OBJECTIVES: To assess the feasibility of a study to evaluate the efficacy of self-administered acupressure in pain and related symptom management for older people with symptomatic knee osteoarthritis. Feasibility with regard to (1) sample recruitment and retention, (2) treatment fidelity and adherence, and (3) tolerability and adverse events was examined. METHODS: The study was a randomized controlled trial. Community-living older adults were recruited and randomly assigned to one of three groups: verum acupressure, sham acupressure, and usual care. Participants in the first two groups learned their respective acupressure protocol during their first center visit and from a set of materials. They were asked to practice the protocol at home once daily, 5 days a week, for 8 weeks. Participants attended three center visits and received weekly phone calls from a research assistant in an 8-week study period. Both quantitative and qualitative data collected from center visits and weekly phone calls were used to examine study feasibility. RESULTS: A total of 150 participants (mean age, 73 years; 38% men) were enrolled; 83% completed all three center visits. Among those assigned to verum and sham acupressure groups, 94% passed a fidelity check at the second visit, more than 80% reported performing self-administered acupressure as instructed most of the time, and about 10% reported discomfort from performing the acupressure. Thirty adverse events were reported; most were related to pre-existing health conditions. CONCLUSIONS: It is feasible to conduct a study of self-administered acupressure for symptom management in community-living older adults with knee osteoarthritis, although sample recruitment may be challenging.
BACKGROUND: Evidence suggests acupuncture may be effective for treating the symptoms of knee osteoarthritis. Offering this in a group setting may offer cost savings. The aim of this study was to establish the feasibility of a definitive trial to assess the clinical and cost-effectiveness of Western medical acupuncture given in groups, or given individually, for adults with severe knee pain attributable to osteoarthritis.
METHODS: A pilot randomised controlled trial (RCT) was conducted. Participants were recruited from seven general practices in Plymouth, Devon. Acupuncture was provided, at a dosage that increased up to and including electroacupuncture if no pain relief was reported, by one experienced acupuncturist in a community clinic. Potentially eligible adults aged at least 45 years with knee osteoarthritis were identified from practice registers, screened and randomised to either: (1) standardised advice and exercise booklet alone ('standard'); (2) booklet plus group acupuncture ('group'); and (3) booklet plus individual acupuncture ('individual'). Both acupuncture arms received up to ten treatments over 12 weeks. Recruitment, retention and data completion rates were recorded, and participants completed questionnaires on acceptability. We collected pain, stiffness and function data (using the Western Ontario McMaster Universities Osteoarthritis Index; WOMAC) and general health (EQ-5D) and economic measures at baseline and 14 weeks post-randomisation.
RESULTS: We screened 149 people and randomised 60 (40 %), 20 per arm. The overall 14 week follow-up rate was 77 %, but only 70 % in the 'standard' group; 4.1 % of data points were missing. The study was acceptable to participants. Changes in WOMAC pain score (intention to treat complete case analysis) from baseline to 14 week follow-up were: 'standard', 0.4 (95 % confidence interval (CI) -1.4, 2.2, n = 14); 'group' -3.2 (95 % CI -5.1, -1.4, n = 17); 'individual' -2.4 (95 % CI -4.1, -0.7, n = 15).
CONCLUSIONS: A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm.
TRIAL REGISTRATION: ISRCTN05305406.
INTRODUCTION: This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety.
METHODS: A multi-centre, non-blinded, parallel-group, randomised controlled trial compared moxibustion with usual care (UC) in KOA. 212 South Korean patients aged 40-70 were recruited from 2011-12, stratified by mild (Kellgren/Lawrence scale grades 0/1) and moderate-severe KOA (grades 2/3/4), and randomly allocated to moxibustion or UC for four weeks. Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee(s). UC was allowed. Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC), Short Form 36 Health Survey (SF-36v2), Beck Depression Inventory (BDI), physical performance test, pain numeric rating scale (NRS) and adverse events were evaluated at 5 and 13 weeks. K-WOMAC global score at 5 weeks was the primary outcome.
