Carpal Tunnel SyndromeNCT04811287
PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
A study testing Carpal Tunnel Release with Platelet-Rich Plasma and Carpal Tunnel Release without Platelet-Rich Plasma in people with Carpal Tunnel Syndrome and PRP, run by Michael Fredericson, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, PRP
- What is being tested?
- Carpal Tunnel Release with Platelet-Rich Plasma and Carpal Tunnel Release without Platelet-Rich Plasma
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Younger than age 18 years (minor status).
- Diagnosed with concomitant peripheral neuropathy.
- Previous CTR on the affected side.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
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.
Read the detailed description
- 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.
- 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).
- 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.
- 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).
- 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.
- The investigators will store data in REDCap.
- Data will be analyzed with the assistance of our biostatistician, and results will be written up.
- Conditions
- Carpal Tunnel Syndrome, PRP
- Being tested
- Carpal Tunnel Release with Platelet-Rich Plasma, Carpal Tunnel Release without Platelet-Rich Plasma
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal Tunnel Release with Platelet-Rich PlasmaDevice
CTR is performed with adjuvant PRP placed intra-operatively.
Carpal Tunnel Release without Platelet-Rich PlasmaProcedure or surgery
CTR is performed without adjuvant PRP placed intra-operatively.
| Study group | Role | What they receive |
|---|---|---|
| CTR with PRP | Active comparator | Carpal tunnel release with adjuvant platelet-rich plasma. Receives: Device: Carpal Tunnel Release with Platelet-Rich Plasma |
| CTR without PRP | Placebo comparator | Carpal tunnel release without adjuvant platelet-rich plasma. Receives: Procedure: Carpal Tunnel Release without Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
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.
Measured: up to 1 month pre-op
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
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.
Measured: 3 months post-op
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
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.
Measured: 6 months post-op
Grip Strength
Measured with a dynamometer.
Measured: up to 1 month pre-op
Grip Strength
Measured with a dynamometer.
Measured: 6 months post-op
Secondary outcomes (23)
Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: up to 1 month pre-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: 3 months post-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: 6 months post-op
2 Point Discrimination at Thumb
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb
Measured: up to 1 month pre-op
2 Point Discrimination at Thumb
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb
Measured: 6 months post-op
2 Point Discrimination at Index Finger
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger
Measured: up to 1 month pre-op
2 Point Discrimination at Index Finger
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger
Measured: 6 months post-op
2 Point Discrimination at Middle Finger
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger
Measured: up to 1 month pre-op
2 Point Discrimination at Middle Finger
Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger
Measured: 6 months post-op
Key Pinch
Measured with a pinch meter.
Measured: up to 1 month pre-op
Key Pinch
Measured with a pinch meter.
Measured: 6 months post-op
3 Finger Pinch
Measured with a pinch meter.
Measured: up to 1 month pre-op
3 Finger Pinch
Measured with a pinch meter.
Measured: 6 months post-op
Median Motor Latency
From EMG/NCS data.
Measured: up to 1 month pre-op
Median Motor Latency
From EMG/NCS data.
Measured: 6 months post-op
Median Motor Amplitude
From EMG/NCS data.
Measured: up to 1 month pre-op
Median Motor Amplitude
From EMG/NCS data.
Measured: 6 months post-op
Median Sensory Latency
From EMG/NCS data.
Measured: up to 1 month pre-op
Median Sensory Latency
From EMG/NCS data.
Measured: 6 months post-op
Median Sensory Amplitude
From EMG/NCS data.
Measured: up to 1 month pre-op
Median Sensory Amplitude
From EMG/NCS data.
Measured: 6 months post-op
EMG of Abductor Pollicis Brevis
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
Measured: up to 1 month pre-op
EMG of Abductor Pollicis Brevis
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
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start15 Oct 2021
- Primary completion1 Mar 2025
- Study completion1 Jul 2025
Why it stopped: Accrual difficulty with low recruitment and retention in the study. The protocol was deemed not feasible; therefore, the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Fredericson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Fredericson, MD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811287
- Sponsor's protocol ID
- 59044
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2021
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32034241
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04811287
- Acronym / sponsor ID
- 59044
- Conditions
- Carpal Tunnel Syndrome, PRP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual difficulty with low recruitment and retention in the study. The protocol was deemed not feasible; therefore, the study was terminated.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Michael Fredericson, MDUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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).
- 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.
- 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).
- 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.
- The investigators will store data in REDCap.
- Data will be analyzed with the assistance of our biostatistician, and results will be written up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CTR with PRP | Active comparator | Device: Carpal Tunnel Release with Platelet-Rich PlasmaCarpal tunnel release with adjuvant platelet-rich plasma. |
| CTR without PRP | Placebo comparator | Procedure: Carpal Tunnel Release without Platelet-Rich PlasmaCarpal tunnel release without adjuvant platelet-rich plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Younger than age 18 years (minor status).
- Diagnosed with concomitant peripheral neuropathy.
- Previous CTR on the affected side.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carpal Tunnel Release with Platelet-Rich PlasmaCTR is performed with adjuvant PRP placed intra-operatively. | Device | CTR with PRP |
| Carpal Tunnel Release without Platelet-Rich PlasmaCTR is performed without adjuvant PRP placed intra-operatively. | Procedure or surgery | CTR without PRP |
Primary outcome
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Time frame: 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.
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Time frame: 3 months 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.
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire
Time frame: 6 months 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.
Grip Strength
Time frame: up to 1 month pre-op
Measured with a dynamometer.
Grip Strength
Time frame: 6 months post-op
Measured with a dynamometer.
23 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: up to 1 month pre-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 3 months post-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6 months post-op
2 Point Discrimination at Thumb
Time frame: up to 1 month pre-op
2 Point Discrimination at Thumb
Time frame: 6 months post-op
2 Point Discrimination at Index Finger
Time frame: up to 1 month pre-op
2 Point Discrimination at Index Finger
Time frame: 6 months post-op
2 Point Discrimination at Middle Finger
Time frame: up to 1 month pre-op
2 Point Discrimination at Middle Finger
Time frame: 6 months post-op
Key Pinch
Time frame: up to 1 month pre-op
Key Pinch
Time frame: 6 months post-op
3 Finger Pinch
Time frame: up to 1 month pre-op
3 Finger Pinch
Time frame: 6 months post-op
Median Motor Latency
Time frame: up to 1 month pre-op
Median Motor Latency
Time frame: 6 months post-op
Median Motor Amplitude
Time frame: up to 1 month pre-op
Median Motor Amplitude
Time frame: 6 months post-op
Median Sensory Latency
Time frame: up to 1 month pre-op
Median Sensory Latency
Time frame: 6 months post-op
Median Sensory Amplitude
Time frame: up to 1 month pre-op
Median Sensory Amplitude
Time frame: 6 months post-op
EMG of Abductor Pollicis Brevis
Time frame: up to 1 month pre-op
EMG of Abductor Pollicis Brevis
Time frame: 6 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32034241Trull-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal Tunnel Release with Platelet-Rich Plasma and Carpal Tunnel Release without Platelet-Rich Plasma in people with Carpal Tunnel Syndrome and PRP, run by Michael Fredericson, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire (time frame: up to 1 month pre-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.