomized
Acupuncture movement group (start) (n = 15)
SHAM acupuncture movement group (start) (n = 15)
(CA) Conventional acupuncture group (start) (n = 15)
Post-treatment (n = 15)
Post-treatment (n = 15)
Post-treatment (n = 15)
1 drop out (additional treatments)
1dropout (fainted) 24 h after treatment (n = 14)
24 h after treatment (n = 14)
Transcutaneouselectrical nerve stimulation (start) (n = 15)
Post-treatment (n = 15) 2 drop out (additional treatments)
2 drop out (additional treatment, deterioration of symptoms) 24 h after treatment (n = 13)
24 h after treatment (n = 14)
Figure 1 Flow chart of the patients Table 2 Comparison of VAS scores in the four groups (scores, xˉ ± s) Group
n
Before treatment
After-treatment
24 h after treatment
AM
14
75±10
29±4
15±3a
SAM
14
69±11
42±5a
32±6acd
CA
13
73±11
31±6 ab
25±4ac
PT
13
69±13
32±7ab
31±8acd
ab
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement [sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min]; CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy(transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire; In the within-group comparison, the VAS scores before treatment were compared with those immediately after and 24 h after treatment in the four groups, aP < 0.01. In the between-group comparison, the VAS scores after treatment were compared in the AM, CA, and PT groups vs the SAM group, bP < 0.05; those 24 h after treatment were compared in the SAM, CA, and PT groups vs the AM group, cP < 0.05; and those 24 h after treatment were compared in the SAM and PT groups vs the CA group, dP < 0.05. JTCM | www. journaltcm. com
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Lin RZ et al. / Clinical Study Table 3 Comparison of RMQ scores in the four groups (scores, xˉ ± s) Group
n
before treatment
after-treatment
24 h after treatment
AM
14
15.4±3.4
6.7±1.8a
4.2±1.0a
SAM
14
15.8±3.2
10.3±2.5bc
7.8±1.4ad
CA
13
13.4±2.2
10.8±3.2bc
6.6±1.6ad
PT
13
14.5±2.6
11.3±2.7bc
7.2±2.2ad
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement(sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min); CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy (transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire; In the within-group comparison, the RMQ scores immediately after and 24 h after treatment were compared with those before treatment in the four groups, aP < 0.01 and bP < 0.05. In the between-group comparison, the RMQ scores after treatment were compared in the SAM, CA, and PT groups vs the AM group, c P < 0.05; and those 24 h after treatment were compared in the SAM, CA, and PT groups vs the AM group, dP < 0.05.
In the between-group comparison, the VAS score immediately after treatment in the SAM group was higher than those in the other groups (P < 0.05). At 24 h after treatment, the VAS score in the AM group was lower than those in the other groups (P < 0.05), while that in the CA group was higher than those in the SAM and PT groups (P < 0.05).
Acupuncture-movement therapy is a new treatment method for some locomotor diseases and nervous system diseases. The effects of acupuncture and movement promote each other. Doctors usually puncture distal points and retain the needles while the patient performs active movement or passive activity to exercise the affected part.11 Many clinical studies and meta-analyses have confirmed the effects of acupuncture and exercise for some diseases. Patients first receive acupuncture treatment and then begin to exercise the affected part until the acupuncture treatment is finished.12,13 This acupuncture plus exercise therapy is a superposition of two methods;14 it maximizes the synergy of the two, obtaining a better effect. In TCM, the main function of the meridians and collaterals is to transport Qi and blood. When Qi, blood, Yin, and Yang are not in balance, the meridian Qi will be stagnated or in disorder, leading to disease. Acupuncture can regulate the circulation of the meridian Qi and blood. Exercise is helpful for the flow of Qi and blood and for strengthened body resistance. Active movement or passive activity can also promote the flow of Qi and blood, enhancing the function of acupuncture treatment by conducting the needling sensation to the affected part.15 Huang Di Nei Jing states that "Arrival of Qi produces the effect." The analgesic effect of acupuncture, especially the immediate effect, is widely recognized.16 Exercise therapy helps to improve its long-term pain-suppressing effect.17 Acupuncture therapy mainly acts on the sensory system, while exercise is related to the motor system. There is a close interrelationship and interaction between the sensory and motor systems. Acupuncture-movement therapy has been successfully used in medical practice because of the very important effect of movement in controlling sensory affernets.18 Additionally, movement activates the central pain-inhibiting system, which gives out descending impulses to potentiate descending inhibition.19,20 The pain threshold is increased by acupuncture treatment, and the pain is then immediately relieved, laying the foundation for movement of the affected body part. Active or passive movement enhances the
RMQ scores Changes in the RMQ scores after the treatment are shown in Table 3. The RMQ scores in the four groups decreased immediately after and 24 h after treatment. In the AM group, the RMQ scores before treatment were lower than those immediately after and 24 h after treatment (P < 0.01). The RMQ scores before treatment in the SAM, CA, and PT groups were lower than those immediately after treatment (P < 0.05). There was a significant difference in the RMQ scores immediately before and 24 h after treatment in the SAM, CA, and PT groups (P < 0.01). In the between-group comparison, the RMQ scores immediately after and 24 h after treatment in the AM group were lower than those in the SAM, CA, and PT groups (P < 0.05). However, there was no significant difference in the RMQ scores immediately after and 24 h after treatment in the CA, SAM, and PT groups (P > 0.05).
