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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498533
Other study ID # 127/29.05.2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2014
Est. completion date January 31, 2018

Study information

Verified date August 2020
Source Haseki Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date January 31, 2018
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- aged between 18 and 65 years

- presence of elbow pain lasting for less than three months

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
forearm strap (counterforce brace)

Kinesio tape application


Locations

Country Name City State
Turkey University of Health Sciences, Istanbul Haseki Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (Immediately after treatment)
Primary 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 (Immediately after treatment)
Secondary Patient-Rated Tennis Elbow Evaluation Questionnaire The Turkish version of Patient-Rated Tennis Elbow Evaluation Questionnaire was used in the study. Patient-Rated Tennis Elbow Evaluation Questionnaire is a 15-item self-reported questionnaire to measure perceived pain and disability in people with tennis elbow.
The questionnaire is composed of three subscales: pain, usual activities and specific activities. Each of the items of the Patient-Rated Tennis Elbow Evaluation Questionnaire is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and 10 is 'worst ever' or 'unable to do'. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.
Patient-Rated Tennis Elbow Evaluation Questionnaire was evaluated at the baseline of the study, immediately after and one month later after treatment.
0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)
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Recruiting NCT01668862 - A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow) Phase 1/Phase 2
Withdrawn NCT04384809 - Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy Phase 4
Terminated NCT01668953 - Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) N/A