Finnish Tennis Elbow Trial Pilot Study

Completed

• Conditions: Tennis Elbow
• Interventions: Procedure: Conservative treatment; Procedure: Operative treatment

• Registration Number: NCT02425982
• Lead Sponsor: University of Helsinki

Brief 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.

Study Timeline

• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2015-08
• Primary Completion: 2018-03-15
• Study Completion: 2018-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	Patients who will opt conservative treatment or patients treated conservatively by surgeon decision.
Operative treatment	Operative treatment	Patients who opt for surgery when offered.

Primary Outcome Measures

Name	Time	Method
Oxford Elbow Score	6 months	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.
Global improvement	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Time off work	up to 2 years	Number of sick leave days due to elbow symptoms.
Complications and adverse effects	up to 2 years	Complications and adverse events related to treatment of the elbow. Predefined complications are: infection, iatrogenic injuries (especially nerve), crps, anaesthetic complications.
Relapses	up to 2 years	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".
Satisfaction with the treatment process	up to 2 years	this is evaluated with the question "On a scale of 0 to 10, (with 10 on as 'very satisfied' and 0 as 'very dissatisfied'), how satisfied are you with the treatment you have received as a whole?" 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
Success rate	up to 2 years	Success is defined at any follow-up time point as patients who report "much better" or "complete recovery" in the second primary outcome question.
Global improvement	up to 2 years	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. The outcome measure will be assessed at 6, 12, 26 and 52 weeks and then at 2, 3, 4, 5 and 10 years
Oxford Elbow Score	up to 2 years	OES will be assessed as a secondary outcome at 6, 12, 26 and 52 weeks and then at 2 years
QuickDASH	up to 2 years	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.

Trial Locations

Locations (12)

North Karelia Central Hospital; 🇫🇮 Joensuu, Finland

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland

Töölö Hospital; 🇫🇮 Helsinki, Uusimaa, Finland

Kuopio Unversity Hospital; 🇫🇮 Kuopio, Finland

Hatanpää Hospital; 🇫🇮 Tampere, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland

Kymenlaakso Central Hospital; 🇫🇮 Kotka, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Tampere Unversity Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland