Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis (Tennis Elbow)
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
forearm strap (counterforce brace)
Kinesio tape application
Sponsored by
About this trial
This is an interventional other trial for Lateral Epicondylitis (Tennis Elbow) focused on measuring Lateral epicondylitis, forearm counterforce brace, kinesio taping
Eligibility Criteria
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
Sites / Locations
- University of Health Sciences, Istanbul Haseki Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
B (brace) group
KT (kinesio tape) group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04498533
First Posted
July 15, 2020
Last Updated
August 2, 2020
Sponsor
Haseki Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04498533
Brief Title
Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
Official Title
Bracing or Kinesio Taping in The Management of Lateral Epicondylitis: a Randomized Single-blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haseki Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis (Tennis Elbow)
Keywords
Lateral epicondylitis, forearm counterforce brace, kinesio taping
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized and assessor-blinded study
Masking
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.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B (brace) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
KT (kinesio tape) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
forearm strap (counterforce brace)
Intervention Type
Other
Intervention Name(s)
Kinesio tape application
Primary Outcome Measure Information:
Title
Pain Pressure Threshold
Description
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.
Time Frame
Baseline to 3 week (İmmediately after treatment)
Title
Grip Strength
Description
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.
Time Frame
Baseline to 3 week (İmmediately after treatment)
Secondary Outcome Measure Information:
Title
Patient-Rated Tennis Elbow Evaluation Questionnaire
Description
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.
Time Frame
0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Öznur Çelik, MD
Organizational Affiliation
University of Health Sciences, Istanbul Haseki Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences, Istanbul Haseki Training and Research Hospital
City
İstanbul
ZIP/Postal Code
34130
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11869609
Citation
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.
Results Reference
result
Learn more about this trial
Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
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