Effect of ultrasound-guided acupotomy vs electro-acupuncture on knee osteoarthritis: a randomized controlled study

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J Tradit Chin Med 2016 August 15; 36(4): 444-449 ISSN 0255-2922 © 2016 JTCM. All rights reserved.

CLINICAL STUDY TOPIC

Effect of ultrasound-guided acupotomy vs electro-acupuncture on knee osteoarthritis: a randomized controlled study

Ding Yu, Wang Yuexiang, Shi Xian, Luo Yun, Gao Yuhong, Pan Jingkun aa Ding Yu, Shi Xian, Department of Acupuncture & Moxbustion, General Hospital of Chinese People's Liberation Army, Beijing 100853, China Wang Yuexiang, Department of Ultrasound, General Hospital of Chinese People's Liberation Army, Beijing 100853, China Luo Yun, Gao Yuhong, Institute of Geriatrics, General Hospital of Chinese People's Liberation Army, Beijing 100853, China Supported by Beijing Medical Research Development Fund: the Clinical Study on Ultrasound-guided Needle-knife Treatment of Knee Osteoarthritis (No. SF-2009-46) Correspondence to: Ding Yu, Department of Acupuncture & Moxbustion, General Hospital of Chinese People's Liberation Army, Beijing 100853, China. [email protected] Telephone: +86-10-66937414; +86-15601392560 Accepted: January 22, 2016

changes in HSS index before and after the therapy (P < 0.01). And there was remarkable difference in HSS index variation between the groups (P < 0.01). Acupotomy group and EA group showed big difference in pain index before and after treatment (P < 0.01). Apparent difference also existed in the comparison among groups (P < 0.01). Both acupotomy group and EA group had apparent changes in infrared thermal imaging detection before and after the treatment (P < 0. 01). CONCLUSION: Acupotomy and EA both have significant effects in KOA treatment; the former is better than the latter in relieving pain and improving knee functions. © 2016 JTCM.This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Abstract

Key words: Osteoarthritis, knee; Acupotomy; Infrared thermal imaging; Ultrasound-guided; Randomized controlled trail

OBJECTIVE: To investigate the effect of acupotomy on knee osteoarthritis (KOA), compared to electro-acupuncture (EA).

INTRODUCTION

METHODS: Sixty KOA patients were randomly divided into 2 groups: ultrasound-guided acupotomy group and EA group; each had 3 weeks' therapy. After the treatment, by contrast before and after therapy, by comparing curative effects among groups, we looked into disease improvement degree through activities of daily living score (ADL), hospital for special surgery index (HSS), visual analogue scales score (VAS) and knee joint's infrared thermal imaging detection .

Knee osteoarthritis (KOA) is a chronic arthritis caused by multiple reasons triggering joint degeneration, articular cartilage damage and para-knee articular soft tissues degeneration. Patients may suffer from joint pain, swelling, deformity, dysfunction and other symptoms.1 In the past decades, acupotomy dissolution had been widely used in the treatment of KOA and had achieved sound curative effects in relieving pain and improving joint functions. However, compared with other methods, there hasn't been an objective or rigorous controlled study into its advantages, features and principles. On the other hand, the safety of acupotomy is often questioned because it's a closed surgery which has

RESULTS: Graded by ADL, the excellent rate in acupotomy group was much higher than EA group; both acupotomy group and EA group had obvious JTCM | www. journaltcm. com

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strict requirements of the operators. Operators' perception of the disease and their familiarity of anatomical positions are essential to the curative effect as well as operation security. All of above make it difficult to assess acupotomy's application value in treating KOA. In regard of this, our experiment was aimed to investigate the effect of ultrasound-guided acupotomy in the treatment of KOA, compared with elector-acupuncture.

