NCT00888225

Brief Summary

Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

October 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

4.3 years

First QC Date

April 24, 2009

Last Update Submit

April 24, 2009

Conditions

Lateral Epicondylitis

Keywords

Tennis elbowEpicondylitisPainMuscle strengthQuality of lifeRCTTendinitisChronic tennis elbow

Outcome Measures

Primary Outcomes (1)

  • Pain during dynamic and static muscle load

    Month 0, 1, 2, 3, 6, 12

Secondary Outcomes (1)

  • Muscle strength and function

    Month 0, 1, 2, 3, 6, 12

Study Arms (2)

Eccentric exercise

EXPERIMENTAL

Group exposed to eccentric exercise treatment

Procedure: Eccentric exercise

Concentric exercise

ACTIVE COMPARATOR

Group exposed to concentric exercise treatment

Procedure: Concentric exercise

Interventions

Eccentric exercisePROCEDURE

Eccentric exercise treatment performed at home with three sets of 15 repetitions daily

Eccentric exercise
Concentric exercisePROCEDURE

Concentric exercise treatment at home with three sets of 15 repetitions daily

Concentric exercise

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Verified tennis elbow for more than three months
  • Age 20-75 years
  • Informed consent

You may not qualify if:

  • Inability to understand or follow instructions
  • Inability to read or fill in questionnaires
  • Inability to participate at measurement sessions
  • Supinator syndrome
  • Compartment syndrome of anconeus muscle
  • Rhizopathy of arm
  • Inflammatory joint or soft tissue disease including fibromyalgia
  • Previous surgery because of tennis elbow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linköping University

Linköping, SE-58183, Sweden

Location

Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section

Uppsala, SE-75185, Sweden

Location

Related Publications (2)

  • Peterson M, Svardsudd K, Appel L, Engler H, Aarnio M, Gordh T, Langstrom B, Sorensen J. PET-scan shows peripherally increased neurokinin 1 receptor availability in chronic tennis elbow: visualizing neurogenic inflammation? PLoS One. 2013 Oct 14;8(10):e75859. doi: 10.1371/journal.pone.0075859. eCollection 2013.

    PMID: 24155873DERIVED

  • Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of exercise versus wait-list in chronic tennis elbow (lateral epicondylosis). Ups J Med Sci. 2011 Nov;116(4):269-79. doi: 10.3109/03009734.2011.600476.

    PMID: 22066975DERIVED

Related Links

MeSH Terms

Conditions

Tennis ElbowPainTendinopathy

Condition Hierarchy (Ancestors)

Elbow TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kurt Svärdsudd, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

October 1, 2003

Primary Completion

January 1, 2008

Study Completion

December 1, 2008

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

SE(2)