Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2015-08-31
2018-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Conservative treatment
Patients who will opt conservative treatment or patients treated conservatively by surgeon decision.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
60 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Responsible Party
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Tuomas Lahdeoja
MD, specialist in orthopaedics and traumatology
Principal Investigators
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Teppo LN Järvinen, MD, professor
Role: STUDY_DIRECTOR
Helsinki University, Helsinki University Central Hospital
Tuomas Lähdeoja, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University, Helsinki University Central Hospital
Mikko Salmela, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University, Helsinki University Central Hospital
Teemu Karjalainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Central Finland Central Hospital
Pirjo Toivonen, coordinator
Role: PRINCIPAL_INVESTIGATOR
Helsinki University, Hatanpää Hospital
Locations
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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, , Finland
Countries
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References
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Karjalainen T, Lahdeoja T, Salmela M, Ardern CL, Juurakko J, Jarvinen TL, Taimela S; FINITE investigators. Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow. BMC Med Res Methodol. 2023 Jul 6;23(1):158. doi: 10.1186/s12874-023-01934-4.
Other Identifiers
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65/13/03/02/2014
Identifier Type: -
Identifier Source: org_study_id
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