Products Co., Ltd., Beijing, China); Pulsing electrotherapeutic apparatus: with the size KWD-808 (Changzhou Wujin Great Wall Medical Instrument Co., Ltd., Changzhou, China); Color Doppler imagining (CDI): with the size Sequoia 512 (Siemens, Berlin, Germany); Medical infrared imaging system: size ATIR-M301B (Chongqing Weilian Technology Co., Ltd., Chongqing, China) Grouping method This was an open trial. We made random number table and random assignment card by CHISS program, then the doctor numbered the cases by time order, grouped them randomly according to the allocated number. All the index were assessed independently by specialized doctors (Table 1).

MATERIALS AND METHODS Materials All the 60 KOA patients were diagnosed by General Hospital of PLA. Of them, 45 were recruited in this research (35 females and 10 males). Their ages were ranged from 42 to 69 years with the average of 57.3 years. All had 2-15 years of disease course with 7 years' average. There were 30 unilateral knee joint incident cases and 15 cases of double knees. In total, we had 60 knee joints, with 24 left knee joints and 36 right knee joints. All patients had signed informed consent before participating in the study. This research was approved by Medical Ethics Committee of General Hospital of PLA.

Table 1 Clinical characteristics of acupotomy group and EA control group ( xˉ ± s) X-ray grade

n

Acupotomy

30

7.43±2.71 58.22±4.87 2.78±0.31

Electro-acupuncture

30

7.28±2.41 60.12±4.23 2.69±0.26

Notes: acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks, Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks.

Diagnostic criteria (a) Frequent gonyalgia in the past months; (b) osteophyte detected by bone X-ray; (c) joint fluid inspection conforms to KOA symptoms; (d) 40 years old or over; (e) less than 30 min' morning stiffness; (f ) having bone crepitus. The patient having 1 + 2 or 1 + 3 + 5 + 6 or 1 + 4 + 5 + 6 symptoms, could be diagnosed as KOA. According to X-ray inspection, we classified the results by Kellgren Grading Standard for KOA X-ray film.2

Therapeutic method In Acupotomy group, we followed the operating procedures of The Principles of acupotomology.3 EA control group: we conducted the treatment by common acupoint positioning method. Basic operating regulations for ultrasound-guided acupotomy: (a) finding the lesion location from physical examination and locating the A-shi point to make identification. (b) Conducting ultrasound examination, compare the physical examination results and confirm the operating points with identification. (c) Examining the operating positions by ultrasound for lesion areas, divide the knee joint into front area (supine position, put pad under the popliteal space), interior leaning area (supine position, leaning to the infected knee slightly), exterior leaning area (side-lying position of the opposite infected knee) and the back area (supine position), then inspect them in sequence.4 We stained the diseased area by gentian violet and scanned primarily on positive reaction points. Based on ultrasound inspection, physical examination and other image data, we determine the lesions nature and operating positions. (d) Patients in supine position; we elevated the infected knee slightly with pillow to the extent when the patient felt relaxed and comfortable. We took no more than 5 five points each time according to previous fixed points, staining them by gentian violet. Choosing needle-knife (Hanzhang type 1, No. 4) to give routine disinfection with 0.5% iodophor on the selective operation skin, the operators wore sterile gloves with the skin partially iodophor disinfectant, then lift

Inclusion criteria (a) The case met the above diagnosis standards with the grading level in Ⅱ and Ⅲ; (b) no other treatment involved during 2 weeks before the grouping; (c) all patients voluntarily participated and would like to sign informed consent; (d) the patients had clear understanding about the significance of acupotomy research; (e) the disease course exceeded one year. Exclusion criteria (a) The patients did not meet the diagnostic criteria or inclusive criteria; (b) those failed to complete the therapy or interrupt the treatment or had other therapy at the same time; (c) those who have serious disease or mentally disorders; (d) patients were over 80 or under 30; (e) pregnant women or lactating women. Apparatus Ultrasound coupling agent: 250 g (Beijing Dafu Medical Products Co., Ltd., Beijing, China); Ultrasound coupling agent (sterile): 40 g (Beijing Dafu Medical JTCM | www. journaltcm. com

