Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial
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Abstract Background: The loss of life ability of patients after stroke is mostly caused by the dysfunction of upper limbs, especially hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation showed that fascial point needling could effectively alleviate hand spasm immediately after stroke, but further evidence from large sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial point acupuncture on hand spasm after stroke. Methods/design: This multicenter randomized controlled trial will compare the efficacy of fascial point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial point acupuncture or the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indexes are the remission of hand spasm and the duration of spasm remission. The second evaluation indexes are the hand function of affected limbs and the ability of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. Discussion: Our aim is to evaluate the efficacy of fascial point acupuncture in relieving hand spasm after stroke. The results will provide more evidences for the clinical application of this therapy in the future. Trial registration: The trial has been registered at the Chinese Clinical Trial Registry（ChiCTR）on April 9, 2019. Registration number: ChiCTR1900022379 Keywords: Fascia points, Acupuncture, Spasm, StrokeKeywords:
Stroke
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Manual therapy
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Background: Acupuncture is a popular complementary and alternative treatment for chronic back pain.Recent European trials suggest similar short-term benefits from real and sham acupuncture needling.This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.Methods: A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care.Ten treatments were provided over 7 weeks by experienced acupuncturists.The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale).Outcomes were assessed at baseline and after 8, 26, and 52 weeks.Results: At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (PϽ.001).Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P Ͻ .001).Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P Ͻ .001).After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P =.02) but not in symptoms (P Ͼ .05).Conclusions: Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits.These findings raise questions about acupuncture's purported mechanisms of action.It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.
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Abundant experiences have already been accumulated in treatment of stroke with acupuncture.Development of rehabilitation theory also brings unprecedented opportunity and challenge to acupuncture.Combined with the modern rehabilitation theory and practice,it is very helpful to deepen the understanding on treatment of acupuncture for cerebral apoplexy and enhance the therapeutic effect in clinic by studying the mechanism of acupuncture treatment,opportunity of intervention,selection of acupoints,needling manipulations and quantity of stimulations etc.Through analysis on the necessity and the way of combination of acupuncture and modern rehabilitation,it is concluded that rehabilitation evaluation,rehabilitation phases and obstacle analysis should be taken as references by acupuncturists to reinforce the therapeutic effect and creditability of acupuncture treatment on cerebral apoplexy.
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Acupuncture therapy
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Abundant experiences have already been accumulated in treatment of stroke with acupuncture. Development of rehabilitation theory also brings unprecedented opportunity and challenge to acupuncture. Combined with the modern rehabilitation theory and practice, it is very helpful to deepen the understanding on treatment of acupuncture for cerebral apoplexy and enhance the therapeutic effect in clinic by studying the mechanism of acupuncture treatment, opportunity of intervention, selection of acupoints, needling manipulations and quantity of stimulations etc. Through analysis on the necessity and the way of combination of acupuncture and modern rehabilitation, it is concluded that rehabilitation evaluation, rehabilitation phases and obstacle analysis should be taken as references by acupuncturists to reinforce the therapeutic effect and creditability of acupuncture treatment on cerebral apoplexy.
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Acupuncture therapy
Stroke
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Objective: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. Design: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). Outcome measures: Participating trial physicians and interventions. Results: Forty-five (45) physicians specializing in acupuncture (mean age 44 ± 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140–2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 ± 4.2 in the acupuncture group compared to 12.3 ± 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. Conclusions: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.
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Introduction . Acupuncture was recently shown to be effective in the treatment of knee osteoarthritis. However, controversy persists whether the observed effects are specific to acupuncture or merely nonspecific consequences of needling. Therefore, the objective of this study is to determine the efficacy of different acupuncture treatment modalities. Materials and Methods . We compared between three different forms of acupuncture in a prospective randomised trial with a novel double-blinded study design. One-hundred and sixteen patients aged from 35 to 82 with osteoarthritis of the knee were enrolled in three study centres. Interventions were individualised classical/ modern semistandardised acupuncture and non-specific needling. Blinded outcome assessment comprised knee flexibility and changes in pain according to the WOMAC score. Results and Discussion . Improvement in knee flexibility was significantly higher after classical Chinese acupuncture (10.3 degrees; 95% CI 8.9 to 11.7) as compared to modern acupuncture (4.7 degrees; 3.6 to 5.8). All methods achieved pain relief, with a patient response rate of 48 percent for non-specific needling, 64 percent for modern acupuncture, and 73 percent for classical acupuncture. Conclusion . This trial establishes a novel study design enabling double blinding in acupuncture studies. The data suggest a specific effect of acupuncture in knee mobility and both non-specific and specific effects of needling in pain relief.
