PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Michael Fredericson, MD15 enrolled

Overview

This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS). CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR. The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.

1. Study team recruits patients with severe CTS who meet inclusion and exclusion criteria in an outpatient hand surgery clinic. Patients will be consented by the research team if the patient agrees to participate in the research study. 2. This will be a single blinded study, and participants will have an equal chance to be placed in either group. Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups: those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP. All participants will have a pre-operative electromyography/nerve conduction study (EMG/NCS). 3. Primary outcome measures (BCTQ and grip strength), and secondary outcome measures (PROMIS; 2 point discrimination - thumb, index finger and middle finger; key pinch; 3 finger pinch; and EMG/NCS results) will be collected and stored in REDCap at initial visit. BCTQ and PROMIS will actually be available online for patient to complete at the patient's convenience. 4. Patients will undergo CTR with or without adjuvant PRP (based on assigned study group). Patients will not know which group the subject is in (single blinded). 5. BCTQ and PROMIS will be collected online at 3 months and 6 months post-operatively. EMG/NCS will only be performed preoperatively and at 6 months post-operatively in the Sports Medicine clinic. At the 6-month visit, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch. 6. The investigators will store data in REDCap. 7. Data will be analyzed with the assistance of our biostatistician, and results will be written up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Carpal Tunnel Syndrome PRP

Interventions

Carpal Tunnel Release with Platelet-Rich PlasmaDEVICE

CTR is performed with adjuvant PRP placed intra-operatively.

Carpal Tunnel Release without Platelet-Rich PlasmaPROCEDURE

CTR is performed without adjuvant PRP placed intra-operatively.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult age 18 years and up. 2. Diagnosed with severe CTS based on EMG/NCS, meaning those with evidence of axonal loss (absent or low amplitude median sensory nerve action potential and/or absent or low amplitude median motor nerve action potential and/or evidence of abnormal spontaneous activity, reduced recruitment, or motor unit action potential changes on needle EMG of median innervated muscles). Exclusion Criteria: 1. Younger than age 18 years (minor status). 2. Diagnosed with concomitant peripheral neuropathy. 3. Previous CTR on the affected side. 4. Have contraindications to PRP (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, septicemia, local infection at site of procedure, consistent use of NSAIDs within 48 hours of procedure, steroid injection at treatment site within 1 month, systemic use of steroids within 2 weeks, tobacco use, recent fever or illness, or cancer).

Locations (1)

Stanford University

Redwood City, California, United States

Outcomes

Primary Outcomes

Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe.

Time frame: up to 1 month pre-op

Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

Time frame: 3 months post-op

Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire

Time frame: 6 months post-op

Grip Strength

Measured with a dynamometer.

Time frame: up to 1 month pre-op

Grip Strength

Measured with a dynamometer.

Time frame: 6 months post-op

Secondary Outcomes

Patient-Reported Outcomes Measurement Information System (PROMIS)

A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function.

Data from ClinicalTrials.gov

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