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NOT YET RECRUITING

NCT07404917

Kinesio Taping for Lacertus Syndrome

Sponsor: Arab American University (Palestine)

View on ClinicalTrials.gov

Summary

Background: Lacertus syndrome is a condition in which the median nerve is compressed at the lacertus fibrosus in the proximal forearm, leading to pain, numbness, weakness, and reduced hand function. The current standard treatment is surgical release. However, surgery may not be accessible or preferred by all patients, particularly in healthcare settings with limited resources. There is very little research on non-surgical treatment options for this condition. Purpose: The purpose of this pilot study is to evaluate the feasibility and preliminary effectiveness of adding Kinesio Taping to a standardized conservative treatment program for adults diagnosed with lacertus syndrome. Design: This is a single-blind, parallel-group, pilot randomized controlled trial. Thirty adults aged 18 to 65 years with a confirmed diagnosis of lacertus syndrome will be randomly assigned to one of two groups: (1) an experimental group receiving therapeutic Kinesio Taping applied over the lacertus fibrosus in addition to standardized conservative treatment, or (2) a control group receiving standardized conservative treatment alone. The conservative treatment includes patient education, nerve gliding exercises, tendon gliding exercises, stretching, and activity modification. The intervention period is 4 weeks. Outcomes: The primary outcomes are feasibility measures including recruitment rate, retention rate, and adherence to the Kinesio Taping protocol. Secondary outcomes include pain intensity measured by the Numeric Pain Rating Scale, upper extremity function measured by the Quick Disabilities of the Arm, Shoulder and Hand questionnaire, grip strength measured by a hydraulic hand dynamometer, and pinch strength measured by a calibrated pinch gauge. All secondary outcomes are assessed at baseline and at 4 weeks. Significance: This pilot study will provide essential data on the feasibility of conducting a Kinesio Taping intervention trial in the West Bank, Palestine, and will generate preliminary estimates of treatment effects to inform the design of a future definitive randomized controlled trial.

Official title: The Effectiveness of Conservative Treatment With Added Kinesio Taping in Decreasing Pain and Improving Hand Function and Grip Strength Among Individuals With Lacertus Syndrome: A Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-15

Completion Date

2026-12-01

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Lacertus Syndrome

Interventions

DEVICE

Kinesio Taping

Therapeutic elastic Kinesio Tape (5 cm width) applied with 25 to 50 percent stretch over the lacertus fibrosus in the proximal forearm. The tape is applied following standardized anatomical landmarks: anchor placed without stretch over the medial epicondyle region, therapeutic zone applied with stretch directly over the lacertus fibrosus, and terminal anchor placed without stretch over the proximal forearm. The initial application is performed by a trained therapist in the clinic. Participants are trained for home reapplication through hands-on demonstration, printed step-by-step instructions, and an instructional video. Tape is reapplied every 2 to 3 days for a total of 4 weeks. Adherence is monitored using tape application logs.

BEHAVIORAL

Standardized Conservative Treatment

A 4-week standardized conservative treatment protocol consisting of four components: (1) Education: a 30-minute session covering lacertus syndrome anatomy and pathophysiology, activity modification guidelines, and ergonomic principles, with written materials provided in Arabic; (2) Exercise program: median nerve gliding exercises (3 sets of 10 repetitions, twice daily), tendon gliding exercises for flexor tendons (3 sets of 10 repetitions, twice daily), and forearm muscle stretching (30-second holds, 3 repetitions, twice daily), with access to an instructional video; (3) Activity modification: avoidance of repetitive pronation for more than 30 minutes continuously, regular breaks every 30 minutes during repetitive activities, use of ergonomic tools, and specific workplace modifications; (4) Follow-up: standardized weekly telephone check-ins to monitor compliance and address questions, with exercise logs for tracking adherence.

Inclusion Criteria: * Adults aged 18 to 65 years * Confirmed clinical diagnosis of lacertus syndrome established by a physician specializing in orthopedics, physical medicine, or neurology following a standardized multi-modal diagnostic protocol * Positive Hagert's triad, defined as the presence of all three of the following: (1) localized tenderness upon palpation of the lacertus fibrosus, (2) reproduction of symptoms during resisted forearm pronation, and (3) reproduction of symptoms during resisted elbow flexion * Positive Orthogonal Kinesiotaping Test (OKT) conducted by a trained examiner * Neurological evaluation excluding other median nerve entrapment syndromes such as carpal tunnel syndrome * Electrodiagnostic studies (electromyography and nerve conduction studies) confirming median nerve involvement and ruling out alternative sources of neural compromise including cervical radiculopathy * Symptom duration of at least 4 weeks to ensure subacute to chronic presentation * Willing and able to provide written informed consent * Able to attend all scheduled study visits and follow the home treatment protocol Exclusion Criteria: * Previous surgery for lacertus syndrome or any other median nerve entrapment condition in the affected arm * Known allergy to Kinesio tape or adhesive materials * Dermatological condition at the intended site of tape application (e.g., open wounds, active skin infection, eczema, psoriasis) * Neurological disorder that could confound the assessment of lacertus syndrome symptoms (e.g., multiple sclerosis, diabetic peripheral neuropathy, cervical radiculopathy) * Musculoskeletal disorder in the affected upper extremity that could confound symptom assessment (e.g., lateral or medial epicondylitis, shoulder impingement, rheumatoid arthritis affecting the hand or wrist) * Current pregnancy * Receipt of corticosteroid injection for lacertus syndrome within the past 3 months * Current use of other therapeutic taping on the affected arm * Cognitive impairment that would prevent understanding of study procedures or self-application of Kinesio tape

Locations (1)

Elite for special orthopedic surgery

Ramallah, Palestinian Territories