Platelet-Rich Plasma for Carpal Tunnel Syndrome

Overseen By Anne Kuwabara, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Fredericson, MD

Must not be taking: NSAIDs, Steroids

Disqualifiers: Peripheral neuropathy, Previous CTR, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding platelet-rich plasma (PRP) to surgery can improve outcomes for people with severe carpal tunnel syndrome (CTS). Carpal tunnel syndrome causes pain and numbness in the hand and wrist. The trial compares outcomes for those undergoing only Carpal Tunnel Release surgery and those receiving the surgery with PRP. It seeks participants with severe CTS symptoms that have not improved with other treatments. As an unphased trial, this study provides patients the chance to explore innovative treatment options that may enhance recovery outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that platelet-rich plasma (PRP) is generally safe for treating carpal tunnel syndrome (CTS). Studies have found that using PRP with carpal tunnel release surgery (CTR) can improve health outcomes for patients with moderate CTS. Importantly, these studies also found no major side effects from PRP treatments.

Several clinical trials reported PRP to be both effective and safe for patients, with no serious negative effects linked to its use. This suggests that PRP is well-tolerated when added to surgeries like CTR.

Overall, while PRP appears promising in improving surgery results, the safety data reassures those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using platelet-rich plasma (PRP) in carpal tunnel release surgery because it introduces a new approach to healing. Unlike standard treatments like corticosteroid injections or surgery alone, PRP involves using a concentration of your own platelets, which are rich in growth factors. These growth factors can potentially speed up recovery and enhance tissue repair compared to traditional methods. This innovative use of PRP could make recovery smoother and quicker for people suffering from carpal tunnel syndrome.

What evidence suggests that this trial's treatments could be effective for severe carpal tunnel syndrome?

This trial will compare Carpal Tunnel Release (CTR) with and without Platelet-Rich Plasma (PRP) for treating Carpal Tunnel Syndrome (CTS). Research has shown that using PRP with CTR surgery can enhance recovery for people with CTS. One study found that PRP with CTR improved hand function and reduced symptoms in patients with moderate CTS. Another study demonstrated that PRP injections were more effective than other treatments in reducing pain and improving wrist movement. PRP also led to significant improvements on a questionnaire measuring symptom severity and hand function. These findings suggest PRP could enhance recovery after surgery for severe CTS. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Carpal Tunnel Release without Platelet-Rich Plasma
• Carpal Tunnel Release with Platelet-Rich Plasma

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Michael Fredericson, MD

Lead Sponsor

Trials

1

Recruited

50+

Factor Medical

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 635 carpal tunnel release procedures, it was found that taking acetylsalicylic acid (a platelet inhibitor) did not significantly increase the risk of postoperative bleeding complications, indicating that surgery can be safely performed without stopping this medication.

Despite some patients experiencing bleeding complications, overall patient satisfaction remained high (median score of 10 out of 10), and functional outcomes were not significantly different between those on acetylsalicylic acid and those not, suggesting that the medication does not adversely affect recovery.

NCBI (Pubmed)

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. Kaltenborn, A., Frey-Wille, S., Hoffmann, S., et al.[2021]

In a study of 50 participants with carpal tunnel syndrome, those receiving platelet-rich plasma (PRP) injections after surgery showed significant improvement in hand grip strength compared to those receiving platelet-poor plasma (PPP).

The results suggest that PRP is an effective adjuvant treatment for enhancing recovery in patients undergoing carpal ligament release surgery, as only the PRP group regained their pre-operative hand grip strength by the 6-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma as an adjuvant to surgical carpal ligament release: a prospective, randomized controlled clinical trial. Trull-Ahuir, C., Sala, D., Chismol-Abad, J., et al.[2021]

In a study of 71 patients with moderate carpal tunnel syndrome (CTS) receiving platelet-rich plasma (PRP) injections, lower baseline body weight, distal motor latency, and cross-sectional area of the median nerve were associated with better outcomes at 3 and 6 months post-injection.

The study identified specific predictive factors for the efficacy of PRP injections, suggesting that patients with these characteristics may experience greater relief from CTS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome predictors of platelet-rich plasma injection for moderate carpal tunnel syndrome. Shen, YP., Li, TY., Chou, YC., et al.[2021]

In a study involving 40 patients with moderate carpal tunnel syndrome, the combination of platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) did not show significant overall benefits compared to PRP alone, except for some improvements in symptoms at one month and motor latency at three months.

The results suggest that while PRP combined with a single session of ESWT may provide some short-term benefits, further research with multiple ESWT sessions and longer follow-up is necessary to fully assess the effectiveness of this treatment approach.

NCBI (Pubmed)

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. Chang, CY., Chen, LC., Chou, YC., et al.[2022]

Platelet-rich plasma (PRP) injections significantly improve symptoms of carpal tunnel syndrome (CTS) compared to control treatments, with a notable reduction in the Boston Carpal Tunnel Questionnaire scores, indicating better patient outcomes.

The complication rate from PRP injections is low, with only 4 out of 97 participants experiencing mild, transient side effects, suggesting that PRP is a safe option for managing mild to moderate CTS.

NCBI (Pubmed)

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. Catapano, M., Catapano, J., Borschel, G., et al.[2020]

Platelet-rich plasma (PRP) injections are more cost-effective than corticosteroid injections for treating mild-to-moderate carpal tunnel syndrome (CTS), based on a Markov modeling analysis of a hypothetical 45-year-old patient.

The analysis showed that PRP injections provided greater net monetary benefits and lower incremental cost-effectiveness ratios compared to corticosteroids, indicating that PRP is a better option from both healthcare and societal perspectives.

NCBI (Pubmed)

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. Klifto, KM., Klifto, CS., Pidgeon, TS., et al.[2022]

In a study involving 26 patients with moderate-to-severe carpal tunnel syndrome, a single ultrasound-guided injection of platelet-rich plasma (PRP) significantly improved symptoms and function compared to a control group receiving saline, with benefits lasting up to one year.

The PRP group showed notable improvements in both severity and functional scores on the Boston Carpal Tunnel Syndrome Questionnaire, as well as a reduction in the median nerve's cross-sectional area, indicating effective therapeutic action.

NCBI (Pubmed)

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. Chen, SR., Shen, YP., Ho, TY., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9382812/

platelet-rich plasma combined with carpal tunnel release ... In this study, CTR combined with PRP treatment has been reported to improve the health outcomes and functions of patients with moderate symptoms ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092282/

Effectiveness of Platelet-Rich Plasma for Patients With ... Local PRP injection is more effective than other conservative treatments in terms of mid-term efficacy in relieving pain, improving wrist function and symptoms.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999319314364

Effectiveness of Platelet-Rich Plasma Injections for ... PRP results in significant improvement in the Boston Carpal Tunnel Questionnaire but no change in the visual analog scale. •. PRP represents a promising ...

4. nature.com nature.com/articles/s41598-020-59113-0

Efficacy of platelet-rich plasma as an adjuvant to surgical ... 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03184688

Platelet Rich Plasma for Carpal Tunnel Syndrome The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9684083/

Efficacy and safety of platelet-rich plasma in the treatment ... A series of clinical trials in recent years had shown that PRP infusion could achieve significant benefits and safe results in patients with CTS ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25001778

A systematic review of the clinical application of platelet ... PRP shows promise in the non-surgical management of carpal tunnel syndrome, ulnar neuritis, common peroneal nerve palsy, and piriformis syndrome.