PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

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

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.

Study Overview

• Status: Terminated
• Conditions: Carpal Tunnel Syndrome; PRP
• Intervention / Treatment: Device: Carpal Tunnel Release with Platelet-Rich Plasma; Procedure: Carpal Tunnel Release without Platelet-Rich Plasma

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Measured with a dynamometer.	up to 1 month pre-op
Grip Strength	Measured with a dynamometer.	6 months post-op
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.	up to 1 month pre-op
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.	3 months post-op
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.	6 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Pinch	Measured with a pinch meter.	up to 1 month pre-op
3 Finger Pinch	Measured with a pinch meter.	up to 1 month pre-op
Median Motor Latency	From EMG/NCS data.	up to 1 month pre-op
Median Motor Amplitude	From EMG/NCS data.	up to 1 month pre-op
Median Sensory Latency	From EMG/NCS data.	up to 1 month pre-op
Median Sensory Amplitude	From EMG/NCS data.	up to 1 month pre-op
Key Pinch	Measured with a pinch meter.	6 months post-op
3 Finger Pinch	Measured with a pinch meter.	6 months post-op
Median Motor Latency	From EMG/NCS data.	6 months post-op
Median Motor Amplitude	From EMG/NCS data.	6 months post-op
Median Sensory Latency	From EMG/NCS data.	6 months post-op
Median Sensory Amplitude	From EMG/NCS data.	6 months post-op
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.	up to 1 month pre-op
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.	3 months post-op
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.	6 months post-op
2 Point Discrimination at Thumb	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb	up to 1 month pre-op
2 Point Discrimination at Thumb	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb	6 months post-op
2 Point Discrimination at Index Finger	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger	up to 1 month pre-op
2 Point Discrimination at Index Finger	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger	6 months post-op
2 Point Discrimination at Middle Finger	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger	up to 1 month pre-op
2 Point Discrimination at Middle Finger	Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger	6 months post-op
EMG of Abductor Pollicis Brevis	From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves	up to 1 month pre-op
EMG of Abductor Pollicis Brevis	From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves	6 months post-op

Collaborators and Investigators

• Sponsor: Michael Fredericson, MD
• Collaborators: Factor Medical

Publications and helpful links

General Publications

• Trull-Ahuir C, Sala D, Chismol-Abad J, Vila-Caballer M, Lison JF. Efficacy of platelet-rich plasma as an adjuvant to surgical carpal ligament release: a prospective, randomized controlled clinical trial. Sci Rep. 2020 Feb 7;10(1):2085. doi: 10.1038/s41598-020-59113-0.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 59044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes