Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, Platelet-rich plasma, Surgery
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.
Interventions
PROCEDUREPlatelet-rich plasma
Platelet-rich plasma injection
PROCEDUREPlatelet-poor plasma
Platelet-poor plasma injection
Sponsors
Cardenal Herrera University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Randomized Controlled Trial (Parallel Assignment)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip strength | 6 weeks | Hand grip strength measured with dynamometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed