Treatment for Syndrome

Phase-Based Estimates
1
Effectiveness
1
Safety
Stanford University, Redwood City, CA
+2 More
Eligibility
18+
All Sexes
Eligible conditions
Syndrome

Study Summary

PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

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Eligible Conditions

  • Syndrome
  • Carpal Tunnel Syndrome
  • PRP

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 11 secondary outcomes in patients with Syndrome. Measurement will happen over the course of 12 months post-op.

12 months post-op
2 Point Discrimination at Index Finger
2 Point Discrimination at Middle Finger
2 Point Discrimination at Thumb
3 Finger Pinch
Boston Carpal Tunnel Questionnaire
EMG of Abductor Pollicis Brevis
Grip Strength
Key Pinch
Median Motor Amplitude
Median Motor Latency
Median Sensory Amplitude
Median Sensory Latency
Patient-Reported Outcomes Measurement Information System (PROMIS)

Trial Safety

Trial Design

2 Treatment Groups

CTR without PRP
Placebo group

This trial requires 46 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

CTR without PRP
Procedure
Carpal tunnel release without adjuvant platelet-rich plasma.
CTR with PRP
Device
Carpal tunnel release with adjuvant platelet-rich plasma.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post-op
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months post-op for reporting.

Closest Location

Stanford University - Redwood City, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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).

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Syndrome by sharing your contact details with the study coordinator.