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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Platelet-rich plasma
* Procedure: Platelet-poor plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial (Parallel Assignment)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Platelet-rich plasma | Procedure: Platelet-rich plasma<br>* Platelet-rich plasma injection<br>Procedure: Platelet-poor plasma<br>* Platelet-poor plasma injection<br>|
| Placebo Comparator: Platelet-poor plasma<br>Platelet-poor plasma | Procedure: Platelet-rich plasma<br>* Platelet-rich plasma injection<br>Procedure: Platelet-poor plasma<br>* Platelet-poor plasma injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | Hand grip strength measured with dynamometer | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 
| 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. | 6 weeks | 
| 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. | 6 weeks | 
| 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Carpal Tunnel Syndrome, Platelet-rich plasma