Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
1 other identifier
interventional
72
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedAugust 4, 2020
August 1, 2020
3.2 years
July 15, 2020
August 2, 2020
Conditions
Keywords
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 COMPARATORThe 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.
KT (kinesio tape) group
ACTIVE COMPARATORIn 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.
Interventions
Eligibility Criteria
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)
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.
PMID: 11869609RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Öznur Çelik, MD
University of Health Sciences, Istanbul Haseki Training and Research Hospital
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
- 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