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 range18 Years

SexALL

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

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 range18 Years

SexALL

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