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

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ClinicalTrials.gov Identifier: NCT03548259
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Platelet-rich plasma Procedure: Platelet-poor plasma Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial (Parallel Assignment)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018


Arm Intervention/treatment
Experimental: Experimental
Platelet-rich plasma
Procedure: Platelet-rich plasma
Platelet-rich plasma injection

Procedure: Platelet-poor plasma
Platelet-poor plasma injection

Placebo Comparator: Platelet-poor plasma
Platelet-poor plasma
Procedure: Platelet-rich plasma
Platelet-rich plasma injection

Procedure: Platelet-poor plasma
Platelet-poor plasma injection




Primary Outcome Measures :
  1. Hand grip strength [ Time Frame: 6 weeks ]
    Hand grip strength measured with dynamometer


Secondary Outcome Measures :
  1. Pain [ Time Frame: 6 weeks ]
    Pain measured with the Wong-Baker Faces Pain Rating Scale. The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst".

  2. Sympton severity [ Time Frame: 6 weeks ]
    Sympton severity measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire. The Symptom Severity Scale (SSS) contains 11 questions and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.

  3. Functional status [ Time Frame: 6 weeks ]
    Functional status measured with the sympton severity scale of the Boston Carpal Tunnel Syndrome Questionnaire.The Functional Status Scale (FSS) contains 8 items and uses a five-point rating scale that generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.

  4. Wound healing [ Time Frame: 6 weeks ]
    Wound healing measured with the Southampton Wound Assessment Scale. Wounds are scored as 0, I, II, III, IV and V, with a higher score indicating worst healing.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548259


Locations
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Spain
Universidad CEU Cardenal Herrera
Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Study Chair: Ignacio Pérez, PhD Cardenal Herrera University

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Responsible Party: Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03548259     History of Changes
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-18
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan F. Lisón Párraga, Dr, Cardenal Herrera University:
Carpal Tunnel Syndrome
Platelet-rich plasma
Surgery

Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries