Finnish Tennis Elbow Trial Pilot Study

Tennis Elbow Clinical Trial

— FINITE  

Official title:

Finnish Tennis Elbow Trial Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02425982
• Other study ID #: 65/13/03/02/2014
• Status: Active, not recruiting
• Start date: August 2015
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2020
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: May 31, 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
Finland	Töölö Hospital	Helsinki	Uusimaa
Finland	North Karelia Central Hospital	Joensuu
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Kymenlaakso Central Hospital	Kotka
Finland	Kuopio Unversity Hospital	Kuopio
Finland	Päijät-Häme Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Satakunta Central Hospital	Pori
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	Hatanpää Hospital	Tampere
Finland	Tampere Unversity Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years
Secondary	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".	up to 2 years
Secondary	Satisfaction with the treatment process	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	up to 2 years
Secondary	Time off work	Number of sick leave days due to elbow symptoms.	up to 2 years
Secondary	Complications and adverse effects	Complications and adverse events related to treatment of the elbow. Predefined complications are: infection, iatrogenic injuries (especially nerve), crps, anaesthetic complications.	up to 2 years
Secondary	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. The outcome measure will be assessed at 6, 12, 26 and 52 weeks and then at 2, 3, 4, 5 and 10 years	up to 2 years
Secondary	Oxford Elbow Score	OES will be assessed as a secondary outcome at 6, 12, 26 and 52 weeks and then at 2 years	up to 2 years