- Email: [email protected]
The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study
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Journal of the Formosan Medical Association xxx (xxxx) xxx
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.jfma-online.com
Original Article
The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study Ming-Yu Lo a, Chueh-Hung Wu b, Jer-Junn Luh c, Tyng-Guey Wang b,e, Li-Chen Fu d,e, Jaung-Geng Lin a,**, Jin-Shin Lai b,e,* a School of Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medicine University, China Medical University, Taichung, Taiwan b Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan c School of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan d Department of Computer Science & Information Engineering & Department of Electrical Engineering, College of Electrical Engineering & Computer Science, National Taiwan University, Taipei, Taiwan e Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan
Received 2 January 2019; received in revised form 22 February 2019; accepted 14 March 2019
KEYWORDS Frozen shoulder syndrome (FSS); Electroacupuncture; True electroacupuncture group (TEAG); Sham electroacupuncture group (SEAG)
Purpose: Frozen shoulder syndrome (FSS) causes pain and reduces the range of motion in the shoulder joint. To investigate the short and medium-term effects of electroacupuncture in people with FSS, we evaluated the therapeutic effects of true and sham electroacupuncture on pain relief and improvement of shoulder function. Methods: In this randomized, single-blind controlled clinical trial, 21 subjects with FSS were randomly assigned to two groups: a true electroacupuncture group (TEAG) and a sham electroacupuncture group (SEAG). The two groups underwent 18 sessions of treatment over approximately 6e9 weeks and were then followed up at 1, 3, and 6 months. Their effectiveness for alleviating the intensity of shoulder pain was evaluated with a visual analog scale (VAS), while improved shoulder mobility was evaluated by the active range of motion (AROM) and passive range of motion (PROM), and shoulder functional ability was evaluated using the Shoulder Pain and Disability Index (SPADI). Results: It demonstrated that the TEAG or SEAG showed lasting effects at 1, 3, and 6 months, although with no significant difference between these two groups in the shoulder functional ability outcomes. However, the decline in the VAS occurred earlier in the TEAG than the SEAG.
* Corresponding author. Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan. Fax: þ88622382 5751. ** Corresponding author. Fax: þ88622823 4326. E-mail addresses: [email protected] (J.-G. Lin), [email protected] (J.-S. Lai). https://doi.org/10.1016/j.jfma.2019.03.012 0929-6646/Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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M.-Y. Lo et al. Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG. An increase in the abduction angle after electroacupuncture and manual rehabilitation was also apparent. Conclusion: These results suggest that electroacupuncture plus rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically. Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/bync-nd/4.0/).
Introduction Frozen shoulder syndrome (FSS) is a painful and debilitating condition that is very commonly seen in clinical practice, affecting 2%e5% of the general population.1 FSS rarely occurs before age 40, and generally involves persons aged 50e70 years. Women are affected slightly more frequently than men.2 FSS can be formally classified as (1) primary frozen shoulder due to adhesive pericapsulitis and (2) secondary frozen shoulder resulting from a sprain, strain, tendinopathy, tendon tear, or bursitis. To relieve pain, acetaminophen or non-steroidal antiinflammatory drugs and rehabilitation intervention are the first-line options for patients with FSS.3,4 However, these treatments usually bring only temporary pain relief and their effect on medium-term outcome is not obvious. Recently, acupuncture has been used as a treatment for chronic pain that causes fewer adverse reactions than opioid analgesics and anti-inflammatory medications.5e7 Many studies have been performed to evaluate the effectiveness of acupuncture for frozen shoulder pain including its strength to relieve pain.8,9 It is believed that acupuncture mediates its effects by releasing endogenous opioids in the body that relieve pain, by overriding pain signals in the nerves, or by allowing energy (qi) or blood to flow freely through the body.10 Electroacupuncture (EA), the delivery of a pulsed electric current via acupuncture needles, is considered to further enhance the effectiveness of acupuncture analgesia. It is inferred that EA enhances the metabolism during treatment, promotes blood circulation, improves tissue nutrition, and eliminates inflammation and edema.11 EA has been shown to relieve frozen shoulder pain and thus promote the exercise range of motion. One review article reported that EA produced a significantly greater reduction in the intensity of pain than placebo EA.12 However, medium-term follow-up data are lacking, and little evidence has been found to support the medium-term benefits of EA for the treatment of chronic shoulder pain. This randomized, single-blind, shamacupuncture controlled clinical trial was performed to investigate the short-term and medium-term efficacy of EA as a treatment for FSS based on the meridian philosophy of acupuncture point and non-acupuncture point treatment.
