International research project to devise a protocol to test the effectiveness of acupuncture on painful shoulder. Acupuncture for chronic shoulder pain. An experimental study with attention to the role of placebo and hypnotic susceptibility. Clinical study comparing acupuncture, physiotherapy, injection and oral anti-inflammatory therapy in shoulder-cuff lesions. Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis. Acupuncture for frozen shoulder. Controlled trial of Japanese acupuncture for chronic myofascial neck pain: assessment of specific and nonspecific effects of treatment.
To describe in detail the questions and deliberations leading to the development of a methodologically rigorous protocol to test the effectiveness of acupuncture on painful shoulder.
                Randomized controlled trial using three groups, including one control group.
                A hospital in the north of Italy treating at least 8-10 painful shoulders a day, with physician/acupuncturists, physiotherapists, and assessors available to participate in the study.
                Sixty patients with monolateral painful shoulder. A list of exclusion criteria is given.
                Acupuncture + mobilization; mobilization alone (control); ear acupuncture + mobilization.
                Severity of pain, scored on a visual analogue scale (VAS) and on the McGill Pain Questionnaire and restriction of range of motion (ROM) of the shoulder joint. Voluntary use of pain medication, Tenoxicam 20 mg, was added to the protocol.
                The research team developed a protocol and methodology that avoids the common flaws and difficulties of previous clinical trials on acupuncture.
                Physicians and acupuncture specialists will benefit from the advice and support of a project group consisting of experienced clinicians, researchers, and statisticians when designing and preparing clinical trials on acupuncture and other complementary and alternative therapies. One half of 42 subjects treated for painful shoulders received classic acupuncture, and one half received a placebo in which the needles did not penetrate the skin. Half of each of these groups was treated in a positive setting to encourage the subject, and half in a negative setting designed to keep encouragement at a minimum. All patients were independently rated for susceptibility to hypnosis. Although range of motion did not improve, the majority of patients reported significant improvement in shoulder discomfort to a blind evaluator after treatment; placebo and acupuncture groups did not differ in this respect, however. The positive and negative settings did not affect treatment outcome. In all groups, those who were not rated as highly susceptible to hypnosis tended to fail to achieve the highest levels of relief, but such differences were not statistically significant. In a single-blind trial, five treatments for painful stiff shoulder were compared for a 4-week assessment period in 60 patients. The treatments were acupuncture, steroid injection with placebo and with active tolmetin sodium, physiotherapy in the form of ultrasound and 'placebo' physiotherapy with placebo tolmetin sodium. Objective assessment was gained by use of goniometer readings to monitor shoulder abduction. Pain was measured by visual analogue scales and by a 4-point scale. Comparative assessment was also recorded and at the end of the study a success or failure was recorded for each patient's treatment. With very few exceptions all patients improved markedly, both in terms of the subjective and objective parameters. No differences between the treatments were detected. The incidence and severity of side-effects was low. It is suggested that the results show that the painful stiff shoulder may be a self-limiting condition and that any beneficial effect was really due to natural recovery. This is an important consideration because patients do not always receive immediate attention when referred to an out-patient department and the use of physiotherapy and acupuncture in such cases, perhaps, should be critically examined. 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. This randomised controlled trial was undertaken to evaluate the effectiveness of acupuncture as a treatment for frozen shoulder. Thirty-five patients with a diagnosis of frozen shoulder were randomly allocated to an exercise group or an exercise plus acupuncture group and treated for a period of 6 weeks. Functional mobility, power, and pain were assessed by a blinded assessor using the Constant Shoulder Assessment, at baseline, 6 weeks and 20 weeks. Analysis was based on the intention-to-treat principle. Compared with the exercise group, the exercise plus acupuncture group experienced significantly greater improvement with treatment. Improvements in scores by 39.8% (standard deviation, 27.1) and 76.4% (55.0) were seen for the exercise and the exercise plus acupuncture groups, respectively at 6 weeks (P=0.048), and were sustained at the 20-week re-assessment (40.3% [26.7] and 77.2% [54.0], respectively; P=0.025). We conclude that the combination of acupuncture with shoulder exercise may offer effective treatment for frozen shoulder. This article examines the specific and nonspecific effects of Japanese acupuncture on chronic myofascial neck pain in a randomized single-blind trial.
                Forty-six patients were randomly assigned to receive relevant acupuncture, irrelevant acupuncture, or no-acupuncture control treatment consisting of nonsteroidal anti-inflammatory medication. The two acupuncture groups underwent comparable light shallow needling. The irrelevant acupuncture group received acupuncture at specific sites not relevant for cervical pain.
                The study measures included the McGill Pain Questionnaire-Short Form (SF-MPQ), the Short-Form Health Survey (SF-36), the Symptom Checklist 90-Revised (SCL-90-R), medication diary, and physiologic measures. The factors examined as predictors of outcome pain ratings were experience with, beliefs about, and knowledge of acupuncture before treatment; perceived efficacy, credibility, and logic of acupuncture; perceived competence of the acupuncturist; and painfulness of acupuncture.
                No differences were found among the three groups at baseline, except that the relevant acupuncture group reported having had more previous acupuncture treatments. No significant differences in terms of perceived credibility or perceived effectiveness of treatment were found between the two acupuncture groups. The relevant acupuncture group had significantly greater pre-/posttreatment differences in pain than the irrelevant acupuncture and control groups (p < .05). The nonspecific effects of confidence in the acupuncturist, willingness to try any treatment, mood, and physiologic effect of needling were not predictive of treatment outcome, whereas confidence in the treatment and past experiences with acupuncture did correlate significantly with a decrease in pain.
                Relevant acupuncture with heat contributes to modest pain reduction in persons with myofascial neck pain. Previous experience with and confidence in treatment help to predict benefit. Measurement of nonspecific effects of alternative therapy is recommended in future clinical trials.
Due to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to support or refute the use of acupuncture for shoulder pain although there may be short-term benefit with respect to pain and function. There is a need for further well designed clinical trials.