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Platelet-Rich Plasma for Carpal Tunnel Syndrome

N/A
Recruiting
Research Sponsored by Michael Fredericson, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Be older than 18 years old
Must not have
Diagnosed with concomitant peripheral neuropathy.
Previous CTR on the affected side.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-op

Summary

This trial is studying if adding platelet-rich plasma to carpal tunnel release surgery can help improve outcomes for patients with severe carpal tunnel syndrome.

Who is the study for?
This trial is for adults over 18 with severe Carpal Tunnel Syndrome (CTS) confirmed by EMG/NCS tests. It's not for those who have platelet disorders, recent steroid or NSAID use, infections, tobacco use, fever/illness recently, cancer, other nerve issues or previous CTR surgery on the same hand.
What is being tested?
The study compares two groups: one receiving Carpal Tunnel Release (CTR) surgery with Platelet-Rich Plasma (PRP), and another undergoing just CTR without PRP. The goal is to see if adding PRP improves outcomes in patients with severe CTS after the common CTR procedure.
What are the potential side effects?
Potential side effects may include discomfort at injection site from PRP treatment, bleeding or bruising due to needle insertion during PRP preparation and administration. There might also be risks associated with any surgical intervention like infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe carpal tunnel syndrome confirmed by nerve tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with nerve damage in my hands or feet.
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I have had chest radiation therapy on the affected side before.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Boston Carpal Tunnel Questionnaire
Grip Strength
Secondary study objectives
2 Point Discrimination at Index Finger
2 Point Discrimination at Middle Finger
2 Point Discrimination at Thumb
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CTR with PRPActive Control1 Intervention
Carpal tunnel release with adjuvant platelet-rich plasma.
Group II: CTR without PRPPlacebo Group1 Intervention
Carpal tunnel release without adjuvant platelet-rich plasma.

Find a Location

Who is running the clinical trial?

Michael Fredericson, MDLead Sponsor
Factor MedicalUNKNOWN
~2 spots leftby Feb 2025
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