(201207036RIB). All participants gave their informed consent. The study period was from December 2012 to August 2014. The inclusion criteria for the participants with FSS were: (1) age 20e70 years; (2) pain with restricted ROM in the unilateral shoulder for more than 3 months; (3) pain score > 3 in a visual analog scale (VAS) of 10; (4) no fracture, dislocation, or arthritis in the shoulder region evaluated by routine x-ray examination; (5) no communication problems in Mandarin or Taiwan dialect. Exclusion criteria were: (1) scheduled for shoulder arthroscopy or surgery; (2) significant shoulder trauma within 2 years; (3) cervical radiculopathy or other neurological deficits in the involved upper limb.
Intervention The subjects all received EA for 18 sessions (2e3 sessions per week). Each treatment session lasted approximately 80 min including 20 min for EA. The participant sat in a chair and exposed the affected shoulder, both knees and calves. Disposable number #30 1.5 cun (Chinese anatomical inch) needles were inserted through the skin at specific points according to traditional Chinese medicine (TCM) to treat the shoulder pain. The procedure flowchart is provided in Fig. 1. VAS and ROM were measured before each treatment.
Materials and methods Participants The study protocol was approved by the institutional review board of National Taiwan University Hospital
Figure 1 Procedure flowchart. Pre-treatment intensity of shoulder pain was evaluated by VAS, joint shoulder mobility by AROM and PROM measurements, and shoulder functional ability by SPADI.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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True electroacupuncture group (TEAG) The true EA points were: front part of shoulder (Jian qian UE12), shoulder-three-points (Jian yu LI15, Jian liao TE14, Nao shu SI10), then Yan lin quan GB34 and Tiao kou ST38 on both legs13,14; a total of 8 needles were used per procedure.15 The needles were twisted and turned, and operators elicited sensations of tingling, numbness, soreness, dull pain, heaviness, or distention. The needles were then connected with the electric needle machine. Stimulation occurred with an alternating frequency of 2e3 Hz at a pulse duration of 100e400 ms for 20 min. The intensity of stimulation was adjusted to a tolerance level of just below the pain threshold. All participants also received conventional physiotherapy including hot packs for 20 min, followed by a 5e10 min exercise including manual PROM of the shoulder by a qualified physiotherapist.
Sham electroacupuncture group (SEAG) The SEAG participants all received the same treatment as the TEAG except for the locations of needle insertion; the needles were inserted 1e2 cm around the actual acupuncture points as shown in Fig. 2.
Table 1 Demographic participants. Characteristics Age (years) Sex Involved side
Male Female Right Left
characteristics
of the study
TEAG (n Z 11)
SEAG (n Z 10)
60.8 5.1 6 (55%) 5 (45%) 4 (36%) 7 (64%)
58.3 7.1 5 (50%) 5 (50%) 5 (50%) 5 (50%)
and PROM), including the following angles: flexion (FL), extension (EXT), abduction (ABD), horizontal abduction (H Abd), horizontal adduction (H Add), internal rotation (IR), and external rotation (ER). We also compared the study groups for functional ability of the shoulder evaluated by the Shoulder Pain and Disability Index (SPADI), using the evaluation aspects of pain, disability, and total score. In order to measure and record the ROM of the shoulder joint, we have developed an unrestrained inertia motion unit (IMU) measurement system to replace the traditional goniometer. Therapists can operate the system more simply and can also free both hands to perform the AROM and PROM tests.16
Results Measurement Participants We compared the TEAG and SEAG measurements of shoulder pain intensity evaluated by VAS, and the shoulder mobility was evaluated by active and passive range of motion (AROM
Figure 2
The baseline characteristics of the 21 participants are summarized (Table 1). Before the intervention began, t-
Electroacupuncture points for the TEAG and SEAG.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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M.-Y. Lo et al.
