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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Platelet-rich plasma injection
Platelet-poor plasma injection
Universidad CEU Cardenal Herrera
Valencia, Spain
Hand grip strength
Hand grip strength measured with dynamometer
Time frame: 6 weeks
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.