Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. [Effect of needle acupuncture on pain perception and functional impairment of patients with coxarthrosis]. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Acupuncture for the treatment of pain of osteoarthritic knees. Randomized controlled trial of acupuncture versus sham acupuncture in autism spectrum disorder. Acupuncture for irritable bowel syndrome: a blinded placebo-controlled trial. Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis. Temporary pain relief using transcranial electrotherapy stimulation: results of a randomized, double-blind pilot study. Extracorporeal shock wave therapy for lateral epicondylitis--a double blind randomised controlled trial. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. The effect of acupuncture on patients with rheumatoid arthritis: a randomized, placebo-controlled cross-over study. Does acupuncture improve the orthopedic management of chronic low back pain--a randomized, blinded, controlled trial with 3 months follow up. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Using acupuncture to treat depression: a feasibility study. Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized, double-blind, sham-controlled crossover trial.
Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal.
                To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee.
                Randomized, controlled trial.
                Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility.
                570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years).
                23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks.
                Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36).
                Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02).
                At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis.
                Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups. The effectiveness of acupuncture treatment in patients with osteoarthritis of the hip was tested.
                This is a prospective, randomized, controlled patient and examiner blinded clinical trial.
                The study was performed at a university department for physical medicine and rehabilitation. Sixty-seven patients were separated into two treatment groups.
                Group 1 (treatment) had traditional needle placement and manipulation, whereas in group 2 (control) needles were placed away from classic positions and not manipulated. In both groups needles were placed within the L2 to L5 dermatomes. Endpoints were pain (VAS), functional impairment (hip score), activity of daily living (ADL) and overall satisfaction before treatment, 2 weeks and 2 months post-intervention.
                For all endpoints there was a significant improvement in both groups 2 weeks and 2 months following treatment versus baseline, but no significant difference between the two treatment groups.
                We conclude from these results that needle placement in the area of the affected hip by itself improves symptoms of osteoarthritis. It appears to be less important to follow the rules of traditional acupuncture techniques. Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal.
                To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee.
                Randomized, controlled trial.
                315 primary care practices staffed by 320 practitioners with at least 2 years' experience in acupuncture.
                1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren-Lawrence score of 2 or 3). Interventions: Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful.
                Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment.
                Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and 29.1% for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]).
                There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups.
                Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles. The purpose of this study was to determine whether acupuncture was more effective than sham acupuncture in the reduction of pain in persons with osteoarthritis (OA) of the knee.
                Forty subjects (20 men, 20 women) with radiographic evidence of OA of the knee were stratified by gender and randomly assigned to either the experimental (real acupuncture) or control (sham acupuncture) groups. Subjects were treated three times per week for 3 weeks and evaluated at three test sessions. Outcome measures were: 1) the Pain Rating Index of the McGill Pain Questionnaire, 2) the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and 3) pain threshold at four sites at the knee.
                The analyses of variance showed that both real and sham acupuncture significantly reduced pain, stiffness, and physical disability in the OA knee, but that there were no significant differences between groups.
                Acupuncture is not more effective than sham acupuncture in the treatment of OA pain. We aim to study the efficacy of acupuncture versus sham acupuncture in children with autism spectrum disorder.
                A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to the treatment group with tongue acupuncture (40 sessions over 8 weeks) or the control group (sham tongue acupuncture to nonacupoints in the tongue).
                There was improvement in both the treatment and control groups in all assessed measures but more so in the treatment than in the control group: (1) eye-hand coordination, performance, and practical reasoning of Griffiths Mental Developmental Scale; (2) sensory-motor, social, affectual, language, and total score of Ritvo-Freeman Real Life Scale; (3) Comprehension Language age in the Reynell Language Developmental Scale; and (4) Total Score and Mental Age in Symbolic Play Test. The only statistically significant improvement in the treatment as compared to the control group was seen in self-care and cognition domains of the Functional Independence Measure for children.
                We had demonstrated that a short course of acupuncture had efficacy in improving various developmental and behavioral aspects of children with autism. The long-term efficacy in functional gain needs to be further explored. Irritable bowel syndrome (IBS) is a common disorder and many patients fail to find adequate relief from conventional therapies for their symptoms. This study tests the claim that acupuncture is effective for a majority of these patients.