Disease HSS grading course results

Group

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RESULTS

sterile drapes, extract 2% Lidocaine to retreating inject on all therapeutic positions, each point with 1ml dose. Partially smearing sterile coupling agent, we packed the ultrasonic probe with isolation cover and put it in proper place. Penetrating the skin by routine needle-inserting method, we observed needle running in subcutaneous tissue and once it reaches the lesion area, we release it and stop bleeding by pressing partially after pulling out. Pressing the piercing points for 3 min after removing the needles, we covered the area by sterile material to keep it dry and clean, avoiding overloaded knee joint. Attention: when needle reached the fixed points, if the ultrasound probe impeded its operation, we could remove it from the skin surface. (e) Kept the operating area dry and clean for 3 days after the treatment in case of infection or overloaded knee joint, proper excise to quadriceps femoris and perform reexamination one week later. Basic operating regulations for EA treatment: inserted points of Neixiyan (EX-LE 4), Xiyan (EX-LE 5), Xuehai (SP 10), Liangqiu (ST 34), Yanglingquan (GB 34), Yinlingquan (SP 9) and pain point, and connecting electric acupuncture apparatus (KW-808) after the needle created the desired sensation and operated with continuous-wave for 30 min in 2-4 HZ, to the degree which the patients could withstand. This treatment was conducted once every day, lasting for 3 weeks with 2 days' rest after each 5 days' consecutive therapies.

All the cases completed the whole therapy process (Figure 1) with no suspension or abandon. (a) KOA ADL Scoring Method by Japanese Orthopedic Association (JOA). We scored both groups by JOA suggested ADL scoring method, illustrating the improvement rate in acupotomy was higher than EA group (Table 2). The acupotomy had higher improvement rate. (b) Improved HSS (hospital for special surgery) KOA scoring method. A significant difference was found in HSS index between the two both groups (P < 0.01; Table 3). (c) VAS scores. VAS results had significant difference in both groups (P < 0.01; Table 4), Comparing these two groups, the difference also indicated that acupotomy had better effect than EA in relieving the pain of KOA. (d) Infrared thermograph. Took navel as the base point, we divided the measuring area into patellar area, superior patella (2 cm superior border of patella), inferior patella (4 cm inferior border of patellar), interior leaning area, exterior leaning area and the back area. The average temperature in each area was in contrast with the navel to get the temperature differences. Next we analyzed the temperature difference before and after the treatment by average temperatures' mean and standard deviation. We found that both groups had apparent changes in temperature (Table 5), which dropped largely from the base point (P < 0.01). The difference in temperature showed that both therapies could improve partial venous stasis while remained no distinction between two groups' results.

Measurement We examined following indexes one week before and after the treatment respectively: (a) KOA ADL Scoring Method by Japanese Orthopedic Association (JOA). Indicating the results by rate of improvement in symptom (RIS), our calculation method is RIS = [(postoperative score － preoperative score)/ (55 － preoperative score)] × 100%, if RIS > 75% the result is excellent, 50%-74%, good, 25%-49%, moderate and if RIS < 24%, bad. (b) Improved HSS (hospital for special surgery) KOA Scoring Method5. Observational index and calculation method are: with total 100 points, pain accounts for 30 points; function, 22 points; mobility, 18 points; muscle strength, 10 points; flexion deformity, 10 points and steadiness, 10 points. The higher the score is the better function of the joint. (c) VAS (visual analogue scales) was used to measure pain (0-10 scales): 0 no pain; 1-3 slight pain; 4-6 moderate pain; 7-9 serious pain; and 10 extreme pain. (d) Infrared thermograph. Infrared thermograph was used to detect local temperature changes in KOA area.

