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Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Tape
oral naproxen
Sponsored by
Ankara Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the presence of pain in the lateral elbow region at least for three months
  • tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors.

Exclusion Criteria:

  • bilateral LE
  • presence of trigger point in the extensor muscles of the forearm
  • history of proximal upper extremity or neck symptoms
  • cervical pathology
  • central or peripheral neurologic disease
  • nerve entrapment syndromes
  • surgical treatments for LE
  • presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal disorders, using anticoagulant)
  • trauma history of upper extremity
  • previous steroid injection around the lateral epicondyle
  • physical therapy targeted for LE in the past 6 months
  • presence of structures like fibrous bands, arc or recurrent radial artery around the radial nerve that may cause the entrapment of nerve
  • pregnancy and having any systemic disease that may cause swelling at nerves such as diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.

Sites / Locations

  • Basak Mansiz-Kaplan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio tape plus NSAID

NSAID

Arm Description

Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.

750 mg/day oral naproxen is administered for 10 days.

Outcomes

Primary Outcome Measures

Change from baseline of pain on 2nd and 6th weeks
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).

Secondary Outcome Measures

Change from baseline of functional status on 2nd and 6th weeks
Using Patient-Rated Forearm Evaluation Questionnare (PRTEQ) to evaluate functional status. The PRTEQ is a 15-item questionnaire which has two subscale: pain subscale and function subscale.. It is shown to be a reliable and valid tool for measuring pain and function in patients with LE. Pain subscale is comprised of 5 questions, and function subscale is comprised of 10 questions. The total score is calculated by the sum of these two subscales.
Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks
Using the musculoskeletal ultrasonography to measure CET thickness.
Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks
Using the musculoskeletal ultrasonography to measure radial nerve cross-sectional area. Measurements of radial nerve CSA is taken from three different levels: spiral grove, just before bifurcation and between the two heads of supinator muscle (CSA)

Full Information

First Posted
January 3, 2019
Last Updated
September 19, 2019
Sponsor
Ankara Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03794219
Brief Title
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?
Official Title
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
July 7, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. LE is mostly the result of the overuse and repetitive movements of wrists and hands because of occupational or recreational activities. Diagnosis depends on clinical symptoms, history and physical examination including manual provocation tests. Magnetic resonance imaging, ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not response to conservative treatments. It is known that the radial nerve cross sectional-areas (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal. There is insufficient evidence to prove the superiority of any of conservative treatments to the others in patients with LE. The literature indicates that Kinesio taping decreases pain intensity, recovers grip strength, and improves functional status in patients with LE. The investigators design a randomized, single-blind, controlled trail to evaluate the effects of Kinesio taping both clinical and using ultrasonography.
Detailed Description
After obtaining written informed consent, patients of clinically diagnosed with LE are randomized into intervention and control group. To all patients, activity modification is suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6 sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs. The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio tape plus NSAID
Arm Type
Experimental
Arm Description
Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.
Arm Title
NSAID
Arm Type
Active Comparator
Arm Description
750 mg/day oral naproxen is administered for 10 days.
Intervention Type
Other
Intervention Name(s)
Kinesio Tape
Intervention Description
To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.
Intervention Type
Drug
Intervention Name(s)
oral naproxen
Intervention Description
750 mg/day oral naproxen is administered for 10 days.
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd and 6th weeks
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).
Time Frame
Pre-treatment, 2nd and 6th weeks after treatment
Secondary Outcome Measure Information:
Title
Change from baseline of functional status on 2nd and 6th weeks
Description
Using Patient-Rated Forearm Evaluation Questionnare (PRTEQ) to evaluate functional status. The PRTEQ is a 15-item questionnaire which has two subscale: pain subscale and function subscale.. It is shown to be a reliable and valid tool for measuring pain and function in patients with LE. Pain subscale is comprised of 5 questions, and function subscale is comprised of 10 questions. The total score is calculated by the sum of these two subscales.
Time Frame
Pre-treatment, 2nd and 6th weeks after treatment
Title
Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks
Description
Using the musculoskeletal ultrasonography to measure CET thickness.
Time Frame
Pre-treatment, 2nd and 6th weeks after treatment.
Title
Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks
Description
Using the musculoskeletal ultrasonography to measure radial nerve cross-sectional area. Measurements of radial nerve CSA is taken from three different levels: spiral grove, just before bifurcation and between the two heads of supinator muscle (CSA)
Time Frame
Pre-treatment, 2nd and 6th weeks 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: the presence of pain in the lateral elbow region at least for three months tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors. Exclusion Criteria: bilateral LE presence of trigger point in the extensor muscles of the forearm history of proximal upper extremity or neck symptoms cervical pathology central or peripheral neurologic disease nerve entrapment syndromes surgical treatments for LE presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal disorders, using anticoagulant) trauma history of upper extremity previous steroid injection around the lateral epicondyle physical therapy targeted for LE in the past 6 months presence of structures like fibrous bands, arc or recurrent radial artery around the radial nerve that may cause the entrapment of nerve pregnancy and having any systemic disease that may cause swelling at nerves such as diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.
Facility Information:
Facility Name
Basak Mansiz-Kaplan
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

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Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?

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