Tennis Elbow Trial | NCT00888225

Studies
Tennis Elbow Trial

NCT00888225

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Apr 27, 2009Estimated

Enrollment

205Actual

Phase

Not Applicable

Conditions

Lateral Epicondylitis

Interventions

Eccentric exercise
Concentric exercise

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Jan 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2009

Last Update Posted Date

Apr 27, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Uppsala UniversityOTHER

Collaborators

Name	Class
The Swedish Research Council	OTHER_GOV
Amersham Foundation	UNKNOWN
Uppsala County Council, Sweden	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. It is a common condition in the general population and often results in long-term sick-leave. The etiology is unknown. A large number of treatments have been tried but none is generally accepted. However, in Achilles tendinitis a new treatment has been shown effective. It consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). The latter is currently the most common treatment method.

This project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In addition, blood specimens for a number of neural peptides have been sampled. Moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (PET) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. The health economy of the two treatments will be investigated using data from this project and from available registers.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Eccentric exercise	Procedure	Eccentric exercise treatment performed at home with three sets of 15 repetitions daily	Eccentric exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain during dynamic and static muscle load		Month 0, 1, 2, 3, 6, 12

Secondary Outcomes

Measure	Description	Time Frame
Muscle strength and function		Month 0, 1, 2, 3, 6, 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt Svärdsudd, MD, PhD	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linköping University		Linköping		SE-58183	Sweden
Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24155873	Derived	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.
22066975	Derived

ID	Term
D013716	Tennis Elbow
D010146	Pain
D052256	Tendinopathy

ID	Term
D000070639	Elbow Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D000092464	Elbow Injuries