                A prospective, blinded, sham acupuncture-controlled trial of traditional Chinese acupuncture was performed at a single postgraduate teaching hospital in Europe. Sixty patients with well-established IBS were recruited. The blinded comparator was sham acupuncture administered by the second of two acupuncturists who alone was aware of the randomization, and who otherwise followed the prescription of the first. The primary end-point was a defined fall in the symptom score at 13 wk (by intention to treat). The prior expectation was a 30% placebo response, and a response rate of 70% from acupuncture, for which the study was adequately powered.
                Patients in treated and sham groups improved significantly during the study-mean improvement in scores being equal (minus 1.9) and significant for both (P<0.05; one-tailed t test). There was a small numeric but non-significant difference between the response rate in patients receiving acupuncture (40.7%) and sham treatment (31.2%). Several secondary end-points marginally favored active treatment, but an improved symptom score of any degree of magnitude occurred more often with sham therapy (65.6% vs 59.2%). For no criterion was statistical significance approached.
                Traditional Chinese acupuncture is relatively ineffective in IBS in the European hospital setting, and the magnitude of any effect appears insufficient to warrant investment in acupuncture services. Acupuncture has gained increasing attention in the treatment of chronic pain. The lack of a satisfying placebo method has made it impossible to show whether needling is an important part of the method or whether the improvement felt by the patient is due to the therapeutic setting and psychological phenomena. Also, the effectiveness of acupuncture has not been demonstrated sufficiently. We treated 52 sportsmen with rotator cuff tendinitis in a randomised single-blind clinical trial using a new placebo-needle as control. Patients were treated for 4 weeks. The primary endpoint of the trial was the change in the modified Constant-Murley-score from the baseline. Assessment of the treatment outcome was made by experienced orthopaedists not informed of the treatment allocation. Acupuncture with penetration of the skin was shown to be more effective than a similar therapeutic setting with placebo needling in the treatment of pain. The acupuncture-group improved 19.2 Constant-Murley-score points (SD 16.1, range from -13 to 50), the control-group improved 8.37 points (SD 14.56, range from -20 to 41), (P=0.014; C.I. 2.3;19.4). This study showed that needling is an important part of the acupuncture effect in the treatment of chronic shoulder pain in athletes. No conclusions can be derived from this study concerning the importance of choosing points and the rules of Traditional Chinese Medicine. Using the new placebo method as control for other ailments could improve the evidence of specific acupuncture effects beyond pain treatment. Results of a randomized, double-blind pilot study indicate that transcranial electrotherapy stimulation may be an effective treatment for the temporary reduction of pain in osteoarthritis patients. Presently, the predominant method for pain management is medication. One very different approach is the application of micro- to milliamp current applied to specific areas of the head, resulting in a release of endogenous opioids from pain management regions of the brain. For the pilot study, 64 subjects suffering from osteoarthritis of the knee and/or hip were enrolled. For two weeks prior, then during and after treatment, subject pain was self-assessed using the visual scale (VS). In addition, subjects were globally assessed by a physician. All subjects, device operators and physicians were blinded as to whether subjects were treated with an active or sham device. Data collected from the study indicate both a decrease in VS pain scores and a significant improvement (p = 0.05) in physician assessment in subjects treated with active devices compared to those treated with the sham device. Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach to the treatment of a number of soft tissue complaints. Whilst benefit has been demonstrated in calcific tendinitis, evidence is lacking for benefit in the management of non-calcific rotator cuff disorders.
                To perform a double-blind placebo controlled trial of moderate dose ESWT in chronic lateral epicondylitis.
                Adults with lateral epicondylitis were randomised to receive either active treatment (1500 pulses ESWT at 0.12 mJ/ mm2) or sham therapy, monthly for three months. All were assessed before each treatment and one month after completion of therapy. Outcome measures consisted of visual analogue scores for pain in the day and at night.
