Clinical trial NCT04811287: PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
Official title: Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
PRP
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: up to 1 month pre-op
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 3 months post-op
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 6 months post-op
measure: Grip Strength
timeFrame: up to 1 month pre-op
measure: Grip Strength
timeFrame: 6 months post-op
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: up to 1 month pre-op
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 3 months post-op
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6 months post-op
measure: 2 Point Discrimination at Thumb
timeFrame: up to 1 month pre-op
measure: 2 Point Discrimination at Thumb
timeFrame: 6 months post-op
measure: 2 Point Discrimination at Index Finger
timeFrame: up to 1 month pre-op
measure: 2 Point Discrimination at Index Finger
timeFrame: 6 months post-op
measure: 2 Point Discrimination at Middle Finger
timeFrame: up to 1 month pre-op
measure: 2 Point Discrimination at Middle Finger
timeFrame: 6 months post-op
measure: Key Pinch
timeFrame: up to 1 month pre-op
measure: Key Pinch
timeFrame: 6 months post-op
measure: 3 Finger Pinch
timeFrame: up to 1 month pre-op
measure: 3 Finger Pinch
timeFrame: 6 months post-op
measure: Median Motor Latency
timeFrame: up to 1 month pre-op
measure: Median Motor Latency
timeFrame: 6 months post-op
measure: Median Motor Amplitude
timeFrame: up to 1 month pre-op
measure: Median Motor Amplitude
timeFrame: 6 months post-op
measure: Median Sensory Latency
timeFrame: up to 1 month pre-op
measure: Median Sensory Latency
timeFrame: 6 months post-op
measure: Median Sensory Amplitude
timeFrame: up to 1 month pre-op
measure: Median Sensory Amplitude
timeFrame: 6 months post-op
measure: EMG of Abductor Pollicis Brevis
timeFrame: up to 1 month pre-op
measure: EMG of Abductor Pollicis Brevis
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: 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.