PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811287
• Other study ID #: 59044
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: Stanford University
• Contact: Donald Kasitinon, MD
• Phone: 469-371-7124
• Email: donald.kasitinon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 6 months, and 12 months post-operatively. EMG/NCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic. At these visits, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• PRP
• Syndrome

Intervention

Device:
• Carpal Tunnel Release with Platelet-Rich Plasma
CTR is performed with adjuvant PRP placed intra-operatively.

Procedure:
• Carpal Tunnel Release without Platelet-Rich Plasma
CTR is performed without adjuvant PRP placed intra-operatively.

Locations

Country	Name	City	State
United States	Stanford University	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Michael Fredericson, MD	Factor Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Trull-Ahuir C, Sala D, Chismol-Abad J, Vila-Caballer M, Lisón 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Questionnaire	Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.	up to 1 month pre-op
Primary	Boston Carpal Tunnel Questionnaire	Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.	3 months post-op
Primary	Boston Carpal Tunnel Questionnaire	Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.	6 months post-op
Primary	Boston Carpal Tunnel Questionnaire	Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.	12 months post-op
Primary	Grip Strength	Measured with a dynamometer.	up to 1 month pre-op
Primary	Grip Strength	Measured with a dynamometer.	12 months post-op
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.	up to 1 month pre-op
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.	3 months post-op
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.	6 months post-op
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)	Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.	12 months post-op
Secondary	2 Point Discrimination at Thumb	Minimal distance that the patient feels 2 separate points of touch.	up to 1 month pre-op
Secondary	2 Point Discrimination at Thumb	Minimal distance that the patient feels 2 separate points of touch.	12 months post-op
Secondary	2 Point Discrimination at Index Finger	Minimal distance that the patient still feels 2 separate points of touch.	up to 1 month pre-op
Secondary	2 Point Discrimination at Index Finger	Minimal distance that the patient still feels 2 separate points of touch.	12 months post-op
Secondary	2 Point Discrimination at Middle Finger	Minimal distance that the patient still feels 2 separate points of touch.	up to 1 month pre-op
Secondary	2 Point Discrimination at Middle Finger	Minimal distance that the patient still feels 2 separate points of touch.	12 months post-op
Secondary	Key Pinch	Measured with a pinch meter.	up to 1 month pre-op
Secondary	Key Pinch	Measured with a pinch meter.	12 months post-op
Secondary	3 Finger Pinch	Measured with a pinch meter.	up to 1 month pre-op
Secondary	3 Finger Pinch	Measured with a pinch meter.	12 months post-op
Secondary	Median Motor Latency	From EMG/NCS data.	up to 1 month pre-op
Secondary	Median Motor Latency	From EMG/NCS data.	12 months post-op
Secondary	Median Motor Amplitude	From EMG/NCS data.	up to 1 month pre-op
Secondary	Median Motor Amplitude	From EMG/NCS data.	12 months post-op
Secondary	Median Sensory Latency	From EMG/NCS data.	up to 1 month pre-op
Secondary	Median Sensory Latency	From EMG/NCS data.	12 months post-op
Secondary	Median Sensory Amplitude	From EMG/NCS data.	up to 1 month pre-op
Secondary	Median Sensory Amplitude	From EMG/NCS data.	12 months post-op
Secondary	EMG of Abductor Pollicis Brevis	From EMG/NCS data - looking at spontaneous activity.	up to 1 month pre-op
Secondary	EMG of Abductor Pollicis Brevis	From EMG/NCS data - looking at spontaneous activity.	12 months post-op