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Clinical Trials/NCT03794219
NCT03794219
Completed
Not Applicable

Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.

Ankara Education and Research Hospital1 site in 1 country80 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Kinesio Tape
Conditions
Lateral Epicondylitis
Sponsor
Ankara Education and Research Hospital
Enrollment
80
Locations
1
Primary Endpoint
Change from baseline of pain on 2nd and 6th weeks
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
August 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ankara Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Basak Mansiz-Kaplan

Principal Investigator of Department of Physical Medicine and Rehabilitation

Ankara Education and Research Hospital

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

Arms & Interventions

Kinesio tape plus NSAID

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.

Intervention: Kinesio Tape

Kinesio tape plus NSAID

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.

Intervention: oral naproxen

NSAID

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

Intervention: oral naproxen

Outcomes

Primary Outcomes

Change from baseline of pain on 2nd and 6th weeks

Time Frame: Pre-treatment, 2nd and 6th weeks after treatment

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 Outcomes

  • Change from baseline of functional status on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment)
  • Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment.)
  • Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment.)

Study Sites (1)

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