Abstract: There are many differing opinions on what constitutes an optimal acupuncture dose for treating any particular patient with any particular condition, and only direct comparisons of different methods in a clinical trial will provide information on which reliable decisions can be made. This article reviews the recent research into acupuncture treatment for osteoarthritis of the knee, to explore whether any aspects of treatment seem more likely to be associated with good outcome of treatment. Among four recent, high quality RCTs, one showed a much greater treatment response than the other three, and the possible factors are discussed. A recent systematic review included 13 RCTs, and this article discusses the possible explanations for differences in their outcomes. It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients' reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity - both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies.
Abstract: BACKGROUND: Pain is one of the principal symptoms for which the general public seeks medical attention, and it is frequently treated by GPs. Although acupuncture is mainly practised in the private field, it enjoys growing acceptance in the public system too, which helps bring down the high cost of its use. The aim of the present study is to evaluate the effectiveness of acupuncture and related techniques in treating non-oncological pain during nine years of activity at the Pain Treatment Unit (PTU) within the Andalusian Public Health System (Spain) in the field of primary healthcare. METHODS: Retrospective review of 5981 electronically stored case histories of patients who sought treatment for non-oncological pain and were seen at the PTU between June 1997 and July 2006. We excluded from this review those patients who had on any occasion been recruited for clinical trials at the PTU. The primary result measure applied was the success rate, defined as an improvement of least 50% on the Global Assessment Index, which is made up of five variables: pain intensity, as measured on a numerical scale of 0-10, pain frequency, consumption of analgesics, level of incapacity and sleep disorders caused by pain (the latter four variables were measured on a 5-point Likert scale of 0-4). RESULTS: The majority (84.5%) of the patients treated were women, with a mean age of 58.8 years (range 8-93), and they attended the healthcare clinic because of pain present for over three months (88.8%) and mainly affecting the lower back (58.8%). In the 5690 patients who completed treatment, the mean success rate was 79.7%, with highest rates (93%) being achieved in patients with cephalalgia. The mean reduction in pain intensity was 5.5 (SD 2.5) points amounting to 67% fall from the baseline. There was a reduction of euro7.1 in the mean weekly expenditure on analgesics per patient. From the regression model, we conclude that the patients who suffered acute or sub-acute pain presented higher success rates than did those with chronic pain (OR, 1.94; 95% CI, 1.53-2.48). CONCLUSIONS: Acupuncture seems to be effective in treating musculoskeletal pain, and presents no severe adverse events. With acupuncture treatment, the consumption of analgesic and anti-inflammatory drugs is considerably reduced.
Abstract: BACKGROUND: Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN: Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION: This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.
Abstract: Chronic neck pain is highly prevalent. To determine the efficacy and safety of acupuncture, in comparison with transcutaneous nerve stimulation-placebo (TENS-placebo) in the treatment of chronic uncomplicated neck pain, a single blind prospective study was designed, to be carried out at a Primary Healthcare Centre, with random assignment to two parallel groups and with evaluation and analysis by independent evaluators. A random assignment was made from 123 patients of the 149 initially recruited. These patients had been diagnosed with uncomplicated neck pain and experienced neck motion-related pain intensity equal to or exceeding 30 on a visual analogue scale (VAS) from 0 to 100 mm. The treatment with acupuncture was compared with TENS-placebo, applied over 5 sessions in three weeks. The primary endpoint was the change in maximum pain intensity related to motion of the neck, one week after the final treatment. Sensitivity was analysed per protocol (PP) and variant analyses were by intention to treat (ITT). Adjustment was made for confounders by multiple linear regression, including baseline values and rescue therapy. By ITT analysis, the change in the pain-VAS variable was greater among the experimental group (28.1 (95% CI 21.4-34.7)). The improvements in quality of life (physical aspect), active neck mobility and reduced rescue medication were clinically and statistically significant. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.
Abstract: BACKGROUND: Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). METHODS/DESIGN: Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. DISCUSSION: The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.
Abstract: BACKGROUND: In 1997, the first Pain Management Unit, which was set up as part of primary health care within the Andalusian Public Health System, offered acupuncture among other therapies. This observational study was conducted in preparation for a randomised controlled trial. METHODS: We conducted a descriptive study of patients who had been diagnosed with osteoarthritis of the knee. The patients received weekly acupuncture treatment, and related techniques, from November 1997 to November 2000. We recorded: socio-demographic data; measures of effectiveness, including intensity and frequency of pain; the daily dose of analgesic and anti-inflammatory medication; the degree of incapacity; and sleep disorders caused by pain in the knee. RESULTS: The 563 patients who presented were mainly female (88%) with an average age of 65 years (+/- 10.7); the average age of the male patients was 67 years (+/- 11.8). The condition in most patients (95%) was chronic: 54% had the condition for 5-10 years and a further 23% for more than 10 years. Of the total, 85 (15%) abandoned treatment and were excluded from the evaluation, while 75% of the remainder achieved a reduction in pain of 45% or more. This study is intended to form the basis for a subsequent controlled clinical trial of the effectiveness of acupuncture as a treatment for osteoarthritis of the knee. CONCLUSION: The degree of pain relief experienced by patients from acupuncture justifies a more rigorous study.
Abstract: OBJECTIVES: 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. DESIGN: Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. SETTING: Pain management unit in a public primary care centre in southern Spain, over a period of two years. PARTICIPANTS: 97 outpatients presenting with osteoarthritis of the knee. INTERVENTIONS: Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49). MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