DISCUSSION In the present study, a significant reduction in the VAS and RMQ scores in the AM group was observed immediately after and 24 h after treatment. At 24 h after treatment, the VAS score in the AM group was lower than those in the SAM, CA, and PT groups. Immediately after and 24 h after treatment, the RMQ score in the AM group was lower than those in the SAM, CA, and PT groups. These results indicate that acupuncture-movement therapy can immediately improve lumbar activity and has a good long-term analgesic effect. It was more effective than sham acupuncture-movement, conventional acupuncture, and physical therapy for acute lumbar sprain in this study. JTCM | www. journaltcm. com
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long-term pain-suppressing effect because the nerve impulse of movement and sensory are integrated at all levels of the peripheral and central nervous systems in acupuncture treatment. Active or passive movement can also re-establish normal motor patterns in the central nervous system, turning the abnormal activity model into a normal activity model. The affected body part is then able to maintain bio-mechanical stability, and a long-term pain-suppressing effect is obtained.21 In TCM, acute lumbar sprain is characterized by low back and leg pain caused by a sudden force that damages the Governing Vessel and Bladder Meridian, resulting in stagnation of Qi and blood in the lumbar region.22 Acupuncture-movement therapy is very effective in the early stage (the first 3 days) because the main problem in this stage is Qi stagnation. After 3 days, the damage extends into the blood system, and bloodletting therapy should be performed. In our study, Yintang (EX-HN3) was selected to regulate the flow of Qi for dredging the Governing Vessel. It is an extraordinary point located on the Governing Vessel, which is the sea of Yang meridians and functions to govern Yang and Qi. Exercising the lumbar region during acupuncture is helpful for promoting the flow of Qi of the Governing Vessel and Bladder Meridian.23 Thus, acupuncture-movement therapy can immediately improve the lumbar activity and has a good long-term analgesic effect. The RMQ score in the AM group immediately after and 24 h after treatment was lower than those in the SAM, CA, and PT groups. This shows that acupuncture-movement therapy can improve lumbar activity because of the re-establishment of normal motor patterns, which in turn allows the lumbar vertebrae to maintain stability and provides immediate pain relief. The VAS scores were reduced in the four groups immediately after treatment, although the VAS score in the SAM group immediately after treatment was higher than those in the AM, CA, and PT groups. This means that acupuncture increases the pain threshold; thus, the pain is temporarily relieved. Sham acupuncture does not have a good analgesic effect. At 24 h after treatment, the VAS score in the AM group was lower than those in the SAM, CA, and PT groups. The present study indicates that active movement is a decisive factor resulting in a good long-term analgesic effect. Exercising the lumbar region turns the abnormal activity model into a normal activity model of the lumbar muscles. This allows the lumbar vertebrae to maintain stability. Exercise is also an important factor in obtaining a good long-term analgesic effect.24 Exercise during acupuncture is helpful for promoting the flow of Qi and thus removing obstruction of the Governor Vessel. Huang Di Nei Jing stated, "Pain is caused by obstruction of meridians. Pain disappears when the meridians are unobstructed." The present study has several limitations, such as the small sample size, finite treatment time, and insuffiJTCM | www. journaltcm. com
cient blinding of the patients and assessor. Further studies with larger sample sizes and adequate blinding are needed. If the course of acute lumbar sprain is > 3 days, Qi stagnation may cause blood stasis. This is why TCM holds that "Normal flow of Qi ensures normal circulation of blood, while stagnation of Qi leads to blood stasis." Bloodletting therapy should be adopted for treatment of blood stasis; this will be discussed in a future study. Only patients with acute lumbar sprain of a ≤ 3-day duration were enrolled in the present study. Acupuncture-movement therapy provides a synergistic effect of acupuncture and movement with a stronger stimulation. Because one patient in this study fainted, however, doctors should carefully observe the patient's condition during treatment. Acupuncture-movement therapy is effective for acute lumbar sprain. Lumbar exercise during acupuncture enhances the effect of acupuncture by providing persistent pain relief and remarkable improvement of lumbar activity.
