NCT04498533

Brief Summary

Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain and sensitivity in the lateral elbow region. The aim of the study was to find out about is there any difference between the effects of traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis. Therefore, the forearm counterforce brace, which was widely used in daily clinical practice for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping which has become increasingly popular. The study investigated and compared the effects of the two interventions (the forearm counterforce brace and kinesio tape) on pain severity, functional status and disability of patients with lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

July 15, 2020

Last Update Submit

August 2, 2020

Conditions

Keywords

Lateral epicondylitisforearm counterforce bracekinesio taping

Outcome Measures

Primary Outcomes (2)

  • Pain Pressure Threshold

    The tenderness on the lateral aspect of elbow was evaluated with pain pressure threshold measurements. An algometer device was used to measure pain pressure threshold. Pain pressure threshold measurements were performed at the baseline of the study, immediately after and one month later after treatment.

    Baseline to 3 week (İmmediately after treatment)

  • Grip Strength

    Affected upper limb function was evaluated with maximal hand grip strength. Grip strength was measured with a hydraulic hand dynamometer. Grip strength was evaluated at the baseline of the study, immediately after and one month later after treatment.

    Baseline to 3 week (İmmediately after treatment)

Secondary Outcomes (1)

  • Patient-Rated Tennis Elbow Evaluation Questionnaire

    0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)

Study Arms (2)

B (brace) group

ACTIVE COMPARATOR

The patients in the B group were informed about the application of the forearm strap (counterforce brace). Patients were advised to wear the counterforce brace for three weeks continuously.

Other: forearm strap (counterforce brace)

KT (kinesio tape) group

ACTIVE COMPARATOR

In the KT group, a standard 2-inch (5 cm) Kinesio®Tex tape (Kinesio Holding Corporation, Albuquerque, New Mexico, USA) was used with techniques of muscle inhibition and fascia correction. Kinesio tape was applied once a week for four weeks.

Other: Kinesio tape application

Interventions

KT (kinesio tape) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 18 and 65 years
  • presence of elbow pain lasting for less than three months

You may not qualify if:

  • history of acute trauma or fracture on forearm
  • congenital or acquired elbow deformities
  • demyelinating diseases
  • patients who had diagnosed as fibromyalgia
  • presence of skin lesion on lateral aspect of the elbow
  • presence of rheumatic disease
  • presence of systemic infection
  • presence of pregnancy
  • presence of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Istanbul Haseki Training and Research Hospital

Istanbul, 34130, Turkey (Türkiye)

Location

Related Publications (1)

  • Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Öznur Çelik, MD

    University of Health Sciences, Istanbul Haseki Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome-assessing investigator (O. Celik) was blinded to the randomization. All study participants were assessed by the blinded investigator (O.Celik). Follow-up measurements were performed immediately after and one month later after treatment. All treatment sessions were applied by the same investigator (S. Sencan), who was not blinded to the study groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A prospective, randomized and assessor-blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2020

First Posted

August 4, 2020

Study Start

June 1, 2014

Primary Completion

July 31, 2017

Study Completion

January 31, 2018

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations