TerminatedNot Applicable

PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Stopped: Accrual difficulty with low recruitment and retention in the study. The protocol was deemed not feasible; therefore, the study was terminated.

United States15 participantsStarted 2021-10-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 1 month pre-op

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

Timeframe: 3 months post-op

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

Timeframe: 6 months post-op

Grip Strength

Timeframe: up to 1 month pre-op

Grip Strength

Timeframe: 6 months post-op

Trial details

NCT IDNCT04811287

SponsorMichael Fredericson, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Results submitted2026-03-07

View on ClinicalTrials.gov More Carpal Tunnel Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

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

Timeframe: up to 1 month pre-op

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

Timeframe: 3 months post-op

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

Timeframe: 6 months post-op

Grip Strength

Timeframe: up to 1 month pre-op

Grip Strength

Timeframe: 6 months post-op