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Yao XJ, Liu JW. Observation on clinical efficacy of acute pain treated with the intervention of different time of needle retention. Zhong Guo Zhen Jiu 2013; 33 (11): 985-988. Inoue M, Kitakoji H, Ishizaki N, et al. Relief of low back pain immediately after acupuncture treatment-a randomized, placebo controlled trial. Acupunct Med 2006; 24(3): 103-108. Vas J, Aranda JM, Modesto M, et al. Acupuncture in patients with acute low back pain: a multicentre randomized controlled clinical trial. Pain 2012; 153(9): 1883-1889. Niu M, Xue MX, Zhang SN. Elongated needle with passive flexion of the hip and knee for 40 cases of acute lumbar sprain. Zhong Guo Zhen Jiu 2013; 33(8): 737-738. Skonnord T, Skjeie H, Brekke M, Grotle M, Lund I, Fetveit A. Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practiced the Acuback Study. BMJ Open 2012; 2(3): 1-6. Meng XJ, Yang L, Zhou RM. Clinical application of the penetrating needling technique from neiguan (PC 6) to waiguan (TE 5) by Professor LIU Kong-teng. Zhong Guo Zhen Jiu 2013; 33(7): 640-644. Du J. Acute lumbar sprain treated with acupuncture and moxibustion. Zhong Guo Zhen Jiu 2012; 32(12): 1098. The State Administration of Traditional Chinese Medicine. Diagnostic and Treatment Effect Criteria for TCM Diseases and Syndromes. Nanjing: Nanjing University Press, 1994: 201. Cesare AD, Giombini, Cesare MD, Ripani M, Vulpiani MC, Saraceni VM. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial. Complement Ther Med 2011; 19(1): 19-26. February 15, 2016 | Volume 36 | Issue 1 |
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J Tradit Chin Med 2016 February 15; 36(1): 19-25 ISSN 0255-2922 © 2016 JTCM. All rights reserved.
CLINICAL STUDY TOPIC
Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial
Lin Ruizhu, Zhu Ning, Liu Jian, Li Xinjian, Wang Yue, Zhang Jie, Xi Chaolei aa Lin Ruizhu, Zhu Ning, Liu Jian, Wang Yue, Zhang Jie, Xi Chaolei, Department of Rehabilitation Medicine, General Hospital of Ningxia Medical University, Yinchuan 750004, China Li Xinjian, Medical School of Acupuncture, Fujian University of Traditional Chinese Medicine, Fuzhou 350108, China Supported by Study the mechanism based on the p38MAPK signal pathway mediated by Cautery moxibustion therapy of Hui medicine treatment IDD (The National Natural Science Foundation of China, No. 81360567); Evaluation of different moxibustion doses for low back pain: a randomized controlled clinical trial of moxibustion therapy on CV4 (Ningxia Natural Science Foundation, No. NZ11208) Correspondence to: Prof. Xu Jianfeng, Department of Orthopedics and Traumatology, General Hospital of Ningxia Medical University, Yinchuan 750004, China. [email protected]; Prof. Wu Yongli, Department of Orthopedics and Traumatology, General Hospital of Ningxia Medical University, Yinchuan 750004, China. Wuyongli999@163. com Telephone: +86-951-6743730 Accepted: March 18, 2015
therapy (PT) group. Patients in the AM group were treated with acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture. Patients in the SAM group were treated with sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture. Conventional acupuncture was performed in the CA group, and physical therapy was applied in the PT group. Each treatment lasted for 20 min. Patients were assessed before and after treatment using a visual analogue scale (VAS) and the Roland Morris Questionnaire (RMQ). RESULTS: The VAS and RMQ scores in the AM group were significantly lower after than before treatment (P < 0.01). The AM group reported lower RMQ scores in after-treatment and 24 h after treatment and lower VAS score in 24 h after treatment in comparison with those of the CA, SAM, and PT groups (P < 0.05). CONCULSION: Acupuncture-movement therapy is effective for treating acute lumbar sprain with a persistent pain-relief and remarkable improvement of lumbar activity. Movement, that is, lumbar exercise during acupuncture, enhances the effect of acupuncture.
