NCT02425982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

April 6, 2015

Last Update Submit

January 4, 2025

Conditions

Tennis Elbow

Keywords

Tennis ElbowLateral elbow painLatera epicondylitis

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (8)

  • QuickDASH

    up to 2 years

  • Success rate

    up to 2 years

  • Relapses

    up to 2 years

  • Satisfaction with the treatment process

    up to 2 years

  • Time off work

    up to 2 years

  • +3 more secondary outcomes

Study Arms (2)

Conservative treatment

Patients who will opt conservative treatment or patients treated conservatively by surgeon decision.

Procedure: Conservative treatment

Operative treatment

Patients who opt for surgery when offered.

Procedure: Operative treatment

Interventions

Operative treatmentPROCEDURE

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.

Operative treatment
Conservative treatmentPROCEDURE

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

Conservative treatment

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Töölö Hospital

Helsinki, Uusimaa, 00240, Finland

Location

North Karelia Central Hospital

Joensuu, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Kymenlaakso Central Hospital

Kotka, Finland

Location

Kuopio Unversity Hospital

Kuopio, Finland

Location

Päijät-Häme Central Hospital

Lahti, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Hatanpää Hospital

Tampere, Finland

Location

Tampere Unversity Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

  • 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.

    PMID: 37415100DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • 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 Central Hospital

    PRINCIPAL INVESTIGATOR

  • Pirjo Toivonen, coordinator

    Helsinki University, Hatanpää Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, specialist in orthopaedics and traumatology

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 24, 2015

Study Start

August 1, 2015

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

FI(12)