Pain intensity and shoulder functional ability We observed a significant decrease in shoulder pain intensity as evaluated by VAS, and an improvement in shoulder functional ability evaluated by the SPADI after 18 sessions (Post) and at 1, 3, and 6 months compared with pre-treatment values (Pre), and the effects lasted for 6 months in both the TEAG and SEAG. Pain relief did not differ significantly between the two groups, and true EA was no more effective than sham EA in reducing shoulder pain as well as SPADI in the short- or medium-term (specifically, point location did not make a difference) (Fig. 3A, B). However, the decrease in shoulder pain intensity during AROM evaluated by VAS in the TEAG occurred earlier than in the SEAG (Fig. 4).
ROM
Figure 3 (A) Differences in the shoulder pain intensity evaluated by VAS before and after treatment in the TEAG and SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.) (B) Differences between the TEAG and SEAG SPADI-TOTAL. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.)
tests were used to compare the TEAG and SEAG; there were no significant sex or age differences between the groups.
In both the TEAG and SEAG, after 18 treatment sessions, there was a significant improvement in AROM and PROM, in particular showing a significant difference in PROM (Fig. 5). However, there was no significant difference between the TEAG and the SEAG after the 18 treatment sessions (Post) over 6e9 weeks and at 1, 3, and 6 months follow-up. Detailed analysis of the participants’ flexion and abduction scores revealed a greater increase of the AROM angles in the TEAG than the SEAG (Fig. 6). Meanwhile, upon combining the EA (T2) and rehabilitation (T3) we found that there was a significant improvement in the AROM angle of abduction in the TEAG with rehabilitation (T3), especially from the forth session. This indicates that combining the effects of EA (T2) and rehabilitation (T3) show significant differences in ROM in comparison to Pre-intervention (Fig. 7).
Adverse events No significant adverse events were reported in either group. The risks associated with acupuncture treatment are
Figure 4 Comparison of pain intensity (VAS) value between the TEAG and the SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01). Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 5
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AROM (A) (B) and PROM(C) (D) compared with Pre between TEAG and SEAG.
generally minimal (such as infection and hematoma), and their rates of occurrence are very low. Acupuncture also has high rates of patient acceptance relative to other methods of treatment.
Discussion Although acupuncture is increasingly recommended and used to treat pain associated with FSS, the evidence to support its use remains equivocal. Classical acupuncture remedies for frozen shoulder pain are designed by selecting local, distal, and tender (ashi) points according to the course of the meridians, and conducted according to the principles of TCM. In this single-blind, randomized controlled trial, the improvements observed in both the TEAG and SEAG were maintained at the 6-month follow-up session. However, this study showed that the effect of EA as an FSS intervention was similar when using EA as well as non-EA points after
electrical stimulation. In other words, TEAG treatments based on the philosophy of TCM and using the TCM standard points did not result in significantly greater improvement in shoulder pain and function after 18 sessions or at 1, 3, and 6 months than sham EA. In a review article on frozen shoulder pain, Gladys found that EA treatment was similar to interferential electrotherapy.17 Another previous article reported that EA further enhances the analgesic effects of acupuncture, and it was supposed that the mechanisms might be similar to those in transcutaneous electrical nerve stimulation.18 Nevertheless, it remains relevant that the effect of intervention in the SEAG is parallel to that in TEAG regarding the above outcomes. However, there were some differences including the earlier occurrence of pain relief in the TEAG than SEAG during the 18-session course as evaluated by VAS, and the significant improvement of AROM of the flexion and abduction angles. In previous frozen shoulder pain studies involving control groups, the importance of sham-controlled, randomized
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 5
clinical trials to examine the strong placebo effects of EA has been debated.19,20 For example, there are uncertainties regarding the choice of control acupuncture points, and the inherent difficulty in the use of appropriate controls, such as placebo and sham acupuncture groups. In our study, an identical needling method at non-EA points on the shoulder was chosen as the control intervention for verification of the meridian theory. The results of this study suggest that non-EA points on the shoulder might have very similar effects as EA points for FSS pain relief. We performed detailed analysis of the previous literature discussing the control design for EA treatment of frozen shoulder pain, and found that the results of this study were different from the previous reports. For example, in a study reported by Antoni, a blunt tip needle was easily identified by the participants because of their past acupuncture experience.21 Also, regarding EA point specificity, Go Eun Lee found significant differences in EA points and non-EA points when using the shallow technique,
(continued).
