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

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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: Kinesio Tape; Drug: oral naproxen

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Basak Mansiz-Kaplan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Kinesio Tape; 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.; Drug: oral naproxen; 750 mg/day oral naproxen is administered for 10 days.
Active Comparator: NSAID; 750 mg/day oral naproxen is administered for 10 days.	Drug: oral naproxen; 750 mg/day oral naproxen is administered for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Pre-treatment, 2nd and 6th weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-treatment, 2nd and 6th weeks after treatment
Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks	Using the musculoskeletal ultrasonography to measure CET thickness.	Pre-treatment, 2nd and 6th weeks after treatment.
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)	Pre-treatment, 2nd and 6th weeks after treatment.

Collaborators and Investigators

• Sponsor: Ankara Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): July 7, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: E10654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No