                Seventy-five subjects participated and there were no significant differences between the two groups at baseline. The mean duration of symptoms was 15.9 and 12 months in the ESWT and sham groups, respectively. Both groups showed significant improvements from two months. No significant difference existed between the groups with respect to the degrees of change in pain scores over the study period. In the ESWT group the mean (SD, range) pain score was 73.4 (14.5, 38-99) at baseline and 47.9 (31.4, 3-100) at three months. In the sham group the mean (SD, range) pain score was 67.2 (21.7, 12-100) at baseline and 51.5 (32.5, 3-100) at three months. At three months, 50% improvement from baseline was noted in 35% of the ESWT group and 34% of the sham group with respect to pain.
                There appears to be a significant placebo effect of moderate dose ESWT in subjects with lateral epicondylitis but there is no evidence of added benefit of treatment when compared to sham therapy. To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits.
                A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb).
                At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi.
                Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA. To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life.
                Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results.
                Pain management unit in a public primary care centre in southern Spain, over a period of two years.
                97 outpatients presenting with osteoarthritis of the knee.
                Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49).
                The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme.
                88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions.
                Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee. Acupuncture is commonly used by patients with chronic painful musculoskeletal disorders. There are, however, few well-designed studies of its efficacy. This paper describes a randomized placebo-controlled cross-over design to evaluate acupuncture as a useful treatment adjunct in the management of patients with rheumatoid arthritis (RA).
                Sixty-four patients were centrally randomized from a hospital-based rheumatology out-patient clinic. Fifty-six patients were suitable for study, all were on second-line therapy and aged 18-75 yr. There had been no change in therapy for the preceding 3 months. Patients who had previous acupuncture, anticoagulation, fear of needles or infection were excluded. Single-point (Liver 3) acupuncture or placebo was given with an intervening 6 week wash-out period. The acupuncturist, patient and statistician were blinded as far as possible. The outcome measures included the inflammatory markers (erythrocyte sedimentation rate and C-reactive protein), visual analogue scale of pain, global patient assessment, 28 swollen and tender joint count, and a general health questionnaire.
                The results demonstrated no significant effect of treatment or period and no significant interaction between treatment and period for any outcome variable. No adverse effects were reported.
                Acupuncture of this type cannot be considered as a useful adjunct to therapy in patients with RA. Possible reasons why this is the case are discussed. This prospective, randomised controlled trial, with three parallel groups, patient and observer blinded for verum and sham acupuncture and a follow up of 3 months raises the question: "Does a combination of acupuncture and conservative orthopedic treatment improve conservative orthopedic treatment in chronic low back pain (LBP). 186 in-patients of a LBP rehabilitation center with a history of LBP >or=6 weeks, VAS >or=50mm, and no pending compensation claims, were selected; for the three random group 4 weeks of treatment was applied. 174 patients met the protocol criteria and reported after treatment, 124 reported after 3 months follow up. Patients were assorted 4 strata: chronic LBP, <or=0.5 years, 0.5-2 years, 2-5 years, >or=5 years. Analysis was by intention to treat. Group 1 (Verum+COT) received 12 treatments of verum acupuncture and conservative orthopedic treatment (COT). Group 2 (Sham+COT) received 12 treatments of non-specific needling and COT. Group 3 (nil+COT) received COT alone. Verum- and Sham acupuncture were blinded against patient and examiner. The primary endpoints were pain reduction >or=50% on VAS 3 months after the end of the treatment protocol. Secondary endpoints were pain reduction >or=50% on VAS and treatment efficacy on a four-point box scale directly after the end of the treatment protocol and treatment efficacy after 3 months. In the whole sample a pain relief of >or=50% on VAS was reported directly after the end of treatment protocol: Verum+COT 65% (95%CI 51-77%), Sham+COT 34% (95%ci 22-49%), nil+COT 43% (95%ci 29-58%) - results are significant for Verum+COT over Sham+COT (P<or=0.02). The results after 3 months are: Verum+COT 77% (95%ci 62-88%), Sham+COT 29% (95%ci 16-46%), nil+Cot 14% (95%ci 4-30%) - effects are significant for Verum+COT over Sham+COT (P<or=0.001) and for Verum+COT over nil+COT (P<0.001). No difference was found in the mobility of the patients nor in the intake of NSAID diclofenac. Our conclusion is that acupuncture can be an important supplement of conservative orthopedic treatment in the management of chronic LBP. The purpose of this study was to investigate the efficacy of acupuncture as an adjunctive therapy to standard care for the relief of pain and dysfunction in elderly patients with osteoarthritis (OA) of the knee.
