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

46 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 5 7}

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

References

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

Outcome predictors of platelet-rich plasma injection for moderate carpal tunnel syndrome. [2021]

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]

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]

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]

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]

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]

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]