A Prospective Comparative Study on the Efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- The visual analog scale (VAS)
Study Overview
Brief Summary
The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:
- Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
- Asses safety profile of both methods
Participants will:
- Randomized to one of the two arms
- Visit the clinic 1 and 3 months after intervention
- Assessed for efficacy and safety of the intervention
Detailed Description
The medical records of patients diagnosed with carpal tunnel syndrome will be reviewed using a computerized carpal tunnel syndrome sheet including all variables for each patient assessing the symptoms and the functional condition by assessing changes in the usual daily routines. The assessment of the patients was done before and after the intervention (1 and 3 months later).
The CSA is obtained (in mm² at distal wrist crease) using ultrasound. Then the CTS grading was determined via US staging 9-13, 13-15, >15 as mild, moderate and severe respectively.
Ultrasound-Guided Intracarpal Injection. High-resolution US examination will be done by using a GE Logiq E9 with ML6-15-D Matrix linear array probe (USA). Under sterile conditions, a 25-gauge needle will be used using ulnar approach and under real time visualization the needle will be guided to the superficial ulnar aspect of the median nerve. The patients will be randomized into two groups
PRP group:
whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed clinically as carpal tunnel syndrome with at least 3 months of symptoms and confirmed electro-physiologically as carpal tunnel syndrome
Exclusion Criteria
- •Onset of carpal tunnel syndrome during pregnancy
- •Co-existence of brachial plexopathy or thoracic outlet syndrome by clinical examination
- •Previous carpal tunnel decompressive surgery or corticosteroid injection in carpal tunnel
- •Patients with infection or local edema at the site of injection.
Outcomes
Primary Outcomes
The visual analog scale (VAS)
Time Frame: before the intervention,1 and 3 months after intervention
The Visual Analogue Scale (VAS) is a simple assessment tool used to measure pain intensity. The VAS consists of a straight horizontal line, usually 10 centimetres (cm) in length. One end of the line represents "no pain," while the other end represents "the worst pain ever experienced." Patients are asked to rate their current level of pain by placing a mark on the line. Using a ruler, the score is determined by measuring the distance (in millimetres) from the "no pain" anchor to the patient's mark. The resulting score ranges from 0 to 100, with a higher score indicating greater pain intensity.
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time Frame: before the intervention,1 and 3 months after intervention
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a patient-based questionnaire, consists of two main scales: Symptom Severity Scale (SSS): Measures the severity of symptoms related to CTS. Functional Status Scale (FSS): Assesses functional limitations caused by CTS. Each scale contains several items, and patients rate their symptoms or functional difficulties on a scale from 1 to 5. A score of 1 indicates no symptoms or functional difficulty. A score of 5 represents maximum symptoms or inability to perform the task1. Interpretation: Higher scores on both scales indicate worse symptoms or greater functional impairment due to CTS.
Secondary Outcomes
- The cross-sectional area (CSA) of the Median nerve(before the intervention and 3 months after intervention)
Investigators
Osama Ahmed Elshafei
lecturer of neurology
Mansoura University