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목적 : 본 연구는 퇴행성 슬관절염 환자의 통증을 줄이고 증상을 개선하는데 있어 현재 침구임상에서 활용되고 있는 온침이 침보다 더욱 유효한지를 알아보기 위하여 임상연구로 시행되었다. 방법 : 총 76명의 퇴행성 슬관절염 지원자가 연구에 참가하였으며, 이들 모두는 선정기준과 제외기준에 의하여 선발되었고 최종적으로 임상연구를 마친 지원자는 66명이었다. 지원자들은 무작위로 온침군과 침군 중에 할당이 되었다. 실험군(온침)에 속한 38명은 온침시술을, 대조군(침)에 속한 38명은 침시술을 받았으며, 8주 동안 총 16회의 시술을 환측의 무릎에 시행하였다. 주된 평가척도는 Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)이었고, 부수적 평가척도는 physical health score based on the 36-Item Short-Form Health Survey(SF-36), Patient Global Assessment이었다. 결과 : 실험군이 대조군에 비해서 WOMAC의 pain, function, total score와 Patient Global Assessment에서 월등한 감소를 나타내었으나 SF-36에서는 유의한 변화가 없었다. 결론 : 이번 연구의 결과를 통해 온침이 침에 비하여 퇴행성 슬관절염 환자의 통증 감소와 기능개선에 유의성있게 효과가 있음을 확인하였다. Objectives : The aim of this study was to investigate whether warm-needling is more effective than acupuncture in relieving the pain and improving the symptoms of knee osteoarthritis(OA). Methods : 76 volunteers with knee OA participated in the study. The subjects were randomly assigned to one of two groups. One group received warm-needling(n=38), while the other group received acupuncture(n=38). Sixteen sessions of warm-needling or acupuncture were conducted on the pain region of each problematic knee over a period of 8 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores, physical health score based on the 36-Item Short-Form Health Survey(SF-36) and the Global Assessment(PGA) was measured. Results : Compared to the acupuncture group, the warm-needling group showed a significant decrease in pain, function, and total WOMAC scores according to the Mann-Whitney U-test. The PGA scores of the warm-needling group also showed a significant improvement compared to the acupuncture group. Conclusions : Warm-needling showed a greater pain relief effect on knee OA compared to the acupuncture group. These findings suggest that warm-needling may be a promising alternative therapy for treating knee OA.
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Acupuncture is a popular non-pharmacological modality for treating musculoskeletal pain. Physiotherapists are one of the largest groups of acupuncture providers within the NHS, and they commonly use it alongside advice and exercise. Conclusive evidence of acupuncture's clinical effectiveness and its superiority over sham interventions is lacking. The Arthritis Research Campaign (arc) has funded this randomised sham-controlled trial which addresses three important questions. Firstly, we will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain. Secondly, we will evaluate sham acupuncture in the same way. Thirdly, we will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome. We will thus investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties. This randomised clinical trial will recruit 350 participants with knee pain to three intervention arms. It is based in 43 community physiotherapy departments in 21 NHS Trusts in the West Midlands and Cheshire regions in England. Patients aged 50 years and over with knee pain will be recruited. Outcome data will be collected by self-complete questionnaires before randomisation, and 6 weeks, 6 months and 12 months after randomisation and by telephone interview 2 weeks after treatment commences. The questionnaires collect demographic details as well as information on knee-related pain, movement and function, pain intensity and affect, main functional problem, illness perceptions, self-efficacy, treatment preference and expectations, general health and quality of life. Participants are randomised to receive a package of advice and exercise; or this package plus real acupuncture; or this package plus sham acupuncture. Treatment details are being collected on a standard proforma. Interventions are delivered by experienced physiotherapists who have all received training in acupuncture to recognised national standards. The primary analysis will investigate the main treatment effects of real or sham acupuncture as an adjunct to advice and exercise. This paper presents detail on the rationale, design, methods, and operational aspects of the trial.
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Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain. An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback. Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible protocol for use in a definitive multicentre randomized controlled trial. ClinicalTrials.gov: NCT02126436 .
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