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

NCT ID: NCT03548259

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2018-11-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial (Parallel Assignment)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind

Study Groups

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Experimental

Platelet-rich plasma

Group Type EXPERIMENTAL

Platelet-rich plasma

Intervention Type PROCEDURE

Platelet-rich plasma injection

Platelet-poor plasma

Intervention Type PROCEDURE

Platelet-poor plasma injection

Platelet-poor plasma

Platelet-poor plasma

Group Type PLACEBO_COMPARATOR

Platelet-rich plasma

Intervention Type PROCEDURE

Platelet-rich plasma injection

Platelet-poor plasma

Intervention Type PROCEDURE

Platelet-poor plasma injection

Interventions

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Platelet-rich plasma

Platelet-rich plasma injection

Intervention Type PROCEDURE

Platelet-poor plasma

Platelet-poor plasma injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Juan F. Lisón Párraga, Dr

Head of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignacio Pérez, PhD

Role: STUDY_CHAIR

Cardenal Herrera University

Locations

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Universidad CEU Cardenal Herrera

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UNIVERSITY CARDENAL HERRERA-18

Identifier Type: -

Identifier Source: org_study_id

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