Abstract OBJECTIVE: Several studies have reported that acupuncture is effective for treatment of acute lumbar sprain, but they neglected to consider that acupuncture cannot remarkably improve lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy versus conventional acupuncture in the treatment of acute lumbar sprain.
© 2016 JTCM. Open access under CC BY-NC-ND license. Key words: Acupuncture; Movement; Exercise; Lumbar sprain; Randomized controlled trial
METHODS: Sixty patients were randomized into four groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical JTCM | www. journaltcm. com
INTRODUCTION Acute lumbar sprain refers to an acute injury of the lumbar muscles, fasciae, ligaments, or intervertebral 19
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facet joints caused by overburden, improper posture and movement, or insufficient preparation before exercise.1 It leads to severe lower back pain and limitation of spinal activities. Statistics show that acute lumbar sprain affects 60% to 80% of the general adult population, especially young adults and manual workers.2 This common health problem greatly decreases patients' quality of life.3 Nonsteroidal anti-inflammatory drugs and physical therapy are commonly used to treat acute lumbar sprain, but some drugs should be avoided because of their various side effects.4 Affected patients often seek help through complementary therapy. Acupuncture is usually adopted for treatment in such cases. The ability of acupuncture to effectively relieve pain has been confirmed by a considerable amount of research to date.5 Unfortunately, the long-term effects of acupuncture in relieving pain and improving lumbar activity are relatively poor. However, acupuncture-movement therapy solves this problem in many cases.6 Acupuncture-movement therapy is a new treatment technique for some locomotor and nervous system diseases. Acupuncture and movement promote and influence each other in the course of treatment. The doctor usually punctures acupoints distal to the lumbar region, and the patient is asked to exercise his or her waist while retaining the needles.7 The immediate analgesic effect of the acupuncture lays the foundation for lumbar exercise, while the exercise enhances the long-term effect of the acupuncture in relieving pain and improving lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy for treatment of acute lumbar sprain.
Ethics Committee of the General Hospital of Ningxia Medical University. Patients Patients received information about the study from newspapers and posters at the General Hospital of Ningxia Medical University and from the Internet in their communities. The treatment process was explained to each patient to ensure an understanding of the study. After signing a consent form, the patients were enrolled in the trial. The criteria for diagnosis and therapeutic effects for Traditional Chinese Medicine (TCM) diseases and syndromes issued by the State Administration of TCM were adopted for treatment and evaluation in this trial.8 Inclusion criteria The inclusion criteria were as follows: age of 20 to 60 years, ≤ 3-day course of acute lumbar sprain, visual analog scale (VAS) score of ≥ 4 (moderate to severe pain), no spinal surgery, no acupuncture treatment for acute lumbar sprain in the previous month, and no treatment since the onset of the acute lumbar sprain. Exclusion criteria The exclusion criteria were as follows: infectious diseases, tuberculosis, and rheumatic diseases; other serious diseases such as mental disorders, cancer, stroke, and myocardial infarction as well as cardiac pacemaker implantation; radicular pain indicative of nerve root compression; diagnosis of severe spinal canal stenosis, spondylolisthesis, or fibromyalgia; pregnancy; and physical or laboratory examination findings indicative of unsuitability for our study. Patients were instructed to undergo acupuncture and physical therapy for pain control. The use of nonsteroidal anti-inflammatory drugs and other therapies were monitored and recorded by the researchers, and these patients were analyzed separately.
