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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
Sponsor:
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University

Brief Summary:
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.

Condition or disease Intervention/treatment
Tennis Elbow Procedure: Operative treatment Procedure: Conservative 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.


Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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".

  4. 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

  5. Time off work [ Time Frame: up to 10 years ]
    Number of sick leave days due to elbow symptoms.

  6. 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.

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
Finland
Töölö Hospital
Helsinki, Uusimaa, Finland, 00240
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
Sponsors and Collaborators
Helsinki University
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

Responsible Party: Tuomas Lahdeoja, MD, specialist in orthopaedics and traumatology, Helsinki University
ClinicalTrials.gov Identifier: NCT02425982     History of Changes
Other Study ID Numbers: 65/13/03/02/2014
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Tuomas Lahdeoja, Helsinki University:
Tennis Elbow
Lateral elbow pain
Latera epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries