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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04518527
Other study ID # GaziU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date July 1, 2017

Study information

Verified date February 2017
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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

Study Design


Intervention

Device:
Tape
The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Elif Balevi Batur

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1 year
Secondary 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. 1 year
Secondary 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 1 year
Secondary 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. 1 year
Secondary 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). 1 year
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