Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: A protocol for a randomised, placebo-controlled study

<p>Abstract</p> <p>Background</p> <p>Lateral epicondylitis is a painful condition responsible for loss of function and sick leave for long periods of time. In many countries, the treatment guidelines recommend a wait-and-see policy, reflecting that no conclusions on the best treatment can be drawn from the available research, published studies and meta-analyses.</p> <p>Methods/Design</p> <p>Randomized double blind controlled clinical trial in a primary care setting. While earlier trials have either compared corticosteroid injections to physical therapy or to naproxen orally, we will compare the clinical effect of physiotherapy alone or physiotherapy combined with corticosteroid injection in the initial treatment of acute tennis elbow. Patients seeing their general practitioner with lateral elbow pain of recent onset will be randomised to one of three interventions: 1: physiotherapy, corticosteroid injection and naproxen or 2: physiotherapy, placebo injection and naproxen or 3: wait and see treatment with naproxen alone. Treatment and assessments are done by two different doctors, and the contents of the injection is unknown to both the treating doctor and patient. The primary outcome measure is the patient's evaluation of improvement after 6, 12, 26 and 52 weeks. Secondary outcome measures are pain, function and severity of main complaint, pain-free grip strength, maximal grip strength, pressure-pain threshold, the patient's satisfaction with the treatment and duration of sick leave.</p> <p>Conclusion</p> <p>This article describes a randomized, double blind, controlled clinical trial with a one year follow up to investigate the effects of adding steroid injections to physiotherapy in acute lateral epicondylitis.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier: NCT00826462</p

Corticosteroid or placebo injection combined with deep transverse friction massage, Mills manipulation, stretching and eccentric exercise for acute lateral epicondylitis: a randomised, controlled trial

Background Lateral epicondylitis of the elbow is a frequent condition with long-lasting symptoms. Corticosteroid injection is increasingly discouraged and there is little knowledge on the combined effect of corticosteroid injection and physiotherapy for acute conditions. We wanted to investigate the efficacy of physiotherapy alone and combined with corticosteroid injection for acute lateral epicondylitis. Methods A randomized, controlled study with one-year follow-up was conducted in a general practice setting in Sarpsborg, Norway. We included 177 men and women aged 18 to 70 with clinically diagnosed lateral epicondylitis of recent onset (2 weeks to 3 months). They were randomly assigned to one of three treatments: physiotherapy with two corticosteroid injections, physiotherapy with two placebo injections or wait-and-see (control). Physiotherapy consisted of deep transverse friction massage, Mills manipulation, stretching, and eccentric exercises. We used double blind injection of corticosteroid and single blind assessments. The main outcome measure was treatment success defined as patients rating themselves completely recovered or much better on a six-point scale. Results One hundred fifty-seven patients (89 %) completed the trial. Placebo injection with physiotherapy showed no significant difference compared to control or to corticosteroid injection with physiotherapy at any follow-up. Corticosteroid injection with physiotherapy had a 10.6 times larger odds for success at six weeks (odds ratio 10.60, p < 0.01) compared to control (NNT = 3, 99 % CI 1.5 to 4.2). At 12 weeks there was no significant difference between these groups, but at 26 weeks the odds for success were 91 % lower (OR 0.09, p < 0.01) compared to control, showing a large negative effect (NNT = 5, 99 % CI 2.1 to 67.4). At 52 weeks there was no significant difference. Both control and placebo injection with physiotherapy showed a gradual increase in success. Conclusions Acute lateral epicondylitis is a self-limiting condition where 3/4 of patients recover within 52 weeks. Physiotherapy with deep transverse friction massage, Mills manipulation, stretching, and eccentric exercises showed no clear benefit, and corticosteroid injection gave no added effect. Corticosteroid injections combined with physiotherapy might be considered for patients needing a quick improvement, but intermediate (12 to 26 weeks) worsening of symptoms makes the treatment difficult to recommend. Trial registration ClinicalTrials.gov Identifier: NCT0082646

Treating lateral epicondylitis with corticosteroid injections or non-electrotherapeutical physiotherapy: a systematic review

Objectives. To evaluate the current evidence for the efficacy of corticosteroid injection and non-electrotherapeutic physiotherapy compared with control for treating lateral epicondylitis. Design. Systematic review. Participants. We searched five databases in September 2012 for randomised controlled studies with a minimum quality rating. Of the 640 studies retrieved, 11 were included, representing 1161 patients of both sexes and all ages. Interventions. Corticosteroid injection and non-electrotherapeutic physiotherapy. Outcome measures. Relative risk (RR) or standardised mean difference (SMD) for overall improvement, pain and grip strength at 4–12, 26 and 52 weeks of follow-up. Results. Corticosteroid injection gave a short-term reduction in pain versus no intervention or non-steroidal anti-inflammatory drugs (SMD -1.43, 95% CI -1.64 to -1.23). At intermediate follow-up, we found an increase in pain (SMD 0.32, 95% CI 0.13 to 0.51), reduction in grip strength (SMD -0.48, 95% CI -0.73 to -0.24) and negative effect on the overall improvement effect (RR 0.66 (0.53 to 0.81)). For corticosteroid injection versus lidocaine injection, the evidence was conflicting. At long-term follow-up, there was no difference on overall improvement and grip strength, with conflicting evidence for pain. Manipulation and exercise versus no intervention showed beneficial effect at short-term follow-up (overall improvement RR 2.75, 95% CI 1.30 to 5.82), but no significant difference at intermediate or long-term follow-up. We found moderate evidence for short-term and long-term effects of eccentric exercise and stretching versus no intervention. For exercise versus no intervention and eccentric or concentric exercise and stretching versus stretching alone, we found moderate evidence of no short-term effect. Conclusions. Corticosteroid injections have a short-term beneficial effect on lateral epicondylitis, but a negative effect in the intermediate term. Evidence on the long-term effect is conflicting. Manipulation and exercise and exercise and stretching have a short-term effect, with the latter also having a long-term effect

Predictors for outcome in acute lateral epicondylitis

Background Lateral epicondylitis or tennis elbow is a frequent condition with long-lasting symptoms. In order to identify predictors for treatment success and pain in lateral epicondylitis, we used data from a randomized controlled trial. This trial investigated the efficacy of physiotherapy alone or combined with corticosteroid injection for acute lateral epicondylitis in general practice. Methods The outcomes treatment success and pain score on VAS were assessed at 6, 12, 26 and 52 weeks. We ran a univariate binary logistic regression with generalized estimating equations (GEE) and subsequently an adjusted multilevel logistic regression to analyze the association between potential prognostic indicators and the outcome success/ no success. To assess the changes in pain score we used a two-level multilevel linear regression (MLR) followed by an adjusted MLR model with random effects. Results The most consistent predictor for reduced treatment success at all time points was a high Pain Free Function Index score signifying more pain on everyday activities. Being on paid sick-leave and having a recurring complaint increased short term treatment success but gave decreased long-term treatment success. The patients reporting symptoms after engaging in probable overuse in an unusual activity, tended towards increased treatment success at all time-points, but significant only at 12 weeks. The most consistent predictor of increased pain at all time points was a higher overall complaints score at baseline. Conclusions: Our results suggest that in treating acute lateral epicondylitis, a consideration of baseline pain, a registration of the patient’s overall complaint on a VAS scale and an assessment of the patient’s perceived performance in everyday activities with the Pain Free Function Index can be useful in identifying patients that will have a more protracted and serious condition. Trial registration ClinicalTrials.gov Identifier: NCT00826462 . Date of registration January 22, 2009. The Trial was prospectively registrated