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

NCT03794219 | Completed

• 1 other identifier: E10654
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline of functional status 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.

• Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks

  Pre-treatment, 2nd and 6th weeks after treatment.

Study Arms (2)

Kinesio tape plus NSAID

EXPERIMENTAL

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; Drug: oral naproxen

NSAID

ACTIVE COMPARATOR

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

Drug: oral naproxen

Interventions

Kinesio Tape OTHER

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.

Kinesio tape plus NSAID

oral naproxen DRUG

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

Kinesio tape plus NSAID; NSAID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Education and Research Hospital: lead

Study Sites (1)

Basak Mansiz-Kaplan

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Athletic Tape; Naproxen

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: January 7, 2019
• Primary Completion: July 7, 2019
• Study Completion: August 1, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

TU (1)