while deep acupuncture was shown to be more effective than shallow acupuncture.22 In contrast to the results of our study involving non-EA points according to meridian theory, the results of previous studies suggest that the participants easily distinguish between true EA and non-penetrating sham EA, since many people in Taiwan have previously experienced EA. Meanwhile, there were few significant differences in the VAS and ROM of patients treated with true compared to sham EA, probably due to small sample sizes which may be explained by Type II error. Nevertheless, in our study, there were significant improvements in the AROM angle of abduction of participants in the TEAG with rehabilitation (T3) after EA (T2). This result suggests that EA is effective for reducing pain whereas physical therapy is better for improving ROM. From our results, we infer that electroacupuncture combined with rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 6 Flexion-AROM (A) and PROM (B) between the TEAG and SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.)
Figure 7 The change in the angle of abduction during AROM (Pre-T2-T3) after electroacupuncture (T2) and after rehabilitation (T3) compared to before treatment (Pre) in the TEAG. Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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8 The integration of Western and Chinese remedies may yield better outcomes than either approach by itself.
Conflict of interest The authors have no conflicts of interest relevant to this article.
Acknowledgments This study was sponsored by National Taiwan University Cutting-Edge Steering Research Projects (10R71617, 102R7617, &103R7617). The authors are grateful to Yi-Ning Cheng for data collection and data analysis. We also thank Dr. Yao-Hsian Huang, Dr. Chih-Ying Chen, and Dr. Chien-Kuo Wu for participating as investigators.
Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jfma.2019.03.012.
References 1. Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res 2000;372:95e109. 2. Rizk TE, Pinals RS. Frozen shoulder. Semin Arthritis Rheum 1982;11:440e52. 3. Codsi M, Howe CR. Shoulder Conditions. Diagnosis and treatment guideline. Phys Med Rehabil Clin 2015;26:467e89. 4. Molsberger AF, Schneider T, Gotthardt H, Drabik A. German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multicentre trial in an outpatient care environment. Pain 2010;151: 146e54. 5. Patel M, Gutzwiller F, Paccaud F, Marazzi A. A meta-analysis of acupuncture for chronic pain. Int J Epidemiol 1989;18:900e6. 6. Junnila SY. Long-term treatment of chronic pain with acupuncture. Part I. Acupunct Electro-Ther Res 1987;12: 23e36. 7. Lewith GT. How effective is acupuncture in the management of pain? J R Coll Gen Pract 1984 May;34:275e8. 8. Sun K, Chan K, Lo S, Fong D. Acupuncture for frozen shoulder. Hong Kong Med J 2001;7:381e91. 9. Lathia AT, Jung SM, Chen LX. Efficacy of acupuncture as a treatment for chronic shoulder pain. J Altern Complement Med 2009;15:613e8.