DISCUSSION Acupotomology visualization According to our research, ultrasound-guided acupotomy has obvious advantages in treating KOA wit following manifestations: (a)12 It can have accurate positioning though careful physical examinations and imageological examinations are necessary before the treatment, we could locate the lesion positions and the needle's operating places no longer by experience but by the ultrasound guidance. Under the ultrasound directions, we could easily observe the lesion positions and the needle's operating conditions. KOA, for example, X-ray image could detect spur or other high stress points, but the image is two dimensional which means that doctors still cannot locate the exact operating area. Physical examinations could help find the tenderness points, but the concrete level of which is still unknown. In spite of all above, ultrasound could locate the positions accurately and still detect the positions and levels in which the needle-knife reaches. (b) More accurate diagnosis. As an important diagnosis technolo-

Statistical analysis We analyzed the data with SPSS 12.0 (SPSS Institute, Chicago, IL, USA) and measurement data were expressed as ( xˉ ± s). T-test was performed for the comparison before and after the therapy. P < 0.05 was the statistical significant level. JTCM | www. journaltcm. com

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Outpatients (n = 60) Identify the exclusion criteria. （n = 60） Patients who meet the inclusion criteria (n = 60)

Dismiss patients who do not meet the inclusion criteria (n = 0)

Discuss with the patients and get the informed consents (n = 60) Filter out those who don't want to be observed (n = 0)

Conducted ADL scoring, HSS scoring, VAS scoring and infrared thermal imaging detection (n = 60)

EA group (n = 30)

Acupotomy group (n = 30)

After 3 weeks' treatment, we measure KOA conditions by ADL scoring, HSS scoring, VAS scoring and infrared thermal imaging detection once again (n = 60) Statistical analysis and draw conclusions (n = 60) Figure 1 Flow chart of the study Acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks; Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks. VAS: visual analogue scales, HSS: hospital for special surgery. ADL: daily life scale; JOA: Japanese Orthopedic Association.

injury which physical examinations and X-ray couldn't find.13 The common imageological diagnosis often use X-ray in examining KOA whereas hydrops articuli, cartilage or meniscus injury cannot be found by X-ray. Compared with expensive MRI examination, ultrasound is clearly more superior. (c) More save and environmental. Compared with X-ray and CT, ultrasound has no radioactive harm to operators and patients, which is a very important factor. Besides, the probe is small and flexible which can detect the position from different angles and directions, thus enabling the operator to find appropriate route to insert the needle and observe the running of the needle, avoiding vital vessels, organs and nerves.

Table 2 Comparison of ADL in acupotomy group and EA control group before and after treatment Group

n Excellent Good

OK

Bad

Total effective rate (%)

Acupotomy 30

4

17

6

3

90.00

EA

2

15

11

2

93.33a

30

Notes: acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks, Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks. compared with the acupotomy group, aP > 0.05. ADL: daily life scale; JOA: Japanese Orthopedic Association; EA: electro-acupuncture.

gy, ultrasound has apparent advantages in treating musculoskeletal disorders in that it could detect soft tissues

Table 3 HSS results' comparison in acupotomy group and EA control group before and after treatment ( xˉ ± s) Group

Before treatment

After treatment

Scoring difference before and after treatment

Acupotomy

58±5

86±5

14±5

EA

60±4

77±6b

a

9±5c

Notes: acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks, Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks. compared with score before the treatment, showing aT = 21.08, aP = 0.00; compared with scores before the treatment, bT = 12.61,bP = 0.00; compared with acupotomy group, indicating cT = 3.99,cP = 0.0002. EA: electro-acupuncture. HSS: hospital for special surgery. JTCM | www. journaltcm. com

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and the knee peripheral area's temperature dropped down.

Table 4 Comparison of VAS scores in acupotomy group and EA control group before and after treatment ( xˉ ± s) Group

