Finnish Tennis Elbow Trial Pilot Study (FINITE)

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.

Study Overview

• Status: Completed
• Conditions: Tennis Elbow
• Intervention / Treatment: Procedure: Conservative treatment; Procedure: Operative treatment

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 Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Finland
  • Joensuu, Finland
    • North Karelia Central Hospital
  • Jyväskylä, Finland
    • Central Finland Central Hospital
  • Kotka, Finland
    • Kymenlaakso Central Hospital
  • Kuopio, Finland
    • Kuopio Unversity Hospital
  • Lahti, Finland
    • Päijät-Häme Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Pori, Finland
    • Satakunta Central Hospital
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
  • Tampere, Finland
    • Hatanpää Hospital
  • Tampere, Finland
    • Tampere Unversity Hospital
  • Turku, Finland
    • Turku University Hospital
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00240
      • Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who seek advice or treatment at the outpatient clinics of the centers taking part in the study will be assessed for eligibility. Those fulfilling the criteria defined below will be asked to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conservative treatment; Patients who will opt conservative treatment or patients treated conservatively by surgeon decision.	Procedure: Conservative treatment; The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.
Operative treatment; Patients who opt for surgery when offered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Time off work	Number of sick leave days due to elbow symptoms.	up to 2 years
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
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
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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Investigators: Study Director: Teppo LN Järvinen, MD, professor, Helsinki University, Helsinki University Central Hospital; Principal Investigator: Tuomas Lähdeoja, MD, Helsinki University, Helsinki University Central Hospital; Principal Investigator: Mikko Salmela, MD, Helsinki University, Helsinki University Central Hospital; Principal Investigator: Teemu Karjalainen, MD, PhD, Central Finland Central Hospital; Principal Investigator: Pirjo Toivonen, coordinator, Helsinki University, Hatanpää Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimated): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Tennis Elbow; Lateral elbow pain; Latera epicondylitis
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 65/13/03/02/2014