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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Kinesio Taping Plus Conservative Treatment
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.
干预措施: Kinesio Taping (Device)
Kinesio Taping Plus Conservative Treatment
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.
干预措施: Standardized Conservative Treatment (Behavioral)
Conservative Treatment Alone
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.
干预措施: Standardized Conservative Treatment (Behavioral)
结局指标
主要结局
Retention Rate
时间窗: 4 weeks after baseline
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.
Recruitment Rate
时间窗: Through study completion, approximately 6 months
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.
Adherence Rate to Kinesio Taping Protocol
时间窗: 4 weeks after baseline
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.
次要结局
- 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)
- Change in Palmar (Three-Jaw Chuck) Pinch Strength(Baseline and 4 weeks)
研究者
Husam Taha
Principal Investigator
Arab American University (Palestine)