Finnish Tennis Elbow Trial Pilot Study

University of Helsinki99 enrolled

Overview

The study aims to investigate the natural course and the results of operative treatment of chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a year. The investigators will also study the effect of pain catastrophising on the subjective outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE. The study will also ascertain the feasibility of a multi-center randomised, controlled trial (RCT), and test and refine the co-operation and interaction of the planned RCT centers.

Objectives: 1. To study the natural course of tennis elbow/spontaneous recovery of chronic (lasting for over 12 months) tennis elbow and the results of surgery in a pragmatic setting. 2. To investigate the patients' expectations of the treatment, and define the patient acceptable symptomatic state, or PASS, in tennis elbow. 3. To investigate the effect of pain behaviour on treatment results and PASS. 4. To delineate the existence of a potential "response shift" -phenomenon in patients with a tennis elbow. 5. To determine the feasibility of a prospective, placebo-controlled, randomised trial by finding out the actual number of patients in each center and those that may be suitable for the FINITE-RCT. The investigators will also test the functioning and response of the planned outcome measures in this environment and for this purpose. Study setting The study is carried out as a prospective open-label multi-center cohort study. The study was originally planned with a follow-up up to 10 years, but the cost-benefit of the long term follow-up was evaluated after the completion of one year data collection, and the decision was made to shorten the follow-up to include two year data, but no further follow-ups.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tennis Elbow

Interventions

Operative treatmentPROCEDURE

The exact treatment depends on the surgeon, but the majority are anticipated to be elbow arthroscopy followed by either arthroscopic or open extensor carpi radialis brevis release.

Conservative treatmentPROCEDURE

The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinically diagnosed tennis elbow defined as: Pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and during resisted extension of the wrist or when making a fist with the elbow joint straight. 2. Duration of symptoms over 10 months 3. Age between 35 and 60 years 4. Ability to fill in Finnish questionnaires 5. Written informed consent Exclusion Criteria: 1. Earlier fracture or dislocation in the elbow joint area 2. Earlier surgical treatment of the same elbow joint 3. Congenital deformity in the elbow 4. Systemic muscle, tendon, nerve or joint disease 5. Other problems causing pain the elbow joint: 1. Pain in the medial epicondyle of the elbow 2. Pain in the biceps muscle tendon 3. Painful snapping or crepitus of elbow joint 4. Instability of elbow joint (table top, posterolateral drawer test) 6. A passive movement limitation of more than 10 degrees in the elbow joint 7. Abnormal finding in an elbow joint X-ray. An elbow joint X-ray is a routine examination of elbow symptoms.

Locations (12)

Töölö Hospital

Helsinki, Uusimaa, Finland

North Karelia Central Hospital

Joensuu, Finland

Central Finland Central Hospital

Jyväskylä, Finland

Kymenlaakso Central Hospital

Outcomes

Primary Outcomes

Global improvement

A six-point Likert scale (much worse - worse - no change - better - much better - complete recovery) will be used and the patient is asked how the elbow symptoms are compared to the situation at the time of the initial visit and inclusion to the study.

Time frame: 6 months

Oxford Elbow Score

Oxford Elbow Score (OES) is a three-dimensional questionnaire consisting of 12 multiple-choice questions answered by the patient. OES has been validated for patients with surgically treated elbow problems. OES is the most robust elbow-specific PROM available currently.

Time frame: 6 months

Secondary Outcomes

QuickDASH

QuickDASH is a validated patient reported outcome measure of the function the upper extremities. It consists of 11 questions and 4 work-related questions. An approved Finnish translation has been made earlier. The outcome measure will be assessed as a secondary outcome at 6, 12, 26 and 52 weeks and then at 2, 3, 4, 5 and 10 years.

Time frame: up to 2 years

Success rate

Success is defined at any follow-up time point as patients who report "much better" or "complete recovery" in the second primary outcome question.

Time frame: up to 2 years

Relapses

Relapses are calculated from the Likert answers so that if the patient reports "much better" or "completely healed" at time point X and the answer is "better" or any of the poorer alternatives on follow-up point X+1, this is interpreted as a relapse for X+1 point in time. Relapses are calculated for each follow-up point in time and the patients are considered to remain in "relapse" until they report "much better" or "completely healed".

Time frame: up to 2 years

Data from ClinicalTrials.gov

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