M.-Y. Lo et al. 10. Green S, Buchbinder R, Hetrick S. Acupuncture for shoulder pain. Cochrane Database Syst Rev 2005;18. 11. Molsberger AF, Mau J, Gotthardt H, Schneider T, Drabik A. Designing an electro acupuncture study to meet evidencebased medical criteria: methodological considerations for logistic design and development of treatment interventions arising from the German randomized controlled electro acupuncture trial on chronic shoulder pain (GRASP). Eur J Med Res 2004;9:405e11. 12. Birch S, Hammerschlag R, Trinh K, Zaslawski C. The nonspecific electro of acupuncture treatment when and how to control for them. Clin Electro Acupunct Points Orient Med 2002;3:20e5. 13. Yang C, Lv T, Yu T, Wong S, Lu M, Li Y. Acupuncture at tiaokou (ST38) for shoulder adhesive capsulitis: what strengths does it have? A systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Altern Med 2018; 11:2018. 14. Hee RS, Jihye S, Eun JL, Jin BC, Yeon CP, Yong HB, et al. Chuna manual therapy combined with acupuncture and cupping for frozen shoulder (adhesive capsulitis): study protocol for a multicenter, randomized, patient-assessor blind, clinical trial. Eur J Integr Med 2018;19:1e9. 15. Jaung GL. Newly edited color book of acupuncture and moxibustion. 1st ed. Taipei: Jyin Publishing Company; 2009. p. 121. 16. Li CF, Wei WW, Guan DL, Yi WL. A gravity compensation-based upper limb rehabilitation Robot, 2012 American control conference fairmont Queen Elizabeth, Montreal, Canada. 2012. p. 4819. 17. Cheing GL, So EM, Chao CY. Effectiveness of electroacupuncture and interferential eloctrotherapy in the management of frozen shoulder. J Rehabil Med 2008 Mar;40: 166e70. 18. Nabeta T, Kawakita K. Relief of chronic neck pain and shoulder pain by anual Electro acupuncture to tender points-a shamcontrolled randomized trial. Complement Ther Med 2002;10: 217e22. 19. Kleinhenz J, Streitberger K, Windeler J, Gussbacher A, Mavridis G, Martin E. Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendonitis. Pain 1999;83:235e41. 20. Moore ME, Berk SN. Acupuncture for chronic shoulder pain. An experimentalstudy with attention to the role of placebo and hypnotic susceptibility. Ann Intern Med 1976;84:381e4. 21. Guerra JA, Andre MDC, Leon EBB, Lopez MV, Lopez TM, Morilla FAV, et al. Randomized trial of long term effect electro acupuncture for shoulder pain. Pain 2004;112:289e98. 22. Lee GE, Son C, Lee J, Lee SH, Lee HJ, Lee KJ, et al. Acupuncture for shoulder pain after stroke. A randomized controlled clinical trial. Eur J Integr Med 2016;8:373e83.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
MODEL
Journal of the Formosan Medical Association xxx (xxxx) xxx
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.jfma-online.com
Original Article
The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study Ming-Yu Lo a, Chueh-Hung Wu b, Jer-Junn Luh c, Tyng-Guey Wang b,e, Li-Chen Fu d,e, Jaung-Geng Lin a,**, Jin-Shin Lai b,e,* a School of Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medicine University, China Medical University, Taichung, Taiwan b Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan c School of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan d Department of Computer Science & Information Engineering & Department of Electrical Engineering, College of Electrical Engineering & Computer Science, National Taiwan University, Taipei, Taiwan e Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan
Received 2 January 2019; received in revised form 22 February 2019; accepted 14 March 2019
KEYWORDS Frozen shoulder syndrome (FSS); Electroacupuncture; True electroacupuncture group (TEAG); Sham electroacupuncture group (SEAG)
Purpose: Frozen shoulder syndrome (FSS) causes pain and reduces the range of motion in the shoulder joint. To investigate the short and medium-term effects of electroacupuncture in people with FSS, we evaluated the therapeutic effects of true and sham electroacupuncture on pain relief and improvement of shoulder function. Methods: In this randomized, single-blind controlled clinical trial, 21 subjects with FSS were randomly assigned to two groups: a true electroacupuncture group (TEAG) and a sham electroacupuncture group (SEAG). The two groups underwent 18 sessions of treatment over approximately 6e9 weeks and were then followed up at 1, 3, and 6 months. Their effectiveness for alleviating the intensity of shoulder pain was evaluated with a visual analog scale (VAS), while improved shoulder mobility was evaluated by the active range of motion (AROM) and passive range of motion (PROM), and shoulder functional ability was evaluated using the Shoulder Pain and Disability Index (SPADI). Results: It demonstrated that the TEAG or SEAG showed lasting effects at 1, 3, and 6 months, although with no significant difference between these two groups in the shoulder functional ability outcomes. However, the decline in the VAS occurred earlier in the TEAG than the SEAG.
