PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Not Applicable

Active, not recruiting

• Conditions: Carpal Tunnel Syndrome; PRP
• Interventions: Device: Carpal Tunnel Release with Platelet-Rich Plasma; Procedure: Carpal Tunnel Release without Platelet-Rich Plasma

• Registration Number: NCT04811287
• Lead Sponsor: Michael Fredericson, MD

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-10-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-21
• Primary Completion: 2026-08-28
• Study Completion: 2026-12-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTR with PRP	Carpal Tunnel Release with Platelet-Rich Plasma	Carpal tunnel release with adjuvant platelet-rich plasma.
CTR without PRP	Carpal Tunnel Release without Platelet-Rich Plasma	Carpal tunnel release without adjuvant platelet-rich plasma.

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire	6 months post-op	Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
Grip Strength	6 months post-op	Measured with a dynamometer.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States