Bracing or Kinesio Taping in The Management of Lateral Epicondylitis

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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Other: forearm strap (counterforce brace); Other: Kinesio tape application

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34130
    • University of Health Sciences, Istanbul Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): January 31, 2018

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: kinesio taping; Lateral epicondylitis; forearm counterforce brace
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 127/29.05.2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No