* Corresponding author. Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan. Fax: þ88622382 5751. ** Corresponding author. Fax: þ88622823 4326. E-mail addresses: [email protected] (J.-G. Lin), [email protected] (J.-S. Lai). https://doi.org/10.1016/j.jfma.2019.03.012 0929-6646/Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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M.-Y. Lo et al. Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG. An increase in the abduction angle after electroacupuncture and manual rehabilitation was also apparent. Conclusion: These results suggest that electroacupuncture plus rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically. Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/bync-nd/4.0/).
Introduction Frozen shoulder syndrome (FSS) is a painful and debilitating condition that is very commonly seen in clinical practice, affecting 2%e5% of the general population.1 FSS rarely occurs before age 40, and generally involves persons aged 50e70 years. Women are affected slightly more frequently than men.2 FSS can be formally classified as (1) primary frozen shoulder due to adhesive pericapsulitis and (2) secondary frozen shoulder resulting from a sprain, strain, tendinopathy, tendon tear, or bursitis. To relieve pain, acetaminophen or non-steroidal antiinflammatory drugs and rehabilitation intervention are the first-line options for patients with FSS.3,4 However, these treatments usually bring only temporary pain relief and their effect on medium-term outcome is not obvious. Recently, acupuncture has been used as a treatment for chronic pain that causes fewer adverse reactions than opioid analgesics and anti-inflammatory medications.5e7 Many studies have been performed to evaluate the effectiveness of acupuncture for frozen shoulder pain including its strength to relieve pain.8,9 It is believed that acupuncture mediates its effects by releasing endogenous opioids in the body that relieve pain, by overriding pain signals in the nerves, or by allowing energy (qi) or blood to flow freely through the body.10 Electroacupuncture (EA), the delivery of a pulsed electric current via acupuncture needles, is considered to further enhance the effectiveness of acupuncture analgesia. It is inferred that EA enhances the metabolism during treatment, promotes blood circulation, improves tissue nutrition, and eliminates inflammation and edema.11 EA has been shown to relieve frozen shoulder pain and thus promote the exercise range of motion. One review article reported that EA produced a significantly greater reduction in the intensity of pain than placebo EA.12 However, medium-term follow-up data are lacking, and little evidence has been found to support the medium-term benefits of EA for the treatment of chronic shoulder pain. This randomized, single-blind, shamacupuncture controlled clinical trial was performed to investigate the short-term and medium-term efficacy of EA as a treatment for FSS based on the meridian philosophy of acupuncture point and non-acupuncture point treatment.
(201207036RIB). All participants gave their informed consent. The study period was from December 2012 to August 2014. The inclusion criteria for the participants with FSS were: (1) age 20e70 years; (2) pain with restricted ROM in the unilateral shoulder for more than 3 months; (3) pain score > 3 in a visual analog scale (VAS) of 10; (4) no fracture, dislocation, or arthritis in the shoulder region evaluated by routine x-ray examination; (5) no communication problems in Mandarin or Taiwan dialect. Exclusion criteria were: (1) scheduled for shoulder arthroscopy or surgery; (2) significant shoulder trauma within 2 years; (3) cervical radiculopathy or other neurological deficits in the involved upper limb.
Intervention The subjects all received EA for 18 sessions (2e3 sessions per week). Each treatment session lasted approximately 80 min including 20 min for EA. The participant sat in a chair and exposed the affected shoulder, both knees and calves. Disposable number #30 1.5 cun (Chinese anatomical inch) needles were inserted through the skin at specific points according to traditional Chinese medicine (TCM) to treat the shoulder pain. The procedure flowchart is provided in Fig. 1. VAS and ROM were measured before each treatment.
Materials and methods Participants The study protocol was approved by the institutional review board of National Taiwan University Hospital
Figure 1 Procedure flowchart. Pre-treatment intensity of shoulder pain was evaluated by VAS, joint shoulder mobility by AROM and PROM measurements, and shoulder functional ability by SPADI.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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True electroacupuncture group (TEAG) The true EA points were: front part of shoulder (Jian qian UE12), shoulder-three-points (Jian yu LI15, Jian liao TE14, Nao shu SI10), then Yan lin quan GB34 and Tiao kou ST38 on both legs13,14; a total of 8 needles were used per procedure.15 The needles were twisted and turned, and operators elicited sensations of tingling, numbness, soreness, dull pain, heaviness, or distention. The needles were then connected with the electric needle machine. Stimulation occurred with an alternating frequency of 2e3 Hz at a pulse duration of 100e400 ms for 20 min. The intensity of stimulation was adjusted to a tolerance level of just below the pain threshold. All participants also received conventional physiotherapy including hot packs for 20 min, followed by a 5e10 min exercise including manual PROM of the shoulder by a qualified physiotherapist.
