Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Procedure: Platelet-rich plasmaProcedure: Platelet-poor plasma
- Registration Number
- NCT03548259
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients with Carpal Tunnel Syndrome (CTS)
- Conservative treatment failure
- Previous CTS surgery on the same side
- Wrist fracture/trauma in history
- Polyneuropathy
- Diabetes mellitus
- Cervical neuropathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Platelet-rich plasma Platelet-rich plasma Experimental Platelet-poor plasma Platelet-rich plasma Platelet-poor plasma Platelet-rich plasma Platelet-poor plasma Platelet-poor plasma Platelet-poor plasma Platelet-poor plasma
- Primary Outcome Measures
Name Time Method Hand grip strength 6 weeks Hand grip strength measured with dynamometer
- Secondary Outcome Measures
Name Time Method Functional status 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.
Pain 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".
Sympton severity 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.
Wound healing 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.
Trial Locations
- Locations (1)
Universidad CEU Cardenal Herrera
🇪🇸Valencia, Spain