Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-27 @ 8:41 AM
Study NCT ID:
NCT03548259
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Sponsor:
Cardenal Herrera University
Organization:
Study Overview
Official Title:
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRP-CTS
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: