Kinesio Taping for Lacertus Syndrome

NCT07404917 | Not Yet Recruiting

• 1 other identifier: R-2026/A/15/N
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lacertus Syndrome

Keywords

Lacertus syndrome; Median nerve compression; Forearm pain; Kinesio Taping; Conservative treatment; Nerve gliding exercises; Rehabilitation; Feasibility study; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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.

  4 weeks after baseline

• 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.

  Through study completion, approximately 6 months

• 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.

  4 weeks after baseline

Secondary Outcomes (6)

• Change in Pain Intensity (Numeric Pain Rating Scale)

  Baseline and 4 weeks

• Change in Upper Extremity Function (QuickDASH)

  Baseline and 4 weeks

• Change in Grip Strength

  Baseline and 4 weeks

• Change in Tip Pinch Strength

  Baseline and 4 weeks

• Change in Key (Lateral) Pinch Strength

  Baseline and 4 weeks

Study Arms (2)

Kinesio Taping Plus Conservative Treatment

EXPERIMENTAL

Participants in this arm will receive therapeutic Kinesio Taping applied with 25 to 50 percent stretch over the lacertus fibrosus region, reapplied every 2 to 3 days for 4 weeks. In addition, participants will receive the standardized conservative treatment protocol including patient education, median nerve gliding exercises, tendon gliding exercises, forearm stretching exercises, and activity modification guidelines.

Device: Kinesio Taping; Behavioral: Standardized Conservative Treatment

Conservative Treatment Alone

ACTIVE COMPARATOR

Participants in this arm will receive the standardized conservative treatment protocol alone, consisting of a 30-minute educational session about lacertus syndrome, a structured home exercise program (median nerve gliding exercises, tendon gliding exercises, and forearm muscle stretching performed twice daily), activity modification guidelines, and weekly telephone follow-up. All educational materials will be provided in Arabic.

Behavioral: Standardized Conservative Treatment

Interventions

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.

Kinesio Taping Plus Conservative Treatment

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.

Conservative Treatment Alone; Kinesio Taping Plus Conservative Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Elite for special orthopedic surgery

Ramallah, Palestinian Territories

Location

Related Publications (3)

• Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.

  PMID: 27842937 BACKGROUND

• Apard T, Ferembach B, Martinel V. Lacertus Syndrome Diagnosis With the Orthogonal Kinesiotaping Test. Plast Reconstr Surg Glob Open. 2025 Apr 23;13(4):e6728. doi: 10.1097/GOX.0000000000006728. eCollection 2025 Apr.

  PMID: 40270558 BACKGROUND

• Hagert E. Clinical diagnosis and wide-awake surgical treatment of proximal median nerve entrapment at the elbow: a prospective study. Hand (N Y). 2013 Mar;8(1):41-6. doi: 10.1007/s11552-012-9483-4.

  PMID: 24426891 BACKGROUND

Central Study Contacts

Husam Taha

CONTACT

+970598265150; husam.taha@aaup.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 12, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months after publication of the main study results and available for 5 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal for use of the data. Proposals should be directed to the principal investigator (Husam Omar Taha) at the Arab American University of Palestine. Requestors will be required to sign a data access agreement.

Locations

PA (1)