Bracing or Kinesio Taping in The Management of Lateral Epicondylitis

Sponsor

Haseki Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04498533

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lateral Epicondylitis (Tennis Elbow)	Other: forearm strap (counterforce brace) Other: Kinesio tape application	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective, randomized and assessor-blinded studyA prospective, randomized and assessor-blinded study

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Other

Official Title:

Bracing or Kinesio Taping in The Management of Lateral Epicondylitis: a Randomized Single-blinded Trial

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: B (brace) group 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)
Active Comparator: KT (kinesio tape) group 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

Arm

Intervention/Treatment

Active Comparator: B (brace) group

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)

Active Comparator: KT (kinesio tape) group

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

Outcome Measures

Primary Outcome Measures

Pain Pressure Threshold [Baseline to 3 week (İmmediately after treatment)]
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.
Grip Strength [Baseline to 3 week (İmmediately after treatment)]
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.

Secondary Outcome Measures

Patient-Rated Tennis Elbow Evaluation Questionnaire [0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Sciences, Istanbul Haseki Training and Research Hospital	İstanbul		Turkey	34130

Sponsors and Collaborators

Haseki Training and Research Hospital

Investigators

Principal Investigator: Öznur Çelik, MD, University of Health Sciences, Istanbul Haseki Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Öznur Çelik, Principal Investigator, Haseki Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04498533

Other Study ID Numbers:

127/29.05.2014

First Posted:

Aug 4, 2020

Last Update Posted:

Aug 4, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Öznur Çelik, Principal Investigator, Haseki Training and Research Hospital

Lateral epicondylitis

forearm counterforce brace

kinesio taping

Additional relevant MeSH terms:

Tennis Elbow

Study Results

No Results Posted as of Aug 4, 2020