Skip to main content
OpenTrials
Completed

NCT Number: NCT02425982

Finnish Tennis Elbow Trial Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Töölö Hospital, Helsinki, Uusimaa, Finland

Loading trial locations.

About this study

Objectives:

  • 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.
  • To investigate the patients' expectations of the treatment, and define the patient acceptable symptomatic state, or PASS, in tennis elbow.
  • To investigate the effect of pain behaviour on treatment results and PASS.
  • To delineate the existence of a potential "response shift" -phenomenon in patients with a tennis elbow.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Duration of symptoms over 10 months
  • Age between 35 and 60 years
  • Ability to fill in Finnish questionnaires
  • Written informed consent

Exclusion criteria

  • Earlier fracture or dislocation in the elbow joint area
  • Earlier surgical treatment of the same elbow joint
  • Congenital deformity in the elbow
  • Systemic muscle, tendon, nerve or joint disease
  • Other problems causing pain the elbow joint:
  • Pain in the medial epicondyle of the elbow
  • Pain in the biceps muscle tendon
  • Painful snapping or crepitus of elbow joint
  • Instability of elbow joint (table top, posterolateral drawer test)
  • A passive movement limitation of more than 10 degrees in the elbow joint
  • Abnormal finding in an elbow joint X-ray. An elbow joint X-ray is a routine examination of elbow symptoms.

Treatment and study plan

Operative treatment

Procedure

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

Procedure

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

Primary outcomes

  1. Global improvement

    Time frame: 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.

  2. Oxford Elbow Score

    Time frame: 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.

Secondary outcomes

  1. QuickDASH

    Time frame: 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.

  2. Success rate

    Time frame: 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.

  3. Relapses

    Time frame: 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".

  4. Satisfaction with the treatment process

    Time frame: 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

  5. Time off work

    Time frame: up to 2 years

    Number of sick leave days due to elbow symptoms.

  6. Complications and adverse effects

    Time frame: 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.

  7. Global improvement

    Time frame: 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

  8. Oxford Elbow Score

    Time frame: up to 2 years

    OES will be assessed as a secondary outcome at 6, 12, 26 and 52 weeks and then at 2 years

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Acronym: FINITE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2015
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.