Finnish Tennis Elbow Trial Pilot Study (FINITE)
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|ClinicalTrials.gov Identifier: NCT02425982|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment|
|Tennis Elbow||Procedure: Operative treatment Procedure: Conservative treatment|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||Finnish Tennis Elbow Trial Pilot Study|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2029|
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.
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.
- 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.
- 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.
- QuickDASH [ Time Frame: up to 10 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.
- Success rate [ Time Frame: up to 10 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.
- Relapses [ Time Frame: up to 10 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 [ Time Frame: up to 10 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
- Time off work [ Time Frame: up to 10 years ]Number of sick leave days due to elbow symptoms.
- Complications and adverse effects [ Time Frame: up to 10 years ]Complications and adverse events related to treatment of the elbow. Predefined complications are: infection, iatrogenic injuries (especially nerve), crps, anaesthetic complications.
- Global improvement [ Time Frame: up to 10 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 [ Time Frame: up to 10 years ]OES will be assessed as a secondary outcome at 6, 12, 26 and 52 weeks and then at 2, 3, 4, 5 and 10 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425982
|Helsinki, Uusimaa, Finland, 00240|
|North Karelia Central Hospital|
|Central Finland Central Hospital|
|Kymenlaakso Central Hospital|
|Kuopio Unversity Hospital|
|Päijät-Häme Central Hospital|
|Oulu University Hospital|
|Satakunta Central Hospital|
|Seinäjoki Central Hospital|
|Tampere Unversity Hospital|
|Turku University Hospital|
|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|