NCT03548259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

May 24, 2018

Last Update Submit

February 1, 2019

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromePlatelet-rich plasmaSurgery

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    Hand grip strength measured with dynamometer

    6 weeks

Secondary Outcomes (4)

  • Pain

    6 weeks

  • Sympton severity

    6 weeks

  • Functional status

    6 weeks

  • Wound healing

    6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Platelet-rich plasma

Procedure: Platelet-rich plasmaProcedure: Platelet-poor plasma

Platelet-poor plasma

PLACEBO COMPARATOR

Platelet-poor plasma

Procedure: Platelet-rich plasmaProcedure: Platelet-poor plasma

Interventions

Platelet-rich plasmaPROCEDURE

Platelet-rich plasma injection

ExperimentalPlatelet-poor plasma
Platelet-poor plasmaPROCEDURE

Platelet-poor plasma injection

ExperimentalPlatelet-poor plasma

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, 46113, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Ignacio Pérez, PhD

    Cardenal Herrera University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial (Parallel Assignment)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 7, 2018

Study Start

June 5, 2018

Primary Completion

November 5, 2018

Study Completion

November 5, 2018

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

ES(1)