Before treatment After treatment Difference-value

Acupotomy

5.1±1.1

2.1±1.7a

3.0±1.4

EA

5.1±1.5

3.1±1.2b

2.0±1.4c

Pathways and advantages of acupotomy in treating KOA From the acu-point selecting method of acupotomy therapy, we mainly choose A-shi point, tendon ligament attached points, bone spurs and etc, which is different from electric acupuncture. As for acupuncture or EA, we usually select A-shi point, Neixiyan (EX-LE 4), Xiyan (EX-LE 5), Xuehai (SP 10), Liangqiu (ST 34), Yanglingquan (GB 34). This indicates that former method is based on dissection, choosing the high stress points around articular capsule while the later one is based on meridian by following the principle "dredging the meridian and regulating Qi and blood", treating in a way which goes like "pain is disruption while smoothness means no pain". From the aspect of curative effects, the acupotomy exceled EA in relieving pain and improving functions in our research while both groups had no difference in thermal image detection. We deduce that there are following reasons in this regard, (a) acupotomy has more pertinence with greater release, which is quick to relieve muscle spasm, thus improving venous stasis, reducing intraosseous pressure and promoting functions. EA could also release muscle spasm by multiple mild stimulations whereas the releasing effect is not as strong as that of acupotomy. (b) EA's effects are not only in releasing muscle spasm but also in promoting blood circulation and improving inflammatory by regular muscular contraction. In this way, EA has better effect for join thydrops and joint swelling. So both methods show no difference in thermal imaging. However, acupotomy has no similar effect. As a kind of lysis, it will trigger new inflammation during the therapy and the thermal images will show high temperature in inflammatory area, explaining why they had no distinction in infrared thermal image examination In conclusion, both acupotomy and EA have sound short-term effect in treating KOA and acupotomy is superior to EA in relieving pain and improving joint functions. Ultrasound-guided acupotomy is worth further investigation in clinical practice.

Notes: acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks, Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks. compared with scores before the treatment, aT = 8.01, a P = 0.00. compared with scores before the treatment, bT = 6.46, b P = 0.00; compared with acupotomy group, cT = 2.806, cP = 0.0067. VAS: visual analogue scales; EA: electro-acupuncture.

Infrared thermal imagings It has been some time when infrared thermal image was first used in our medical research. In mid 70 s, the first thermal infrared imager was successfully built for clinical treatment.14 Since then, medical researchers have done a lot in this area. Human body is a complicated heat source with thermal graphs varying from different parts. Zhao15, Li16 and other scientists have observed thermal image distribution laws of vertebral region as well as head and neck region in normal people. Meng17 and others discovered that healthy young men's thermal images of double-limbs are bilateral symmetry; the shank's temperature is lower than thigh by 0.4 ℃ and the temperature in patellar area is the lowest. Zheng18 analyzed the temperature changes in KOA peripheral skin before and after the compression tourniquet and found that the knee center had the highest temperature and this became even higher after compression with much more pain. Compared with corresponding position of normal knee joint, the infected one was higher by 0.3-1.0 ℃ , showing the significant difference. The distinction got more obvious after the compression. We believe that serious venous stasis in KOA joints cause above manifestations in thermal images. This means that infrared thermal image could be used as a supplementary method to detect venous stasis of OA. Chen19 holds that pressurized tourniquet may trigger gonatalgia or aggravated pain; besides, medullo-puncture needle and intra medullary pressure measuring instrument calculate rising intraosseous pressure in distal femur and proximal tibia. All above show that infrared thermal image could detect the conditions of venous stasis, which reflect the changes of intraosseous pressure indirectly. In our experiment, after acupotomy and acupuncture treatment, the patients' symptoms have been improved

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Table 5 Comparison of infrared thermal images in acupotomy group and EA control group before and after treatment ( xˉ ± s) Pre-therapy temperature difference

Post-therapy temperature difference

Distinction in before and after temperature difference

Acupotomy

0.81±0.21

0.32±0.12a

0.49±0.16

EA

0.78±0.25

0.33±0.14b

0.45±0.19c

Group

Notes: acupotomy group was treated with ultrasound-guided acupotomy 3 times for 3 weeks, Electro-acupuncture (EA) group was treated with electro-acupuncture 15 times for 3 weeks. compared with scores before treatment, aT = 17.12, aP = 0.00; compared with scores before the treatment, bT = 8.60, bP = 0.00, compared with acupotomy group, cT = 0.88, cP = 0.38. JTCM | www. journaltcm. com

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