Tennis ElbowFINITENCT02425982

Finnish Tennis Elbow Trial Pilot Study

An observational study of Tennis Elbow, run by University of Helsinki at 12 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 60 years
Conditions the study is for: Tennis Elbow
What is being tested?: Operative treatment and Conservative treatment
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 99 participants
Where: 12 sitesFinland
Study dates: Aug 2015to 15 Mar 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 60 years
All sexes
No healthy volunteers
Adult

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.

Who may be able to join

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.
Duration of symptoms over 10 months
Age between 35 and 60 years
Ability to fill in Finnish questionnaires
Written informed consent

Who cannot join

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:
Pain in the medial epicondyle of the elbow

Show all 11Show fewer

Pain in the biceps muscle tendon
Painful snapping or crepitus of elbow joint
Instability of elbow joint (table top, posterolateral drawer test)
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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Finland12 sites

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

Other trials in Finland

About this study

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.

Read the detailed description

Objectives:

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.

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: Tennis Elbow
Being tested: Operative treatment, Conservative treatment
Keywords: Tennis Elbow, Lateral elbow pain, Latera epicondylitis
Medical subject headings: Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Operative treatmentProcedure or surgery
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 treatmentProcedure or surgery
The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.

Study groups in NCT02425982
Study group	Role	What they receive
Conservative treatment		Patients who will opt conservative treatment or patients treated conservatively by surgeon decision. Receives: Procedure: Conservative treatment
Operative treatment		Patients who opt for surgery when offered. Receives: Procedure: Operative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 months

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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".
Measured: 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
Measured: up to 2 years
Time off work
Number of sick leave days due to elbow symptoms.
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201515 Mar 2018

First posted24 Apr 2015 (estimated)
Study startAug 2015
Primary completion15 Mar 2018
Study completion15 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tennis ElbowStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425982
Sponsor's protocol ID: 65/13/03/02/2014
Acronym: FINITE
Status last verified: Jan 2025
First submitted: 6 Apr 2015
Last updated: 7 Jan 2025
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 37415100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
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Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
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Metabolic and Inflammatory Indices in Lateral Epicondylitis
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All Tennis Elbow trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Finnish Tennis Elbow Trial Pilot Study
ClinicalTrials.gov ID: NCT02425982
Acronym / sponsor ID: FINITE / 65/13/03/02/2014
Conditions: Tennis Elbow
Keywords: Tennis Elbow, Lateral elbow pain, Latera epicondylitis
Study type: Observational
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: University of HelsinkiUniversity, hospital or other
Study start: Aug 2015
Primary completion: 15 Mar 2018 (actual)
Study completion: 15 Mar 2018 (actual)
First posted: 24 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Conservative treatment	–	Procedure: Conservative treatmentPatients who will opt conservative treatment or patients treated conservatively by surgeon decision.
Operative treatment	–	Procedure: Operative treatmentPatients who opt for surgery when offered.

Who may qualify

Ages: 35 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
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.

Key inclusion criteria (5 listed)

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.
Duration of symptoms over 10 months
Age between 35 and 60 years
Ability to fill in Finnish questionnaires
Written informed consent

Key exclusion criteria (11 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Operative treatmentThe 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.	Procedure or surgery	Operative treatment
Conservative treatmentThe treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.	Procedure or surgery	Conservative treatment

Primary outcome

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.

8 secondary outcomes

QuickDASH
Time frame: up to 2 years
Success rate
Time frame: up to 2 years
Relapses
Time frame: up to 2 years
Satisfaction with the treatment process
Time frame: up to 2 years
Time off work
Time frame: up to 2 years
Complications and adverse effects
Time frame: up to 2 years
Global improvement
Time frame: up to 2 years
Oxford Elbow Score
Time frame: up to 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Derived from this study: PubMed 37415100Karjalainen 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.

Related trials for Tennis Elbow

Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teppo LN Järvinen, MD, professor study director

Helsinki University, Helsinki University Central Hospital

Tuomas Lähdeoja, MD principal investigator

Helsinki University, Helsinki University Central Hospital

Mikko Salmela, MD principal investigator

Helsinki University, Helsinki University Central Hospital

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tennis Elbow, run by University of Helsinki at 12 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global improvement (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.