Sham electroacupuncture group (SEAG) The SEAG participants all received the same treatment as the TEAG except for the locations of needle insertion; the needles were inserted 1e2 cm around the actual acupuncture points as shown in Fig. 2.
Table 1 Demographic participants. Characteristics Age (years) Sex Involved side
Male Female Right Left
characteristics
of the study
TEAG (n Z 11)
SEAG (n Z 10)
60.8 5.1 6 (55%) 5 (45%) 4 (36%) 7 (64%)
58.3 7.1 5 (50%) 5 (50%) 5 (50%) 5 (50%)
and PROM), including the following angles: flexion (FL), extension (EXT), abduction (ABD), horizontal abduction (H Abd), horizontal adduction (H Add), internal rotation (IR), and external rotation (ER). We also compared the study groups for functional ability of the shoulder evaluated by the Shoulder Pain and Disability Index (SPADI), using the evaluation aspects of pain, disability, and total score. In order to measure and record the ROM of the shoulder joint, we have developed an unrestrained inertia motion unit (IMU) measurement system to replace the traditional goniometer. Therapists can operate the system more simply and can also free both hands to perform the AROM and PROM tests.16
Results Measurement Participants We compared the TEAG and SEAG measurements of shoulder pain intensity evaluated by VAS, and the shoulder mobility was evaluated by active and passive range of motion (AROM
Figure 2
The baseline characteristics of the 21 participants are summarized (Table 1). Before the intervention began, t-
Electroacupuncture points for the TEAG and SEAG.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Pain intensity and shoulder functional ability We observed a significant decrease in shoulder pain intensity as evaluated by VAS, and an improvement in shoulder functional ability evaluated by the SPADI after 18 sessions (Post) and at 1, 3, and 6 months compared with pre-treatment values (Pre), and the effects lasted for 6 months in both the TEAG and SEAG. Pain relief did not differ significantly between the two groups, and true EA was no more effective than sham EA in reducing shoulder pain as well as SPADI in the short- or medium-term (specifically, point location did not make a difference) (Fig. 3A, B). However, the decrease in shoulder pain intensity during AROM evaluated by VAS in the TEAG occurred earlier than in the SEAG (Fig. 4).
ROM
Figure 3 (A) Differences in the shoulder pain intensity evaluated by VAS before and after treatment in the TEAG and SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.) (B) Differences between the TEAG and SEAG SPADI-TOTAL. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.)
tests were used to compare the TEAG and SEAG; there were no significant sex or age differences between the groups.
In both the TEAG and SEAG, after 18 treatment sessions, there was a significant improvement in AROM and PROM, in particular showing a significant difference in PROM (Fig. 5). However, there was no significant difference between the TEAG and the SEAG after the 18 treatment sessions (Post) over 6e9 weeks and at 1, 3, and 6 months follow-up. Detailed analysis of the participants’ flexion and abduction scores revealed a greater increase of the AROM angles in the TEAG than the SEAG (Fig. 6). Meanwhile, upon combining the EA (T2) and rehabilitation (T3) we found that there was a significant improvement in the AROM angle of abduction in the TEAG with rehabilitation (T3), especially from the forth session. This indicates that combining the effects of EA (T2) and rehabilitation (T3) show significant differences in ROM in comparison to Pre-intervention (Fig. 7).
Adverse events No significant adverse events were reported in either group. The risks associated with acupuncture treatment are
Figure 4 Comparison of pain intensity (VAS) value between the TEAG and the SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01). Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 5
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AROM (A) (B) and PROM(C) (D) compared with Pre between TEAG and SEAG.
generally minimal (such as infection and hematoma), and their rates of occurrence are very low. Acupuncture also has high rates of patient acceptance relative to other methods of treatment.