RESULTS: 102 patients (73 mild, 29 moderate-severe) were allocated to moxibustion, 110 (77 mild, 33 moderate-severe) to UC. K-WOMAC global score (moxibustion 25.42+/-SD 19.26, UC 33.60+/-17.91, p<0.01, effect size = 0.0477), NRS (moxibustion 44.77+/-22.73, UC 56.23+/-17.71, p<0.01, effect size = 0.0073) and timed-stand test (moxibustion 24.79+/-9.76, UC 25.24+/-8.84, p = 0.0486, effect size = 0.0021) were improved by moxibustion at 5 weeks. The primary outcome improved for mild but not moderate-severe KOA. At 13 weeks, moxibustion significantly improved the K-WOMAC global score and NRS. Moxibustion improved SF-36 physical component summary (p = 0.0299), bodily pain (p = 0.0003), physical functioning (p = 0.0025) and social functioning (p = 0.0418) at 5 weeks, with no difference in mental component summary at 5 and 13 weeks. BDI showed no difference (p = 0.34) at 5 weeks. After 1158 moxibustion treatments, 121 adverse events included first (n = 6) and second degree (n = 113) burns, pruritus and fatigue (n = 2).
CONCLUSIONS: Moxibustion may improve pain, function and quality of life in KOA patients, but adverse events are common. Limitations included no sham control or blinding.
TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0000130.
<b>BACKGROUND: </b>Knee osteoarthritis is a chronic disease associated with significant morbidity and economic cost. The efficacy of acupuncture in addition to traditional physical therapy has received little study.<b>OBJECTIVE: </b>The objective of this study was to compare the efficacy and safety of integrating a standardized true acupuncture protocol versus nonpenetrating acupuncture into exercise-based physical therapy (EPT).<b>METHODS: </b>This was a randomized, double-blind, controlled trial at 3 physical therapy centers in Philadelphia, PA. We studied 214 patients (66% African Americans) with at least 6 months of chronic knee pain and x-ray-confirmed Kellgren scores of 2 or 3. Patients received 12 sessions of acupuncture directly following EPT over 6 to 12 weeks. Acupuncture was performed at the same 9 points dictated by the traditional Chinese "Bi" syndrome approach to knee pain, using either standard needles or Streitberger non-skin-puncturing needles. The primary outcome was the proportion of patients with at least a 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index score at 12 weeks.<b>RESULTS: </b>Both treatment groups showed improvement from combined therapy with no difference between true (31.6%) and nonpenetrating acupuncture (30.3%) in Western Ontario and McMaster Universities Osteoarthritis Index response rate (P = 0.5) or report of minor adverse events. A multivariable logistic regression prediction model identified an association between a positive expectation of relief from acupuncture and reported improvement. No differences were noted by race, sex, or age.<b>CONCLUSIONS: </b>Puncturing acupuncture needles did not perform any better than nonpuncturing needles integrated with EPT. Whether EPT, acupuncture, or other factors accounted for any improvement noted in both groups could not be determined in this study. Expectation for relief was a predictor of reported benefit.
The efficacy of acupuncture as an adjunctive therapy to pharmacological treatment of chronic pain due to knee osteoarthritis was studied with a 3-armed, single-blind, randomized, sham-controlled trial; it compared acupuncture combined with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone. A total of 120 patients with knee osteoarthritis were randomly allocated to 3 groups: group I was treated with acupuncture and etoricoxib, group II with sham acupuncture and etoricoxib, and group III with etoricoxib. The primary efficacy variable was the Western Ontario and McMaster Universities (WOMAC) index and its subscales at the end of treatment at week 8. Secondary efficacy variables included the WOMAC index at the end of weeks 4 and 12, a visual analogue scale (VAS) at the end of weeks 4, 8, and 12, and the Short Form 36 version 2 (SF-36v2) health survey at the end of week 8. An algometer was used to determine changes in a predetermined unique fixed trigger point for every patient at the end of weeks 4, 8, and 12. Group I exhibited statistically significant improvements in primary and secondary outcome measures, except for Short Form mental component, compared with the other treatment groups. We conclude that acupuncture with etoricoxib is more effective than sham acupuncture with etoricoxib, or etoricoxib alone for the treatment of knee osteoarthritis.
