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. 2011 Mar 16;2011(3):CD003525. doi: 10.1002/14651858.CD003525.pub2

Meknas 2008.

Methods Randomised controlled trial; pre‐specified sample size calculation not reported. 
 Overall validity of results: high risk of bias.
Participants 24 patients, 11 women and 13 men; mean age 49.2 years (range 36‐62 years) in the release group, and 46.7 years (range 30‐64 years) in the microtenotomy group; mean symptom duration in the release group was 27.6 months (range 12‐60 months), and 22 months (range 12‐50 months) in the microtenotomy group.
Inclusion criteria: pain and tenderness in the lateral epicondylar area with exacerbation of pain with resisted extension in the wrist and digits, minimum symptom duration 12 months, and all participants failed conservative treatment which consisted of at least 3 injections with corticosteroid drugs that had a short‐term effect, NSAIDs for several weeks without clear improvement and physical therapy in primary health care institutes over a period of at least 3 months.
Exclusion criteria: patients with cancer, severe systemic diseases, seriously reduced general health status, or with an unclear diagnosis with diffuse pain.
Interventions All operations were performed by a single orthopaedic surgeon as outpatient procedures using local anaesthesia and sedation.
Group 1, extensor tendon release and repair ('release group') (11 people): 3 to 4 cm incision centred slightly distal to the lateral epicondyle, and the origin of the common extensor was exposed by dissection, the interval between the extensor carpi radialis longus (ECRL) and extensor digitorum communis (EDC) was widened by a small incision in line with the fibres, exposing the extensor carpi radialis brevis (ECRB). The proximal origin of ECRB was released from its attachment, the damaged portion of the tendon was removed, and the epicondyle decorticated. Median length of the operation was 30 minutes (range 22‐40 minutes).
Group 2, microtenotomy group (13 people): 3cm incision over epicondyle to expose the extensor tendon, radiofrequency (RF) energy delivered via a Topaz electrode perpendicular to the tendon surface in a grid‐like pattern of 3 to 6 micro ablations; tendon penetrated 3 to 5mm deep to perform micro ablation. Median length of the operation was 18 minutes (range 10‐23 minutes).
Outcomes Outcomes measured at baseline, 3, 6 and 12 weeks post‐operatively. Pain also assessed at 10 to 18 months via telephone interview.
1) Pain: measured using a 0 to 10 point visual analogue (VAS) scale; 0 = no pain.
2) Grip strength: measured using a dynamometer in kg.
3) Function: measured by the Mayo Elbow Performance Score (MEPS). This is a multidimensional 100 point scale that includes 4 domains (pain ‐ maximum score of 45 points, function ‐ maximum score of 25 points, motion ‐ maximum score of 20 points, and stability ‐ maximum score of 10 points). A higher score reflects a better outcome.
4) Time to return to work.
5) Presence of lateral epicondylitis as indicated by 'hot spot' with dynamic infrared thermography (DIRT).
6) Adverse effects.
Sources of funding Not reported. The authors report no conflict of interests.
Notes No standard deviations (SD) were reported for pain, grip strength and function in the published trial, however the authors provided them upon request.
The trial authors reported that there was a lack of difference between treatments for all outcomes at all time points. We were able to perform a re‐analysis for the outcome of pain and we found that there was a significant difference between groups at 3 weeks favouring microtenotomy (MD ‐2.80 (‐5.07, ‐0.5), but no difference between groups at other time points for this outcome. We presented pain outcomes in RevMan at all time points, but at the last time point only for other outcomes (12 weeks for function; 12 weeks for strength).
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Participants assigned to treatment group on day of operation by 'drawing lots'
Allocation concealment? Low risk Not reported in trial but personal correspondence with author (K Meknas) indicates 24 sealed envelopes, half indicating ECRB release, and half microtenotomy were available in the operating theatre; the participants were allocated treatment by drawing lots
Blinding? 
 All outcomes High risk Patients informed of operation they would be receiving once they entered the operating theatre (personal communication, K Meknas); unclear if outcome assessors were aware of treatment, but participants could have informed them
Incomplete outcome data addressed? 
 All outcomes Low risk Outcomes appeared to be included for all enrolled participants although not stated explicitly
Free of selective reporting? High risk All outcomes that were prespecified in the methods are included in the results however the results for all time points are not reported and some results are . Only the results for pain are presented for baseline, 3,6, 12 weeks and between 10 and 18 months. MEPS and grip strength are only reported for baseline and 12 weeks
Trial authors did not report SD in the published report, but provided SDs upon request
Free of other bias? Low risk