METHODS Study design This randomized, single-assessor-blinded clinical trial was carried out in the General Hospital of Ningxia Medical University in China from May 2012 to January 2014. In total, 60 patients were observed. A computer-generated random number table was used. The 60 patients were randomized into 4 groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical therapy (PT) group. The trial statistician, who was not involved in the treatment administration or outcome collection, generated the schedule for the random allocation sequence, which was held in a secure cabinet only accessible to himself. To investigate whether the treatment preference had any influence on outcomes, each patient was asked which treatment he or she would prefer to receive before randomization. Due to the nature of the interventions, it was not possible to blind the doctor who provided the treatments. This study was approved by the JTCM | www. journaltcm. com
Interventions Acupuncture therapy and sham acupuncture therapy Acupuncture and sham acupuncture were carried out by certified acupuncture doctors with ≥ 5 years of clinical experience in the General Hospital of Ningxia Medical University. Yintang (EX-HN 3) was selected for treatment in the AM、CA and SAM groups. In the AM and CA group, the acupuncture point was routinely disinfected and a disposable stainless steel needle (0.30 × 25 mm; Huatuo Acupuncture, Suzhou, China) was inserted horizontally. The needle was retained for 20 min after arrival of Qi and then removed. In the SAM group, the acupuncture point was routinely disinfected and pressed with a semi-blunt needle fitted within a guide tube. The tube containing the needle was fixed onto the forehead with adhesive plaster. After 20 min, the tube and needle were removed. 20
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ment were also obtained from the patients via telephone and recorded by the researchers. The secondary outcome in this trial was motion limitation caused by the lumbar sprain. The motion limitation was assessed by the RMQ (range, 0-24 points, with 24 indicating the most severe limitation). The RMQ comprises 24 questions, and each has two possible responses.10 The RMQ scores were assessed before treatment, immediately after treatment, and 24 h after treatment.
Exercise The doctor prescribed the exercise program (lumbar flexion, stretching, and rotation) according to the condition of each individual patient. After the needle had been inserted in Yintang (EX-HN 3), the patient was asked to stand up. The doctor stood behind the patient with two hands supporting the patient's low back and asked him or her to exercise the lumbar region from small to large amplitude and from slow to fast speed, within the limit of his or her endurance. When the patient felt the lumbar muscles relax enough for active movement, he or she was encouraged to perform bending, stretching, and rotating exercises. The lumbar exercises lasted for 20 min until the acupuncture or sham acupuncture therapy was finished.
Safety monitoring The vital signs of each patient were checked before treatment. During treatment, the condition of each patient was carefully observed. Nausea, vomiting, fatigue, dizziness, pallor, hematoma, and any other adverse events related to acupuncture were recorded in detail.
Physical therapy Transcutaneous electrical nerve stimulation (TENS) was carried out by a certified physical therapist with ≥ 5 years' clinical experience in the General Hospital of Ningxia Medical University. The patients in the PT group were asked to lie on the treatment bed in a comfortable prone position. The treatment room was kept quiet and the temperature controlled at 25 ℃ to 29 ℃. A six-channel portable TENS instrument (model TS-6000; DANMETER A/S, Denmark) was used for treatment (medium-frequency sinusoidal waves, TENS form, 30-Ma intensity, and 50-µs pulse length) with 10- × 5-cm surface disposable electrodes placed on the painful spot of the lumbar region. All patients received treatment at the same time. Immediately after and 24 h after treatment, the patients were asked to perform self-assessments with the VAS and Roland Morris Questionnaire (RMQ).
Statistical analysis The data were analyzed with the Statistical Package for Social Sciences software (version 16.0; SPSS, Inc., Chicago, IL, USA). A P value of < 0.05 was deemed statistically significant. The measurement data were expressed as mean±standard deviation ( xˉ ± s). The VAS and RMQ scores were assessed by analysis of variance as between-group factors, and the three evaluations (before treatment, immediately after treatment, and 24 h after treatment) were assessed as within-group factors. The χ2 test or Wilcoxon test was used for categorical variables.