OBJECTIVE: The goals of the present study were to evaluate the effect and safety of combined 10.6 microm and 650 nm laser acupuncture-moxibustion on patients with knee osteoarthritis (OA) and to validate a nonacupoint sham control for assessing the effect of point specificity on the treatment. MATERIALS AND METHODS: A randomized, sham-controlled clinical trial was conducted in an outpatient clinical setting on patients with knee OA (n = 40). Laser irradiation was performed on acupoint Dubi (ST35) and a sham point three times a week for 4 wk. Outcome measurements were performed at baseline and at wk 2 and 4 using Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC). RESULTS: At the 2-wk assessment, i.e., after 6 treatments, improvement in the WOMAC pain score of the acupoint group was significantly greater than that of the control group (49.21% vs. 11.99%, respectively; p = 0.021). However, there were no significant differences between the two groups in the WOMAC physical function score (p = 0.129) or joint stiffness score (p = 0.705). No side effects were found during the trial. CONCLUSIONS: Combined 10.6-mum-650-nm laser acupuncture-moxibustion on acupoint ST35 is safe to use and was effective after 2-wk treatment, but not at the 4-wk assessment, in relieving knee OA pain compared to a nonacupoint sham control. A larger clinical trial to verify our findings is warranted.
OBJECTIVES: To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham ('placebo' needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation.
METHODS: Acupuncture naïve patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed 'placebo' needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma beta-endorphin. The effectiveness of blinding was assessed.
RESULTS: There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P= 0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI -10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI -9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma beta-endorphin levels were not affected by either treatment.
CONCLUSIONS: Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma beta-endorphin during acupuncture.
OBJECTIVE: The purpose of this study was to investigate the effects and minimum effective dose of laser acupuncture in knee osteoarthritis (KOA), and to determine if it is superior to placebo treatment (sham) in the evaluation of clinical-functional outcome and quality of life.
METHODS: In this randomized, placebo-controlled study, patients with grade 2 and 3 primary KOA were selected. Group I (n = 27) received 904-nm low-level laser irradiation with 10 mW/cm(2) power density, 4 mW output power, 0.4 cm(2) spot size, 0.48 J dose per session, and 120-sec treatment time on the medial side of the knee to the acupuncture point Sp9. Group II (n = 25) received placebo-laser therapy at the same place on the same point. Patients in both of the groups had treatment 5 days per week (total duration of therapy was 10 days) and 20 min per day. The study was comprised of a 2-week (10-session) intervention. Participants were evaluated before treatment (baseline), after treatment (2nd week), and at the 12th week. In this double-blind study, a blind examiner carried out all outcome assessments. The main outcome measures were as follows: pain on movement (pVAS), 50-foot walking time (50 foot w), knee circumference (KC), medial tenderness score (MTS), Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and Nottingham Health Profile (NHP).
RESULTS: Statistically significant improvement was observed in PVAS, 50 foot w, and KC in group 1. In Group II, statistically significant improvement was observed in PVAS, 50 foot w, and WOMAC. When groups were compared with each other, the improvement observed in KC was superior in Group I at the 2(nd) week (p = 0.005).
CONCLUSION: Laser acupuncture was found to be effective only in reducing periarticular swelling when compared with placebo laser.
OBJECTIVE: To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee. DESIGN: Multicentre, randomised controlled trial. SETTING: 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom. Participants: 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis. INTERVENTIONS: Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119). Main outcome measures: The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months. RESULTS: Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval -1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (-0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture. CONCLUSION: The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects. (PsycINFO Database Record (c) 2016 APA, all rights reserved)
To assess the feasibility of a study to evaluate the efficacy of self-administered acupressure in pain and related symptom management for older people with symptomatic knee osteoarthritis. Feasibility with regard to (1) sample recruitment and retention, (2) treatment fidelity and adherence, and (3) tolerability and adverse events was examined.
METHODS:
The study was a randomized controlled trial. Community-living older adults were recruited and randomly assigned to one of three groups: verum acupressure, sham acupressure, and usual care. Participants in the first two groups learned their respective acupressure protocol during their first center visit and from a set of materials. They were asked to practice the protocol at home once daily, 5 days a week, for 8 weeks. Participants attended three center visits and received weekly phone calls from a research assistant in an 8-week study period. Both quantitative and qualitative data collected from center visits and weekly phone calls were used to examine study feasibility.
RESULTS:
A total of 150 participants (mean age, 73 years; 38% men) were enrolled; 83% completed all three center visits. Among those assigned to verum and sham acupressure groups, 94% passed a fidelity check at the second visit, more than 80% reported performing self-administered acupressure as instructed most of the time, and about 10% reported discomfort from performing the acupressure. Thirty adverse events were reported; most were related to pre-existing health conditions.
CONCLUSIONS:
It is feasible to conduct a study of self-administered acupressure for symptom management in community-living older adults with knee osteoarthritis, although sample recruitment may be challenging.
