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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.
Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment | Patients who will opt conservative treatment or patients treated conservatively by surgeon decision. |
| |
| Operative treatment | Patients who opt for surgery when offered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Teppo LN Järvinen, MD, professor | Helsinki University, Helsinki University Central Hospital | Study Director |
| 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 Hospital District | Principal Investigator |
| Pirjo Toivonen, coordinator | Helsinki University, Hatanpää Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital | Helsinki | Uusimaa | 00240 | Finland | ||
| North Karelia Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37415100 | Derived | 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. |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Conservative treatment | Procedure | The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided. |
|
| 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 |
| 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 |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |