Platelet-Rich Plasma for Carpal Tunnel Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Michael Fredericson, MD

Must not be taking: NSAIDs, Steroids

Disqualifiers: Peripheral neuropathy, Previous CTR, others

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used NSAIDs (like ibuprofen) within 48 hours of the procedure or systemic steroids within 2 weeks.

What data supports the effectiveness of this treatment for carpal tunnel syndrome?

Research shows that using platelet-rich plasma (PRP) as an additional treatment after carpal tunnel surgery helps patients regain their hand grip strength faster compared to those who did not receive PRP. This suggests that PRP can be an effective addition to surgery for improving recovery in carpal tunnel syndrome.

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Is platelet-rich plasma therapy safe for humans?

Research indicates that platelet-rich plasma (PRP) therapy is generally safe for humans, as studies have not reported significant safety concerns or complications related to its use in treating carpal tunnel syndrome.

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How does the treatment with Platelet-Rich Plasma for Carpal Tunnel Syndrome differ from other treatments?

The treatment with Platelet-Rich Plasma (PRP) for Carpal Tunnel Syndrome is unique because it uses the patient's own blood components to promote healing and improve hand grip strength after surgery, unlike standard treatments that may not enhance recovery in the same way.

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Eligibility Criteria

This trial is for adults over 18 with severe Carpal Tunnel Syndrome (CTS) confirmed by EMG/NCS tests. It's not for those who have platelet disorders, recent steroid or NSAID use, infections, tobacco use, fever/illness recently, cancer, other nerve issues or previous CTR surgery on the same hand.

Inclusion Criteria

I have severe carpal tunnel syndrome confirmed by nerve tests.

I am 18 years old or older.

Exclusion Criteria

I do not have conditions that would make PRP unsafe for me.

I have been diagnosed with nerve damage in my hands or feet.

I have had chest radiation therapy on the affected side before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Participants undergo pre-operative electromyography/nerve conduction study (EMG/NCS) and complete initial outcome measures

1 month

1 visit (in-person)

Treatment

Participants undergo carpal tunnel release (CTR) with or without adjuvant platelet-rich plasma (PRP)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with outcome measures collected at 3 and 6 months post-operatively

6 months

2 visits (in-person), online assessments

Participant Groups

The study compares two groups: one receiving Carpal Tunnel Release (CTR) surgery with Platelet-Rich Plasma (PRP), and another undergoing just CTR without PRP. The goal is to see if adding PRP improves outcomes in patients with severe CTS after the common CTR procedure.

Group I: CTR with PRP Active Control 1 Intervention

Carpal tunnel release with adjuvant platelet-rich plasma.

Group II: CTR without PRP Placebo Group 1 Intervention

Carpal tunnel release without adjuvant platelet-rich plasma.

Carpal Tunnel Release without Platelet-Rich Plasma is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as Carpal Tunnel Release for:

• Carpal tunnel syndrome

🇪🇺 Approved in European Union as Carpal Tunnel Release for:

• Carpal tunnel syndrome

🇨🇦 Approved in Canada as Carpal Tunnel Release for:

• Carpal tunnel syndrome

🇯🇵 Approved in Japan as Carpal Tunnel Release for:

• Carpal tunnel syndrome

🇨🇳 Approved in China as Carpal Tunnel Release for:

• Carpal tunnel syndrome

🇨🇭 Approved in Switzerland as Carpal Tunnel Release for:

• Carpal tunnel syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Redwood City, CA

Who Is Running the Clinical Trial?

Michael Fredericson, MD Lead Sponsor

Factor Medical Collaborator

References

1. India pubmed.ncbi.nlm.nih.gov

Outcome predictors of platelet-rich plasma injection for moderate carpal tunnel syndrome. [2021] Platelet-rich plasma (PRP) injection is effective for mild-to-moderate carpal tunnel syndrome (CTS), and physicians have been using PRP injections to treat CTS. However, the predictive factors of PRP injections have not been evaluated. This retrospective study sought to identify the predictive factors of PRP injections in patients with moderate CTS.

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma as an adjuvant to surgical carpal ligament release: a prospective, randomized controlled clinical trial. [2021] The purpose of this study is to evaluate the efficiency of local platelet-rich plasma (PRP) injection as an adjuvant treatment after carpal ligament release. We conducted a prospective randomized, triple-blinded, controlled trial. Fifty participants with mild to extreme carpal tunnel syndrome (CTS) were randomly assigned either to the PRP (n = 25) or the platelet-poor plasma (PPP, n = 25) group. After performing open surgical release of the carpal ligament, the inside of the carpal tunnel was irrigated with 3 mL of PRP or PPP according to each participant's group allocation. The primary outcome was hand grip strength (HGS). Secondary outcomes were the time taken off work after surgery (in days) and scores on the Wong-Baker Faces Scale, Boston Carpal Tunnel Questionnaire, and Southampton Wound Assessment Scale. We evaluated patients before treatment and at 6-weeks. As expected, the pain levels, symptom severity, and functional status improved in all the patients after surgery. However, intragroup analysis revealed that only the participants in the PRP group had regained their pre-operative HGS levels at 6-weeks follow-up. These findings indicate that PRP is an effective adjuvant treatment in patients with mild to severe CTS who require surgery.

3. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Platelet-Rich Plasma and Radial Extracorporeal Shock Wave Compared with Platelet-Rich Plasma in the Treatment of Moderate Carpal Tunnel Syndrome. [2022] To evaluate the combination effect of platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) for moderate carpal tunnel syndrome (CTS), compared with PRP alone.

4. United States pubmed.ncbi.nlm.nih.gov

The Risk of Complications after Carpal Tunnel Release in Patients Taking Acetylsalicylic Acid as Platelet Inhibition: A Multicenter Propensity Score-Matched Study. [2021] Carpal tunnel release is one of the most common procedures in hand surgery. There is only scarce evidence regarding whether platelet inhibitors increase the risk of developing postoperative hemorrhage in carpal tunnel release.

5. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Corticosteroid Injections for the Treatment of Mild-to-Moderate Carpal Tunnel Syndrome: A Markov Cost-Effectiveness Decision Analysis. [2022] Platelet-rich plasma (PRP) or corticosteroid injections may be used to conservatively treat mild-to-moderate carpal tunnel syndrome (CTS). We evaluated the cost-effectiveness of PRP injections versus corticosteroid injections for the treatment of mild-to-moderate CTS.

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma Injections for Nonsurgical Management of Carpal Tunnel Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2020] To systematically review and evaluate the efficacy and complication profile of platelet-rich plasma (PRP) injection into the carpal tunnel for management of carpal tunnel syndrome (CTS).

7. United States pubmed.ncbi.nlm.nih.gov

One-Year Efficacy of Platelet-Rich Plasma for Moderate-to-Severe Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. [2021] To assess the therapeutic effect of platelet-rich plasma (PRP) for moderate-to-severe carpal tunnel syndrome (CTS).