RESULTS A total of 71 patients with acute lumbar sprain passed the outpatient screening. Eleven patients were excluded either because they did not consent to the study or because they had been previously treated by acupuncture and moxibustion. Sixty patients who met the inclusion criteria were randomized into four groups. The 60 patients comprised 39 men and 21 women aged 22 to 58 years. The baseline age, sex, duration of acute lumbar sprain, VAS scores, and RMQ scores are shown in Table 1. No significant differences were noted among the
Evaluation The primary outcome in this trial was pain intensity. Before the treatment, the patients were instructed to adopt the posture that produced the most severe pain and to indicate this severity of pain on the VAS. The researchers recorded the VAS scores and postures of the patients. After treatment, the patients were asked to determine their VAS score while adopting the most painful posture as before.9 The VAS scores 24 h after treat-
Table 1 Comparison of age, sex, duration of disease, VAS score, and RMQ score in the four groups ( xˉ ± s) Items
AM group
SAM group
CA group
PT group
Age (years)
34.7±4.6
36.2±3.2
36.0±4.9
33.9±5.2
Male [n (%)]
9 (62.48)
10 (71.42)
9 (69.23)
8 (61.53)
Female [n (%)]
5 (37.52)
4 (28.58)
4 (30.77)
5 (38.47)
Duration (h)
25.7±5.7
27.8±4.3
27.2±5.2
24.8±6.8
VAS (scores)
74.9±9.8
69.3±10.5
72.6±11.5
69.0±12.6
RMQ (scores)
15.4±3.4
15.8±3.2
13.4±2.2
14.5±2.6
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement [sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min]; CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy (transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire. JTCM | www. journaltcm. com
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four groups. The mean baseline VAS score was 72.0 ± 5.7, indicating that our study included patients with moderate and severe pain intensity associated with acute lumbar sprain. Two patients in the PT group, one patient in the SAM group, and one patient in the CA group dropped out because they underwent additional treatments that were prohibited in our trial. One patient in the AM group dropped out because she fainted during the acupuncture treatment. One patient in the CA group dropped out because of deterioration of symptoms. The total dropout rate was 10%, and there was no statistical difference in the dropout rates among the four groups. The statistical analyses were carried out on the 54 patients who finished the whole trial and provided all required information (Figure 1).
Adverse events One patient in the AM group fainted during the acupuncture treatment and spontaneously recovered after a short rest with no special treatment. No adverse reactions occurred in the other groups. Adverse events were monitored and recorded by the researchers at every visit. Pain intensity scores (VAS) Changes in the VAS scores after the treatment are shown in Table 2. In the within-group comparison, the mean VAS score in each of the four groups decreased immediately after and 24 h after treatment (P < 0.01). In the AM group, the VAS score was 75 ± 10 before treatment, 29 ± 4 immediately after treatment, and 15 ± 3 24 h after treatment (P < 0.01).
Included sample with acute lumbar sprain (n = 60)
Ramdomized
Acupuncture movement group (start) (n = 15)
SHAM acupuncture movement group (start) (n = 15)
(CA) Conventional acupuncture group (start) (n = 15)
Post-treatment (n = 15)
Post-treatment (n = 15)
Post-treatment (n = 15)
1 drop out (additional treatments)
1dropout (fainted) 24 h after treatment (n = 14)
24 h after treatment (n = 14)
Transcutaneouselectrical nerve stimulation (start) (n = 15)
Post-treatment (n = 15) 2 drop out (additional treatments)
2 drop out (additional treatment, deterioration of symptoms) 24 h after treatment (n = 13)
24 h after treatment (n = 14)
Figure 1 Flow chart of the patients Table 2 Comparison of VAS scores in the four groups (scores, xˉ ± s) Group
n
Before treatment
After-treatment
24 h after treatment
AM
14
75±10
29±4
15±3a
SAM
14
69±11
42±5a
32±6acd
CA
13
73±11
31±6 ab
25±4ac
PT
13
69±13
32±7ab
31±8acd
ab
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement [sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min]; CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy(transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire; In the within-group comparison, the VAS scores before treatment were compared with those immediately after and 24 h after treatment in the four groups, aP < 0.01. In the between-group comparison, the VAS scores after treatment were compared in the AM, CA, and PT groups vs the SAM group, bP < 0.05; those 24 h after treatment were compared in the SAM, CA, and PT groups vs the AM group, cP < 0.05; and those 24 h after treatment were compared in the SAM and PT groups vs the CA group, dP < 0.05. JTCM | www. journaltcm. com
