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Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial.

ABSTRACT: Background:Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatment of LE in terms of pain relief. The primary objective of this pilot trial was to assess the feasibility (retention and adherence rates) of performing a randomized controlled trial (RCT) to explore the clinical effectiveness of acupuncture and manual therapy treatment of LE. Methods:This pilot trial took place in an outpatient interdisciplinary institute of sports medicine and rehabilitation in Oslo, Norway. Thirty-six adults with clinically diagnosed LE were randomly allocated into one of three groups: eccentric exercise alone, eccentric exercise plus acupuncture, or eccentric exercise plus manual therapy for a 12-week treatment period. Primary outcomes were patient retention and adherence rates. Secondary outcomes included patient-reported pain (NRS), level of disability (Quick-DASH), and participant's satisfaction with treatment and global perceived effect. Results:Nine (69%) patients in the acupuncture group completed the 1-year follow-up, compared to eight (67%) in the manual therapy group and five (45%) in exercise alone. Our goal was to demonstrate a retention rate above 80% to avoid serious threats to validity, but the result was lower than expected. The majority of participants (64%) in both treatment groups received only three-treatment sessions; the reasons included non-attendance or recovery from pain. Secondary outcomes support the rationale for conduction of an RCT. There were no adverse advents related to study participation. Conclusions:Based on differences in pain relief between groups, patient retention, and adherence rates, an RCT seems to be feasible to assess treatment effectiveness more precisely. In a future definitive trial, greater dropout may be reduced by maintaining contact with the participants in the exercise alone group throughout the intervention, and objective assessments might be considered. Trial registration:ClinicalTrials.gov, NCT02321696.

SUBMITTER: Bostrom K

PROVIDER: S-EPMC6731611 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial.

Bostrøm Katrine K Mæhlum Sverre S Cvancarova Småstuen Milada M Storheim Kjersti K

Pilot and feasibility studies 20190907

<h4>Background</h4>Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatme ...[more]

PMID: 31516727

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Project description:BACKGROUND:The aim of this study was to compare the short-term and intermediate-term efficacy of acupuncture plus fire needle therapy with that of acupuncture alone in the treatment of lateral epicondylitis (LE). METHODS:Thirty-eight patients with LE who had persisted for at least 2 months were enrolled in this prospective, assessor-blinded, randomized controlled pilot trial. Twenty-one patients were randomized to the acupuncture plus fire needle group and 17 to the acupuncture-only group. The primary outcome was the visual analog scale pain score for the previous 24?hours and the secondary outcomes were the maximum grip strength, Patient-rated Forearm Evaluation Questionnaire score, and Medical Outcomes Study 36-Item Short-form Health Survey score. The values at baseline (pretreatment), at the end of treatment, and at 3 months after treatment were used to assess the short-term and intermediate-term effects of treatment. The data were analyzed using the Chi-square test and t test. RESULTS:Within-group analyses showed better results for acupuncture plus fire needle therapy in the short term and intermediate term. Differences in the severity of pain and secondary outcomes were significant in the intermediate term in the acupuncture group. At the end of treatment, none of the differences in outcome scores were significant, except for maximum grip strength in the affected hand in the acupuncture group. No significant between-group differences in short-term or intermediate-term outcomes were observed. CONCLUSION:Acupuncture plus fire needle therapy was effective in the short term in patients seeking improvement of LE. Twelve treatments were effective for relieving pain and improving disability in the intermediate term in patients with chronic LE in both study groups. The findings of the pilot study confirm the feasibility of proceeding to a larger randomized controlled study of the longer-term effects of acupuncture plus fire needle therapy in patients with LE.

Project description:PurposeTo compare the short-term outcomes between arthroscopic and open procedures for the treatment of lateral epicondylitis. Because a significant portion of patients have worker's compensation (WC), the outcomes in these subgroups were separately analyzed.MethodsA retrospective analysis of patients who had surgical treatment of lateral epicondylitis by a single surgeon from 2010 to 2017 was performed. Patients who were symptomatic after 9 months of conservative treatments including nonsteroidal medications, steroid injections, and physical therapy were offered surgical intervention. The type of surgery was selected after detailed consultation with the patient. Charts were reviewed for preoperative pain, grip strength as measured by dynamometer, smoking status, and WC status. Postoperative assessments included pain and grip strength at 6 weeks and time taken to return to full duty. Two groups were compared using unpaired t test and chi-squared tests. Results were compared with similar studies in the literature.ResultsThe study included 30 patients in the arthroscopic debridement group and 42 patients in the open tenotomy and reinsertion group. Eighteen patients (25%) had WC. Compared with the open group, the arthroscopic group had earlier return to full duty (mean 7.13 weeks, confidence interval [CI] 6.21 to 8.05 versu mean of 12.22 weeks, CI 11.21 to 13.24; P < .001) and less time for complete pain relief (mean 7.4 weeks, CI 7.02 to 7.93 versus 9.5 , CI 8.68 to 10.44; P = .043). No difference was seen among the groups in terms of unfavorable outcome (persistent pain and recurrence of pain), JAMAR hand dynamometer score at 6 weeks, and visual analog score at 6 weeks. A total of 11 patients (15%) had unfavorable outcome. Incidence of unfavorable outcomes was more in patients with WC insurance (36% in WC versus 7% in non-WC; P = .023). No association was seen with smoking status. WC patients also had a longer time to return to full duty (16.68 weeks for WC versus 7.65 weeks for non-WC; P < .001) and a longer time to get complete pain relief (12.4 weeks for WC versus 7.5 weeks for non-WC; P < .001).ConclusionThe arthroscopic technique offers advantages of earlier return to work and shorter recovery period along with additional advantages of joint inspection and ability to treat coexisting pathologies. WC patients had a longer time to return to full duty and time for complete pain relief.Level of evidenceLevel III, retrospective comparative study.

Project description:ObjectiveTo assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura.DesignMulticentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician.SettingSeven hospitals in China, 5 June 2016 to 15 November 2018.Participants150 acupuncture naive patients with episodic migraine without aura.Interventions20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks.Main outcome measuresChange in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation).ResultsAmong 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference -1.4, 95% confidence interval -2.4 to -0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference -2.1, -2.9 to -1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference -1.0, -1.5 to -0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891).ConclusionsTwenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.Trial registrationClinicaltrials.gov NCT02765581.

Project description:BackgroundPrimary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care.Methods/designThis is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS).DiscussionThis study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual.Trial registrationClinical Trials.gov NCT02783534 . Registered on 26 May 2016.

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Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial.

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Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial.

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