Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial (PRP-CTS)
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Platelet-rich plasma
Platelet-poor plasma
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Platelet-rich plasma, Surgery
Eligibility 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
Sites / Locations
- Universidad CEU Cardenal Herrera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Platelet-poor plasma
Arm Description
Platelet-rich plasma
Platelet-poor plasma
Outcomes
Primary Outcome Measures
Hand grip strength
Hand grip strength measured with dynamometer
Secondary Outcome Measures
Pain
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".
Sympton severity
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.
Functional status
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.
Wound healing
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.
Full Information
NCT ID
NCT03548259
First Posted
May 24, 2018
Last Updated
February 1, 2019
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT03548259
Brief Title
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Acronym
PRP-CTS
Official Title
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Platelet-rich plasma, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial (Parallel Assignment)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Platelet-rich plasma
Arm Title
Platelet-poor plasma
Arm Type
Placebo Comparator
Arm Description
Platelet-poor plasma
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Platelet-rich plasma injection
Intervention Type
Procedure
Intervention Name(s)
Platelet-poor plasma
Intervention Description
Platelet-poor plasma injection
Primary Outcome Measure Information:
Title
Hand grip strength
Description
Hand grip strength measured with dynamometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
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".
Time Frame
6 weeks
Title
Sympton severity
Description
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.
Time Frame
6 weeks
Title
Functional status
Description
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.
Time Frame
6 weeks
Title
Wound healing
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Pérez, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Valencia
ZIP/Postal Code
46113
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
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