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Lin RZ et al. / Clinical Study Table 3 Comparison of RMQ scores in the four groups (scores, xˉ ± s) Group
n
before treatment
after-treatment
24 h after treatment
AM
14
15.4±3.4
6.7±1.8a
4.2±1.0a
SAM
14
15.8±3.2
10.3±2.5bc
7.8±1.4ad
CA
13
13.4±2.2
10.8±3.2bc
6.6±1.6ad
PT
13
14.5±2.6
11.3±2.7bc
7.2±2.2ad
Notes: AM: the acupuncture-movement [acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture, 20 min]; SAM: sham acupuncture-movement(sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture, 20 min); CA: conventional acupuncture [acupuncture at Yintang (EX-HN 3), 20 min]; PT: physical therapy (transcutaneous electrical nerve stimulation, 20 min); VAS: visual analog scale; RMQ: roland morris questionnaire; In the within-group comparison, the RMQ scores immediately after and 24 h after treatment were compared with those before treatment in the four groups, aP < 0.01 and bP < 0.05. In the between-group comparison, the RMQ scores after treatment were compared in the SAM, CA, and PT groups vs the AM group, c P < 0.05; and those 24 h after treatment were compared in the SAM, CA, and PT groups vs the AM group, dP < 0.05.
In the between-group comparison, the VAS score immediately after treatment in the SAM group was higher than those in the other groups (P < 0.05). At 24 h after treatment, the VAS score in the AM group was lower than those in the other groups (P < 0.05), while that in the CA group was higher than those in the SAM and PT groups (P < 0.05).
Acupuncture-movement therapy is a new treatment method for some locomotor diseases and nervous system diseases. The effects of acupuncture and movement promote each other. Doctors usually puncture distal points and retain the needles while the patient performs active movement or passive activity to exercise the affected part.11 Many clinical studies and meta-analyses have confirmed the effects of acupuncture and exercise for some diseases. Patients first receive acupuncture treatment and then begin to exercise the affected part until the acupuncture treatment is finished.12,13 This acupuncture plus exercise therapy is a superposition of two methods;14 it maximizes the synergy of the two, obtaining a better effect. In TCM, the main function of the meridians and collaterals is to transport Qi and blood. When Qi, blood, Yin, and Yang are not in balance, the meridian Qi will be stagnated or in disorder, leading to disease. Acupuncture can regulate the circulation of the meridian Qi and blood. Exercise is helpful for the flow of Qi and blood and for strengthened body resistance. Active movement or passive activity can also promote the flow of Qi and blood, enhancing the function of acupuncture treatment by conducting the needling sensation to the affected part.15 Huang Di Nei Jing states that "Arrival of Qi produces the effect." The analgesic effect of acupuncture, especially the immediate effect, is widely recognized.16 Exercise therapy helps to improve its long-term pain-suppressing effect.17 Acupuncture therapy mainly acts on the sensory system, while exercise is related to the motor system. There is a close interrelationship and interaction between the sensory and motor systems. Acupuncture-movement therapy has been successfully used in medical practice because of the very important effect of movement in controlling sensory affernets.18 Additionally, movement activates the central pain-inhibiting system, which gives out descending impulses to potentiate descending inhibition.19,20 The pain threshold is increased by acupuncture treatment, and the pain is then immediately relieved, laying the foundation for movement of the affected body part. Active or passive movement enhances the
RMQ scores Changes in the RMQ scores after the treatment are shown in Table 3. The RMQ scores in the four groups decreased immediately after and 24 h after treatment. In the AM group, the RMQ scores before treatment were lower than those immediately after and 24 h after treatment (P < 0.01). The RMQ scores before treatment in the SAM, CA, and PT groups were lower than those immediately after treatment (P < 0.05). There was a significant difference in the RMQ scores immediately before and 24 h after treatment in the SAM, CA, and PT groups (P < 0.01). In the between-group comparison, the RMQ scores immediately after and 24 h after treatment in the AM group were lower than those in the SAM, CA, and PT groups (P < 0.05). However, there was no significant difference in the RMQ scores immediately after and 24 h after treatment in the CA, SAM, and PT groups (P > 0.05).
