Health TrialsbyHealthPanel

Kinesio Taping for Lacertus Syndrome

ConditionLacertus Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArab American University (Palestine)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kinesio Taping

    Device

    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.

  • Standardized Conservative Treatment

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Kinesio Taping Plus Conservative TreatmentExperimental treatment 2 interventions
Group B: Conservative Treatment AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Retention Rate

The proportion of randomized participants who complete the full 4-week intervention period and the final outcome assessment. Calculated as the number of participants completing the study divided by the total number of randomized participants, expressed as a percentage.

Time frame
4 weeks after baseline
2

Recruitment Rate

The number of eligible participants successfully enrolled into the study per month during the 6-month recruitment period. This will be calculated as the total number of randomized participants divided by the number of months of active recruitment.

Time frame
Through study completion, approximately 6 months
3

Adherence Rate to Kinesio Taping Protocol

The proportion of prescribed Kinesio Tape applications that were completed by participants in the experimental group, as documented in standardized tape application logs. Calculated as the number of actual tape applications divided by the number of expected applications over the 4-week intervention period, expressed as a percentage.

Time frame
4 weeks after baseline

Secondary outcomes

1

Change in Pain Intensity (Numeric Pain Rating Scale)

Change in pain intensity from baseline to 4 weeks measured using the Numeric Pain Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). A negative change score indicates improvement (pain reduction). The minimal clinically important difference is 2 points.

Time frame
Baseline and 4 weeks
2

Change in Upper Extremity Function (QuickDASH)

Change in upper extremity function from baseline to 4 weeks measured using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), Arabic validated version. The QuickDASH is an 11-item questionnaire scored from 0 (no disability) to 100 (most severe disability). A negative change score indicates improvement (reduced disability). The minimal clinically important difference is 8 to 16 points.

Time frame
Baseline and 4 weeks
3

Change in Grip Strength

DescriptionChange in hand grip strength from baseline to 4 weeks measured using a calibrated hydraulic hand dynamometer following standardized protocols of the American Society of Hand Therapists. Measured in kilograms. The average of three trials with 30-second rest intervals will be recorded. A positive change score indicates improvement (increased strength)

Time frame
Baseline and 4 weeks
4

Change in Tip Pinch Strength

Change in tip pinch strength from baseline to 4 weeks measured using a calibrated pinch gauge following standardized protocols of the American Society of Hand Therapists. Measured in kilograms. The average of three trials with 30-second rest intervals will be recorded

Time frame
Baseline and 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arab American University (Palestine)

Lead sponsor

Source ClinicalTrials.gov

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