Carpal Tunnel Syndrome, PRP
Conditions
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.
Interventions
DEVICECarpal Tunnel Release with Platelet-Rich Plasma
CTR is performed with adjuvant PRP placed intra-operatively.
PROCEDURECarpal Tunnel Release without Platelet-Rich Plasma
CTR is performed without adjuvant PRP placed intra-operatively.
Sponsors
Michael Fredericson, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
See Model Description above.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | up to 1 month pre-op | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. |
| Grip Strength | up to 1 month pre-op | Measured with a dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) | up to 1 month pre-op | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. |
| 2 Point Discrimination at Thumb | up to 1 month pre-op | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb |
| 2 Point Discrimination at Index Finger | up to 1 month pre-op | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger |
| 2 Point Discrimination at Middle Finger | up to 1 month pre-op | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger |
| Key Pinch | up to 1 month pre-op | Measured with a pinch meter. |
| 3 Finger Pinch | up to 1 month pre-op | Measured with a pinch meter. |
| Median Motor Latency | up to 1 month pre-op | From EMG/NCS data. |
| Median Motor Amplitude | up to 1 month pre-op | From EMG/NCS data. |
| Median Sensory Latency | up to 1 month pre-op | From EMG/NCS data. |
| Median Sensory Amplitude | up to 1 month pre-op | From EMG/NCS data. |
| EMG of Abductor Pollicis Brevis | up to 1 month pre-op | From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 11 |
| other Total, other adverse events | 0 / 4 | 0 / 11 |
| serious Total, serious adverse events | 0 / 4 | 0 / 11 |
Outcome results
None listed