DISCUSSION In the present study, a significant reduction in the VAS and RMQ scores in the AM group was observed immediately after and 24 h after treatment. At 24 h after treatment, the VAS score in the AM group was lower than those in the SAM, CA, and PT groups. Immediately after and 24 h after treatment, the RMQ score in the AM group was lower than those in the SAM, CA, and PT groups. These results indicate that acupuncture-movement therapy can immediately improve lumbar activity and has a good long-term analgesic effect. It was more effective than sham acupuncture-movement, conventional acupuncture, and physical therapy for acute lumbar sprain in this study. JTCM | www. journaltcm. com
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long-term pain-suppressing effect because the nerve impulse of movement and sensory are integrated at all levels of the peripheral and central nervous systems in acupuncture treatment. Active or passive movement can also re-establish normal motor patterns in the central nervous system, turning the abnormal activity model into a normal activity model. The affected body part is then able to maintain bio-mechanical stability, and a long-term pain-suppressing effect is obtained.21 In TCM, acute lumbar sprain is characterized by low back and leg pain caused by a sudden force that damages the Governing Vessel and Bladder Meridian, resulting in stagnation of Qi and blood in the lumbar region.22 Acupuncture-movement therapy is very effective in the early stage (the first 3 days) because the main problem in this stage is Qi stagnation. After 3 days, the damage extends into the blood system, and bloodletting therapy should be performed. In our study, Yintang (EX-HN3) was selected to regulate the flow of Qi for dredging the Governing Vessel. It is an extraordinary point located on the Governing Vessel, which is the sea of Yang meridians and functions to govern Yang and Qi. Exercising the lumbar region during acupuncture is helpful for promoting the flow of Qi of the Governing Vessel and Bladder Meridian.23 Thus, acupuncture-movement therapy can immediately improve the lumbar activity and has a good long-term analgesic effect. The RMQ score in the AM group immediately after and 24 h after treatment was lower than those in the SAM, CA, and PT groups. This shows that acupuncture-movement therapy can improve lumbar activity because of the re-establishment of normal motor patterns, which in turn allows the lumbar vertebrae to maintain stability and provides immediate pain relief. The VAS scores were reduced in the four groups immediately after treatment, although the VAS score in the SAM group immediately after treatment was higher than those in the AM, CA, and PT groups. This means that acupuncture increases the pain threshold; thus, the pain is temporarily relieved. Sham acupuncture does not have a good analgesic effect. At 24 h after treatment, the VAS score in the AM group was lower than those in the SAM, CA, and PT groups. The present study indicates that active movement is a decisive factor resulting in a good long-term analgesic effect. Exercising the lumbar region turns the abnormal activity model into a normal activity model of the lumbar muscles. This allows the lumbar vertebrae to maintain stability. Exercise is also an important factor in obtaining a good long-term analgesic effect.24 Exercise during acupuncture is helpful for promoting the flow of Qi and thus removing obstruction of the Governor Vessel. Huang Di Nei Jing stated, "Pain is caused by obstruction of meridians. Pain disappears when the meridians are unobstructed." The present study has several limitations, such as the small sample size, finite treatment time, and insuffiJTCM | www. journaltcm. com
cient blinding of the patients and assessor. Further studies with larger sample sizes and adequate blinding are needed. If the course of acute lumbar sprain is > 3 days, Qi stagnation may cause blood stasis. This is why TCM holds that "Normal flow of Qi ensures normal circulation of blood, while stagnation of Qi leads to blood stasis." Bloodletting therapy should be adopted for treatment of blood stasis; this will be discussed in a future study. Only patients with acute lumbar sprain of a ≤ 3-day duration were enrolled in the present study. Acupuncture-movement therapy provides a synergistic effect of acupuncture and movement with a stronger stimulation. Because one patient in this study fainted, however, doctors should carefully observe the patient's condition during treatment. Acupuncture-movement therapy is effective for acute lumbar sprain. Lumbar exercise during acupuncture enhances the effect of acupuncture by providing persistent pain relief and remarkable improvement of lumbar activity.
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