Discussion Although acupuncture is increasingly recommended and used to treat pain associated with FSS, the evidence to support its use remains equivocal. Classical acupuncture remedies for frozen shoulder pain are designed by selecting local, distal, and tender (ashi) points according to the course of the meridians, and conducted according to the principles of TCM. In this single-blind, randomized controlled trial, the improvements observed in both the TEAG and SEAG were maintained at the 6-month follow-up session. However, this study showed that the effect of EA as an FSS intervention was similar when using EA as well as non-EA points after
electrical stimulation. In other words, TEAG treatments based on the philosophy of TCM and using the TCM standard points did not result in significantly greater improvement in shoulder pain and function after 18 sessions or at 1, 3, and 6 months than sham EA. In a review article on frozen shoulder pain, Gladys found that EA treatment was similar to interferential electrotherapy.17 Another previous article reported that EA further enhances the analgesic effects of acupuncture, and it was supposed that the mechanisms might be similar to those in transcutaneous electrical nerve stimulation.18 Nevertheless, it remains relevant that the effect of intervention in the SEAG is parallel to that in TEAG regarding the above outcomes. However, there were some differences including the earlier occurrence of pain relief in the TEAG than SEAG during the 18-session course as evaluated by VAS, and the significant improvement of AROM of the flexion and abduction angles. In previous frozen shoulder pain studies involving control groups, the importance of sham-controlled, randomized
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 5
clinical trials to examine the strong placebo effects of EA has been debated.19,20 For example, there are uncertainties regarding the choice of control acupuncture points, and the inherent difficulty in the use of appropriate controls, such as placebo and sham acupuncture groups. In our study, an identical needling method at non-EA points on the shoulder was chosen as the control intervention for verification of the meridian theory. The results of this study suggest that non-EA points on the shoulder might have very similar effects as EA points for FSS pain relief. We performed detailed analysis of the previous literature discussing the control design for EA treatment of frozen shoulder pain, and found that the results of this study were different from the previous reports. For example, in a study reported by Antoni, a blunt tip needle was easily identified by the participants because of their past acupuncture experience.21 Also, regarding EA point specificity, Go Eun Lee found significant differences in EA points and non-EA points when using the shallow technique,
(continued).
while deep acupuncture was shown to be more effective than shallow acupuncture.22 In contrast to the results of our study involving non-EA points according to meridian theory, the results of previous studies suggest that the participants easily distinguish between true EA and non-penetrating sham EA, since many people in Taiwan have previously experienced EA. Meanwhile, there were few significant differences in the VAS and ROM of patients treated with true compared to sham EA, probably due to small sample sizes which may be explained by Type II error. Nevertheless, in our study, there were significant improvements in the AROM angle of abduction of participants in the TEAG with rehabilitation (T3) after EA (T2). This result suggests that EA is effective for reducing pain whereas physical therapy is better for improving ROM. From our results, we infer that electroacupuncture combined with rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically.
Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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Figure 6 Flexion-AROM (A) and PROM (B) between the TEAG and SEAG. (The data are expressed as mean SD; *P < 0.05, **P < 0.01, ***P < 0.001.)
Figure 7 The change in the angle of abduction during AROM (Pre-T2-T3) after electroacupuncture (T2) and after rehabilitation (T3) compared to before treatment (Pre) in the TEAG. Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012
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8 The integration of Western and Chinese remedies may yield better outcomes than either approach by itself.
Conflict of interest The authors have no conflicts of interest relevant to this article.
Acknowledgments This study was sponsored by National Taiwan University Cutting-Edge Steering Research Projects (10R71617, 102R7617, &103R7617). The authors are grateful to Yi-Ning Cheng for data collection and data analysis. We also thank Dr. Yao-Hsian Huang, Dr. Chih-Ying Chen, and Dr. Chien-Kuo Wu for participating as investigators.
Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jfma.2019.03.012.
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Please cite this article as: Lo M-Y et al., The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study, Journal of the Formosan Medical Association, https://doi.org/10.1016/ j.jfma.2019.03.012