PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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). 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. 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). BCTQ and PROMIS will be collected online at 3 months, 6 months, and 12 months post-operatively. EMG/NCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic. At these visits, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch. The investigators will store data in REDCap. Data will be analyzed with the assistance of our biostatistician, and results will be written up.

Official Title
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Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome, PRP

Intervention / Treatment
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* Device: Carpal Tunnel Release with Platelet-Rich Plasma
* Procedure: Carpal Tunnel Release without Platelet-Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult age 18 years and up. 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: Younger than age 18 years (minor status). Diagnosed with concomitant peripheral neuropathy. Previous CTR on the affected side. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTR with PRP<br>Carpal tunnel release with adjuvant platelet-rich plasma. | Device: Carpal Tunnel Release with Platelet-Rich Plasma<br>* CTR is performed with adjuvant PRP placed intra-operatively.<br>|
| Placebo Comparator: CTR without PRP<br>Carpal tunnel release without adjuvant platelet-rich plasma. | Procedure: Carpal Tunnel Release without Platelet-Rich Plasma<br>* CTR is performed without adjuvant PRP placed intra-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. | up to 1 month pre-op | 
| Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. | 3 months post-op | 
| Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. | 6 months post-op | 
| Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. | 12 months post-op | 
| Grip Strength | Measured with a dynamometer. | up to 1 month pre-op | 
| Grip Strength | Measured with a dynamometer. | 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome. | up to 1 month pre-op | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) | Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome. | 3 months post-op | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) | Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome. | 6 months post-op | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) | Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome. | 12 months post-op | 
| 2 Point Discrimination at Thumb | Minimal distance that the patient feels 2 separate points of touch. | up to 1 month pre-op | 
| 2 Point Discrimination at Thumb | Minimal distance that the patient feels 2 separate points of touch. | 12 months post-op | 
| 2 Point Discrimination at Index Finger | Minimal distance that the patient still feels 2 separate points of touch. | up to 1 month pre-op | 
| 2 Point Discrimination at Index Finger | Minimal distance that the patient still feels 2 separate points of touch. | 12 months post-op | 
| 2 Point Discrimination at Middle Finger | Minimal distance that the patient still feels 2 separate points of touch. | up to 1 month pre-op | 
| 2 Point Discrimination at Middle Finger | Minimal distance that the patient still feels 2 separate points of touch. | 12 months post-op | 
| Key Pinch | Measured with a pinch meter. | up to 1 month pre-op | 
| Key Pinch | Measured with a pinch meter. | 12 months post-op | 
| 3 Finger Pinch | Measured with a pinch meter. | up to 1 month pre-op | 
| 3 Finger Pinch | Measured with a pinch meter. | 12 months post-op | 
| Median Motor Latency | From EMG/NCS data. | up to 1 month pre-op | 
| Median Motor Latency | From EMG/NCS data. | 12 months post-op | 
| Median Motor Amplitude | From EMG/NCS data. | up to 1 month pre-op | 
| Median Motor Amplitude | From EMG/NCS data. | 12 months post-op | 
| Median Sensory Latency | From EMG/NCS data. | up to 1 month pre-op | 
| Median Sensory Latency | From EMG/NCS data. | 12 months post-op | 
| Median Sensory Amplitude | From EMG/NCS data. | up to 1 month pre-op | 
| Median Sensory Amplitude | From EMG/NCS data. | 12 months post-op | 
| EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity. | up to 1 month pre-op | 
| EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity. | 12 months post-op |