Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2020
INTERVENTION: The patients were randomly categorized a in 1:1:1 ratio into three groups PRP (i) group, PRP (ii) group and a third group (CS) that received local corticosteroid injection. Randomization was done by an independent researcher via computer generated randomization of study numbers on Excel® 2007 (Microsoft Co., Redmond, WA, USA). The clinical examination and nerve conduction study were done by a researcher who was blind to the type of the given injection. Three peripheral venous blood samples were collected aseptically from each subject from the PRP groups into tubes with sodium citrate as an anticoagulant (BD® vacutainer). Whole blood platelet counts were determined using the cell counter (Sysmex Kx‐21, Japan). In order to prepare PRP, the laboratory bench‐top centrifuge (NÜVE: NF 400) was used at two different centrifugation times and rotation per minutes (rpm). PRP (i) was separated by a single centrifugation step at 1600 rpm for 8 min, and then the plasma above the erythrocyte layer was collected immediately. PRP (ii) was separated by two steps of centrifugation procedures. The samples were centrifuged first at 1200 rpm for 10 min; the plasma was separated from packed red blood cells and re‐centrifuged at 3700 rpm for 10 min. The upper two‐third volume of plasma, which is poor in platelets, was removed; the platelet pellet was suspended in a minimum quantity of plasma by gently shaking the tube and the PRP was activated endogenously the soft tissue collagen. The remnant PRP was counted using the cell counter (Sysmex Kx‐21, Japan). The mean of platelet counts after each method was calculated and the enrichment percentage was determined as follows: Platelet enrichment = (platelet count PRP ‐ platelet count whole blood)/platelet count whol CONDITION: Carpal tunnel syndrome ; Nervous System Diseases PRIMARY OUTCOME: ; 1. Pain assessed using a 1‐10 visual analogue scale (VAS) reported by the patient at at 1.5 and 3 months after injection; 2. Symptom severity assessed using the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) at time of diagnosis and at 1.5 and 3 months after injection of treatment; 3. Functional outcome assessed using the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) at time of diagnosis and at 1.5 and 3 months after injection of treatment; ; BCTSQ evaluates two domains of CTS: (i) symptoms severity using a scale of 11 items (pain, paresthesia, numbness, weakness and nocturnal symptoms), and (ii) functional assessment using a scale of eight items (writing, buttoning, holding, gripping, bathing and dressing). The questionnaire is in a multiple choice format with scores ranging from 1 (mildest) to 5 (most severe). Each score was calculated as the mean of the response of the individual items.; INCLUSION CRITERIA: 1. Diagnosed with very mild to moderate unilateral CTS 2. Aged 18‐65 years SECONDARY OUTCOME: ; Electrophysiological grading of CTS assessed using a nerve conduction velocity test at diagnosis and 1.5 and 3 months after injection of treatment; ; The electrophysiological study was conducted as per the American Association of Electrodiagnostic Medicine protocol by an expert neurologist. According to the neurophysiological grading for CTS, patients were classified as follows: very mild (grade 1), CTS confirmed only with most sensitive tests (e.g., inching, combined sensory index, palm/wrist median/ulnar comparison); mild (grade 2), only orthodromic sensory nerve conduction velocity slow at <40 m/s with normal terminal motor latency; moderate (grade 3), motor terminal latency >4.5 ms and <6.5 ms with preserved sensory nerve action potential of the index finger.;
Epistemonikos ID: 1021b8aff4271ce5b83138748032c2a27f20edaa
First added on: Aug 24, 2024