Kinesio Taping for Lacertus Syndrome

Background and Rationale

Lacertus syndrome is a dynamic compression of the median nerve at the lacertus fibrosus (bicipital aponeurosis) in the proximal forearm. It is an increasingly recognized but often underdiagnosed cause of forearm pain, paresthesia, and functional disability. Up to 20% of patients presenting with signs of median nerve involvement may have compression at this level. The condition is frequently misdiagnosed as carpal tunnel syndrome or other nerve entrapment neuropathies due to overlapping clinical features.

Diagnosis relies on clinical examination including Hagert's triad (localized tenderness over the lacertus fibrosus, reproduction of symptoms with resisted forearm pronation, and reproduction of symptoms with resisted elbow flexion) and the Orthogonal Kinesiotaping Test (OKT), which has demonstrated 95% sensitivity and 89% specificity. Electrodiagnostic studies (electromyography and nerve conduction studies) are used to confirm median nerve involvement and exclude alternative diagnoses such as cervical radiculopathy.

Surgical release of the lacertus fibrosus is the current standard of care and has demonstrated high success rates. However, surgery may not be accessible, feasible, or preferred by all patients, particularly in resource-constrained healthcare systems. Despite this need, there is a critical gap in the evidence base for conservative management of lacertus syndrome. No high-quality randomized controlled trials have evaluated non-surgical interventions specifically designed for this condition.

Kinesio Taping is a therapeutic technique with a growing evidence base in musculoskeletal and neurological rehabilitation. Its proposed mechanisms of action include cutaneous mechanoreceptor stimulation, fascial decompression, proprioceptive enhancement, and neuromuscular re-education. Systematic reviews and meta-analyses have demonstrated that Kinesio Taping can reduce pain and improve function in carpal tunnel syndrome, another median nerve entrapment neuropathy, providing a rationale for investigating its application in lacertus syndrome.

Theoretical Framework

This study will be guided by the International Classification of Functioning, Disability and Health (ICF) framework, specifically the Brief ICF Core Set for Hand Conditions. Within this framework, lacertus syndrome will be conceptualized as a health condition leading to impairments in body functions (pain, muscle weakness, altered sensation) that affect activities (fine hand use, hand and arm use) and participation (self-care, domestic life, work). The Kinesio Taping intervention will be positioned as a facilitator within the environmental factors domain. ICF codes targeted will include b280 (sensation of pain), b730 (muscle power functions), and b265 (touch function) within body functions; s730 (structure of the upper extremity), specifically the lacertus fibrosus, within body structures; d440, d445, d5, d6, and d8 within activities and participation; and e355 (health professionals) within environmental factors.

Study Design and Randomization

This study will be a pilot, single-blind, parallel-group randomized controlled trial with a 1:1 allocation ratio, designed following SPIRIT 2013 guidelines and reported according to the CONSORT extension for pilot and feasibility trials.

A total of 30 participants (15 per group) will be enrolled. This target follows established guidance for pilot and feasibility studies, which recommends samples of approximately 24 to 50 participants in order to estimate the standard deviation of candidate outcome measures with reasonable precision for planning a future definitive trial. The study will not be powered to detect statistically significant differences between groups; its purpose is to establish feasibility and to generate preliminary parameter estimates.

Participants will be recruited from private clinics, medical centers, and hospitals in the central and northern governorates of the West Bank, Palestine. Potential participants will be identified by treating clinicians during routine clinical care and referred to the principal investigator, who will screen for eligibility, explain the study, and obtain written informed consent prior to baseline assessment.

Participants will be allocated using a covariate-adaptive minimization procedure (Pocock and Simon method) implemented through validated randomization software. The algorithm will balance age (40 years or younger versus older than 40), gender, symptom duration (4 to 12 weeks versus more than 12 weeks), baseline pain intensity (Numeric Pain Rating Scale score of 5 or less versus greater than 5), and recruitment site. A biased coin probability of 0.75 will favor the allocation that minimizes imbalance while maintaining adequate randomness. The randomization sequence will be generated and maintained by an independent statistician, and allocation concealment will be ensured through a secure, password-protected web-based system. The outcome assessor will be blinded to group allocation; participants will be instructed to wear long sleeves during assessments and to avoid discussing their treatment with the assessor.

Interventions

Experimental Group: Therapeutic Kinesio Taping applied with 25 to 50 percent stretch over the lacertus fibrosus region using 5-centimeter-width elastic therapeutic tape, following standardized anatomical landmarks (biceps tendon/lacertus fibrosus region, proximal pronator teres, and medial forearm fascia). The initial application will be performed by a trained therapist; participants will then be trained for home reapplication through hands-on demonstration, printed instructions, and an instructional video. Tape will be reapplied every 2 to 3 days for 4 weeks, with adherence monitored using tape application logs. This group will also receive the standardized conservative treatment described below.

Control Group: A standardized conservative treatment protocol consisting of a 30-minute educational session (anatomy, pathophysiology, activity modification, and ergonomic principles), a structured home exercise program (median nerve gliding exercises, tendon gliding exercises, and forearm muscle stretching, each performed twice daily), activity modification guidelines (including avoidance of sustained repetitive pronation and scheduled breaks during repetitive tasks), and weekly telephone follow-up. All materials will be provided in Arabic.

Both groups will receive the conservative treatment, ensuring that any observed differences are attributable to the addition of Kinesio Taping.

Outcome Assessment

Outcomes will be assessed at two time points: at baseline, following enrollment and prior to group allocation, and at the end of the 4-week intervention period. The primary outcomes will be feasibility measures, comprising recruitment rate, retention rate, and adherence to the Kinesio Taping protocol. The secondary outcomes will be the Numeric Pain Rating Scale, the QuickDASH, grip strength, and tip, key, and palmar pinch strength.

Data Analysis

Descriptive statistics will summarize feasibility outcomes and baseline characteristics. For secondary effectiveness outcomes, analysis will follow the intention-to-treat principle. Change scores from baseline to 4 weeks will be compared between groups using independent t-tests or Mann-Whitney U tests depending on data distribution (assessed by the Shapiro-Wilk test). Effect sizes (Cohen's d) with 95% confidence intervals will be calculated. A significance level of 0.05 will be used. Multiple imputation with 20 imputed datasets will handle missing data, with sensitivity analyses including complete case analysis, per-protocol analysis, and pattern mixture models.

Safety Monitoring

All participants will undergo skin patch testing prior to the first tape application. Adverse skin reactions will be classified using a standardized four-grade scale and managed per a predefined protocol. Participants will perform daily self-monitoring, with weekly clinical assessments by research staff. All adverse events will be documented and reported to the Institutional Review Board according to Good Clinical Practice guidelines.

Ethical Considerations

This study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board of the Arab American University of Palestine - Ramallah (approval number R-2026/A/15/N, approved February 3, 2026). Approval is valid for one year from the date of approval, and the Board requires notification of any modification to the approved protocol. All participants will provide written informed consent in Arabic prior to enrollment, after being informed of the study aims, procedures, potential risks and benefits, the voluntary nature of participation, and the right to withdraw at any time without penalty. All data will be anonymized to preserve participant confidentiality.