Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison

<p>Abstract</p> <p>Background</p> <p>Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a non-inflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues.</p> <p>Methods</p> <p>A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, cost-effectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression models. Healthcare costs will be collected from a societal perspective, and along with willingness-to-pay and quality of life data will facilitate cost-effectiveness and cost-benefit analyses.</p> <p>Conclusion</p> <p>This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. Findings from this study will assist in the development of evidence based practice recommendations and potentially the optimisation of resource allocation for rehabilitating lateral epicondylalgia.</p> <p>Trial registration</p> <p>Australian New Zealand Clinical Trials Register ACTRN12609000051246</p

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

Initial effects of elbow taping on pain-free grip strength and pressure pain threshold

Study design: Single-blind, placebo control, randomized, crossover, experimental Study with repeated measures, Objective: To determine the initial effects of a taping technique on grip strength and pain in individuals with lateral epicondylalgia. Background: Taping techniques are advocated for chronic musculoskeletal conditions such as lateral epicondylalgia, a prevalent disorder with significant impact on the individual and community. Little evidence exists supporting the effects of taping techniques on musculoskeletal pain. Methods and Measures: Sixteen participants (mean age +/- SD, 45.8 +/- 10.2 years) with chronic lateral epicondylalgia (rnean duration +/- SD, 13.1 +/- 9.9 months) participated in a placebo control study of an elbow taping technique. Outcome measures were pain-free grip strength and pressure pain threshold taken before, immediately after, and 30 minutes after application of tape. Results: The taping technique significantly improved pain-free grip strength by 24% from baseline (P = .028). The treatment effect was greater than that for placebo and control conditions. Changes in pressure pain threshold (19%), although positive, were not statistically significant. Conclusion: This preliminary study demonstrated an initial ameliorative effect of a taping technique for lateral epicondylalgia and suggests that it should be considered as an adjunct in the management of this condition

Effectiveness of Manual Physical Therapy to the Cervical Spine in the Management of Lateral Epicondylalgia: A Retrospective Analysis

Design: Retrospective ex-post facto design. Objectives: To retrospectively review the management of patients with lateral epicondylalgia, and to compare self-reported outcomes to assess the potential benefit of manual physical therapy to the cervical spine. Background: It has been postulated that dysfunction of the cervical spine may contribute to the symptoms associated with lateral epicondylalgia; however, the literature assessing the effectiveness of manual physical therapy to the cervicothoracic region in this patient population has been inconclusive. Documentation and analysis of outcomes of management strategies focusing on the cervical spine may lead to determining the most effective and efficient clinical practices. Methods and Measures: Of the 213 charts reviewed, 112 satisfied inclusion-exclusion criteria and were divided into 2 groups: those who received treatment solely directed at the elbow (local management [LM]), or those who received treatment directed at the elbow and cervical manual therapy (LM+C). Telephone follow-up interviews were used to determine the number of successful outcomes. Percentages of successful outcomes in each group were compared using chi-square analysis. An independent samples t test was used to compare the total number of visits per group. Results: Sixty-one of the 112 patients were in the LM group, while 51 received LM+C. Seventy five percent of the patients available for follow-up in the LM group and 80% in the LM+C group reported a successful outcome. Patients in the LM group received a greater number of visits (mean, 9.7; SD, 2.4) than patients in the LM+C group (mean, 5.6; SD, 1.7; P\u3c.01). Conclusions: The results of this retrospective review suggest that most patients had successful outcomes regardless of the inclusion of manual therapy interventions to the cervical spine. The LM+C group achieved the successful long-term outcome in significantly fewer visits