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Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial (PRP-CTS)

C

Cardenal Herrera University

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: Platelet-rich plasma
Procedure: Platelet-poor plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT03548259
UNIVERSITY CARDENAL HERRERA-18

Details and patient eligibility

About

The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.

Design: Randomized Controlled Trial. Setting: Local Hospital.

Full description

Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.

The treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.

Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.

We propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with Carpal Tunnel Syndrome (CTS)
  • Conservative treatment failure

Exclusion criteria

  • Previous CTS surgery on the same side
  • Wrist fracture/trauma in history
  • Polyneuropathy
  • Diabetes mellitus
  • Cervical neuropathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
Description:
Platelet-rich plasma
Treatment:
Procedure: Platelet-poor plasma
Procedure: Platelet-rich plasma
Platelet-poor plasma
Placebo Comparator group
Description:
Platelet-poor plasma
Treatment:
Procedure: Platelet-poor plasma
Procedure: Platelet-rich plasma

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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