                Seventy-three patients with symptomatic OA of the knee were randomly assigned to treatment (acupuncture) or standard care (control). Analysis was performed on last score carried forward to account for patients who dropped out before completion. Patients self-scored Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne indices at baseline and at 4, 8 and 12 weeks. Patients in the control group were offered acupuncture treatment after 12 weeks. The data for these patients are pooled with those from the original acupuncture group for within-group analysis.
                Patients randomized to acupuncture improved on both WOMAC and Lequesne indices compared to those who received standard treatment alone. Significant differences on total WOMAC Scale were seen at 4 and 8 weeks. There appears to be a slight decline in effect at 4 weeks after cessation of treatment (12 weeks after first treatment). No adverse effects of acupuncture were reported.
                These data suggest that acupuncture is an effective and safe adjunctive therapy to conventional care for patients with OA of the knee. To establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group intervention, blinding of treatment, outcome measures and the acceptability of such a trial amongst participants were key factors to be addressed. The findings from this study will be used to determine the design of a phase III randomised controlled trial.
                Nineteen participants were recruited through general practices in London, UK. Participants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12 sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites considered to be unrelated to depression.
                The Beck's Depression Inventory (BDI) and the RAND 36 Item Health Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment dropout. All participants also attended a brief qualitative interview at the end of the study.
                Treatment dropout was low and there were high levels of patient enthusiasm for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than expected. The sham control method successfully maintained participant blinding to treatment and enabled the specific (or active) component of an acupuncture intervention to be isolated and its efficacy assessed. The outcome measures were sensitive enough to record changes in depressive symptoms and quality of life and are appropriate for use in a larger trial.
                This feasibility study has provided important information that can be used to guide the design and methodology of a full-randomised controlled trial. To evaluate immediate effects of two different modes of acupuncture on motion-related pain and cervical spine mobility in chronic neck pain patients compared to a sham procedure. Thirty-six patients with chronic neck pain and limited cervical spine mobility participated in a prospective, randomized, double-blind, sham-controlled crossover trial. Every patient was treated once with needle acupuncture at distant points, dry needling (DN) of local myofascial trigger points and sham laser acupuncture (Sham). Outcome measures were motion-related pain intensity (visual analogue scale, 0-100 mm) and range of motion (ROM). In addition, patients scored changes of general complaints using an 11-point verbal rating scale. Patients were assessed immediately before and after each treatment by an independent (blinded) investigator. Multivariate analysis was used to assess the effects of true acupuncture and needle site independently. For motion-related pain, use of acupuncture at non-local points reduced pain scores by about a third (11.2 mm; 95% CI 5.7, 16.7; P = 0.00006) compared to DN and sham. DN led to an estimated reduction in pain of 1.0 mm (95% CI -4.5, 6.5; P = 0.7). Use of DN slightly improved ROM by 1.7 degrees (95% CI 0.2, 3.2; P = 0.032) with use of non-local points improving ROM by an additional 1.9 degrees (95% CI 0.3, 3.4; P = 0.016). For patient assessment of change, non-local acupuncture was significantly superior both to Sham (1.7 points; 95% CI 1.0, 2.5; P = 0.0001) and DN (1.5 points; 95% CI 0.4, 2.6; P = 0.008) but there was no difference between DN and Sham (0.1 point; 95% CI -1.0, 1.2; P = 0.8). Acupuncture is superior to Sham in improving motion-related pain and ROM following a single session of treatment in chronic neck pain patients. Acupuncture at distant points improves ROM more than DN; DN was ineffective for motion-related pain.
                Copyright 2002 International Association for the Study of Pain
Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.