Back to resultsEfficiency of Kinesio Taping in Chronic Lateral Epicondylitis
Primary Purpose
Tendinopathy, Elbow
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tape
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy, Elbow focused on measuring Kinesio taping, lateral epicondylitis, residual effect
Eligibility Criteria
Inclusion Criteria:
- Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
- Unilateral elbow pain at least 12 weeks,
- Not received injection therapy to the elbow in the last six weeks,
- Not received a physical therapy program in the last three months,
- Presence of normal elbow radiographic findings,
- Normal elbow joint range of motion,
- Having no neurological deficits
Exclusion Criteria:
- Patients with degenerative joint disease,
- Radial tunnel syndrome,
- Cervical nerve root compression,
- Pain reflected from the neck, shoulders,
- Wrist, radiohumeral joint osteochondritis dissecans,
- Tendon rupture,
- Osteoporosis, Infection,
- Malignancy,
- Inflammatory disease,
- Pregnant women
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
true taping+ exercise
sham taping+exercise
Arm Description
The true taping method was applied to the first group according to the method determined by Kase. According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'. In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension. Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle. Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle.
In the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group. It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension.
Outcomes
Primary Outcome Measures
numerical rating scale
The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study. It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).
Secondary Outcome Measures
resisted muscle test evaluation
According to the Cyriax method, each joint tested was kept in the mid- range of motion, without allowing movement. Resistance was applied to the forearm distal to avoid muscle involvement other than that tested in pronation and supination, thus the wrist was prevented to be involved. Subsequently, the patients were asked to apply a maximum force for at least three seconds. Resisted wrist extension, third finger extension, elbow supination, and pronation were evaluated.
Maximal Isometric Handgrip Strength
The maximal isometric handgrip strength was measured in pounds using the Jamar hand dynamometer (Baseline® Hand Dynamometer - HiRes™ Gauge - ER™ 300 lbCapacity). Measurement was performed in two different positions, elbow at extension and 90° flexion. In the first position, the patient was in the sitting position, shoulder abducted to 0° and in neutral rotation, elbow position was at 90° flexion, the forearm was in neutral rotation and wrist was in the neutral position. In the second position, while the patient was standing, shoulder abducted to 0° and in neutral rotation, the elbow was in full extension, forearm and wrist were in the neutral position. The patient was asked to squeeze the dynamometer with full force for three seconds every 30 seconds. This procedure was repeated three times and the mean measurement values were obtained
The Patient-rated Tennis Elbow Evaluation(PRTEE)
The Patient-rated Tennis Elbow Evaluation (PRTEE) is a questionnaire with subscales related to pain and function, which is used to evaluate upper extremity functionality. It is specially prepared for patients with lateral epicondylitis.Scoring ranges from 0 (no pain/disability) to 100 (worst possible pain and disability). The total score can be 100 points maximum and low scores refer to better functionality.Turkish validity and reliability was proven by Altan et al.
36-Item Short-Form Health Survey (SF-36)
The SF-36 is valid and reliable for patients with chronic musculoskeletal disorders. The items include eight different domains that indicate physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worst quality of life) to 100 (the best quality of life).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04518527
Brief Title
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis
Official Title
Evaluation of Short-term and Residual Effects of Kinesio Taping in Chronic Lateral Epicondylitis: A Randomized, Double-blinded, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elif Balevi Batur
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 a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.
Detailed Description
Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom duration of at least 12 weeks. The study group received a true inhibitor Kinesio taping while the control group received sham taping for the first four weeks. In both groups, progressive stretching and strengthening exercises were given as a home program for 6 weeks. Patients were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation, maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short Form-36) by the first assessor who was blinded to taping types.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Elbow
Keywords
Kinesio taping, lateral epicondylitis, residual effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
true taping+ exercise
Arm Type
Active Comparator
Arm Description
The true taping method was applied to the first group according to the method determined by Kase. According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'. In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension. Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle. Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle.
Arm Title
sham taping+exercise
Arm Type
Placebo Comparator
Arm Description
In the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group. It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension.
Intervention Type
Device
Intervention Name(s)
Tape
Intervention Description
The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
Primary Outcome Measure Information:
Title
numerical rating scale
Description
The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study. It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
resisted muscle test evaluation
Description
According to the Cyriax method, each joint tested was kept in the mid- range of motion, without allowing movement. Resistance was applied to the forearm distal to avoid muscle involvement other than that tested in pronation and supination, thus the wrist was prevented to be involved. Subsequently, the patients were asked to apply a maximum force for at least three seconds. Resisted wrist extension, third finger extension, elbow supination, and pronation were evaluated.
Time Frame
1 year
Title
Maximal Isometric Handgrip Strength
Description
The maximal isometric handgrip strength was measured in pounds using the Jamar hand dynamometer (Baseline® Hand Dynamometer - HiRes™ Gauge - ER™ 300 lbCapacity). Measurement was performed in two different positions, elbow at extension and 90° flexion. In the first position, the patient was in the sitting position, shoulder abducted to 0° and in neutral rotation, elbow position was at 90° flexion, the forearm was in neutral rotation and wrist was in the neutral position. In the second position, while the patient was standing, shoulder abducted to 0° and in neutral rotation, the elbow was in full extension, forearm and wrist were in the neutral position. The patient was asked to squeeze the dynamometer with full force for three seconds every 30 seconds. This procedure was repeated three times and the mean measurement values were obtained
Time Frame
1 year
Title
The Patient-rated Tennis Elbow Evaluation(PRTEE)
Description
The Patient-rated Tennis Elbow Evaluation (PRTEE) is a questionnaire with subscales related to pain and function, which is used to evaluate upper extremity functionality. It is specially prepared for patients with lateral epicondylitis.Scoring ranges from 0 (no pain/disability) to 100 (worst possible pain and disability). The total score can be 100 points maximum and low scores refer to better functionality.Turkish validity and reliability was proven by Altan et al.
Time Frame
1 year
Title
36-Item Short-Form Health Survey (SF-36)
Description
The SF-36 is valid and reliable for patients with chronic musculoskeletal disorders. The items include eight different domains that indicate physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worst quality of life) to 100 (the best quality of life).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
Unilateral elbow pain at least 12 weeks,
Not received injection therapy to the elbow in the last six weeks,
Not received a physical therapy program in the last three months,
Presence of normal elbow radiographic findings,
Normal elbow joint range of motion,
Having no neurological deficits
Exclusion Criteria:
Patients with degenerative joint disease,
Radial tunnel syndrome,
Cervical nerve root compression,
Pain reflected from the neck, shoulders,
Wrist, radiohumeral joint osteochondritis dissecans,
Tendon rupture,
Osteoporosis, Infection,
Malignancy,
Inflammatory disease,
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IŞIL S YENİCE BALEVİ
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BELGİN KARAOĞLAN
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
NAGİHAN ACET
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Learn more about this trial
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis
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