NCT02425982

Finnish Tennis Elbow Trial Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tennis Elbow

Interventions

Type	Name	Description
PROCEDURE	Operative treatment	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.
PROCEDURE	Conservative treatment	The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-03-15
• Completion: 2018-03-15
• First posted: 2015-04-24
• Last updated: 2025-01-07

Locations

12 sites across 1 country: Finland