Trial Outcomes & Findings for PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome (NCT NCT04811287)
NCT ID: NCT04811287
Last Updated: 2026-04-30
Results Overview
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.
TERMINATED
NA
15 participants
6 months post-op
2026-04-30
Participant Flow
Participant milestones
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
Baseline characteristics by cohort
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
12 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
6 Participants
n=34 Participants
|
10 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
12 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
9 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=14 Participants
|
11 Participants
n=34 Participants
|
15 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: up to 1 month pre-opPatient-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.
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Symptom Severity Scale - Severe
|
1 Participants
|
3 Participants
|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Symptom Severity Scale - Very Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Functional Status Scale - Severe
|
0 Participants
|
3 Participants
|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Functional Status Scale - Very Severe
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months post-opPopulation: Participants with available data for the Boston Carpal Tunnel Questionnaire 3-month post-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.
Outcome measures
| Measure |
CTR With PRP
n=2 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=7 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Symptom Severity Scale
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Functional Status Scale
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for the Boston Carpal Tunnel Questionnaire 6-month post-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.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Symptom Severity Scale
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Functional Status Scale
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for the grip strength 1-month pre-op
Measured with a dynamometer.
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=10 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Grip Strength
|
11.40 kg
Standard Deviation 3.89
|
19.14 kg
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for Grip Strength 6-month post-op
Measured with a dynamometer.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=4 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Grip Strength
|
—
|
18.85 kg
Standard Deviation 7.71
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for the PROMIS Questionnaire 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.
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=10 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
|
36.73 T-Score
Standard Deviation 9.18
|
34.41 T-Score
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: 3 months post-opPopulation: Participants with available data for the PROMIS Questionnaire 3-months post-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.
Outcome measures
| Measure |
CTR With PRP
n=2 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=7 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
|
36.8 T-Score
Standard Deviation 18.4
|
39.11 T-Score
Standard Deviation 5.59
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for the PROMIS Questionnaire 6-months post-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.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=4 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
|
29.50 T-Scores
|
44.68 T-Scores
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: up to 1 month pre-opCount of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Thumb
Able to discriminate between the 2 points
|
2 Participants
|
5 Participants
|
|
2 Point Discrimination at Thumb
Not able to discriminate between the 2 points
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for 2-point discrimination at the thumb 6-month post-op
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Thumb
Able to discriminate between the 2 points
|
—
|
2 Participants
|
|
2 Point Discrimination at Thumb
Not able to discriminate between the 2 points
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 1 month pre-opCount of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Index Finger
Able to discriminate between the 2 points
|
2 Participants
|
7 Participants
|
|
2 Point Discrimination at Index Finger
Not able to discriminate between the 2 points
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for 2 point discrimination at thuumb 6-month post-op
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Index Finger
Able to discriminate between the 2 points
|
—
|
2 Participants
|
|
2 Point Discrimination at Index Finger
Not able to discriminate between the 2 points
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 1 month pre-opCount of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Middle Finger
Able to discriminate between the 2 points
|
1 Participants
|
7 Participants
|
|
2 Point Discrimination at Middle Finger
Not able to discriminate between the 2 points
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for 2 point discrimination at thumb 6 month post op
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
2 Point Discrimination at Middle Finger
Able to discriminate between the 2 points
|
—
|
3 Participants
|
|
2 Point Discrimination at Middle Finger
Not able to discriminate between the 2 points
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 1 month pre-opMeasured with a pinch meter.
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Key Pinch
|
2.93 kg
Standard Deviation 0.73
|
4.36 kg
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for Key Pinch 6-month post-op
Measured with a pinch meter.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Key Pinch
|
—
|
5.67 kg
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: up to 1 month pre-opMeasured with a pinch meter.
Outcome measures
| Measure |
CTR With PRP
n=4 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=11 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
3 Finger Pinch
|
2.28 kg
Standard Deviation 0.57
|
4.03 kg
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for 3 finger pinch 6-month post-op
Measured with a pinch meter.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
3 Finger Pinch
|
—
|
4.43 kg
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for median motor latency 1 month pre op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=6 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Motor Latency
|
4.8 ms
|
6.16 ms
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for median motor latency 6 months post op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Motor Latency
|
—
|
3.28 ms
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for median motor amplitude 1 month pre op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=6 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Motor Amplitude
|
1.9 mV
|
4.35 mV
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for median motor amplitude 6 month post op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Motor Amplitude
|
—
|
1.2 mV
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for median sensory latency 1 month pre op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=6 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Sensory Latency
|
4.3 ms
|
4.6 ms
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for median sensory latency 6 month post op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Sensory Latency
|
—
|
3.08 ms
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for median sensory amplitude 1 month pre op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=6 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Sensory Amplitude
|
5 mV
|
9.63 mV
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for median sensory amplitude 6 month post op
From EMG/NCS data.
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
Median Sensory Amplitude
|
—
|
7.07 mV
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: up to 1 month pre-opPopulation: Participants with available data for EMG of Abductor Pollicis Brevis 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
Outcome measures
| Measure |
CTR With PRP
n=1 Participants
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=5 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
EMG of Abductor Pollicis Brevis
Signs of Denervation
|
0 Participants
|
2 Participants
|
|
EMG of Abductor Pollicis Brevis
Signs of Reinnervation
|
0 Participants
|
0 Participants
|
|
EMG of Abductor Pollicis Brevis
No Spontaneous Activity
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months post-opPopulation: Participants with available data for EMG of Abductor Pollicis Brevis 6 month post 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
Outcome measures
| Measure |
CTR With PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR Without PRP
n=3 Participants
Carpal tunnel release without adjuvant platelet-rich plasma.
|
|---|---|---|
|
EMG of Abductor Pollicis Brevis
Signs of Denervation
|
—
|
0 Participants
|
|
EMG of Abductor Pollicis Brevis
Signs of Reinnervation
|
—
|
0 Participants
|
|
EMG of Abductor Pollicis Brevis
No Spontaneous Activity
|
—
|
3 Participants
|
Adverse Events
CTR With PRP
CTR Without PRP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place