Comparing platelet-rich plasma extracted from a patient's own blood with corticosteroid injections in the treatment of carpal tunnel syndrome

Not Applicable

Completed

• Conditions: Carpal tunnel syndrome; Nervous System Diseases

• Registration Number: ISRCTN16755281
• Lead Sponsor: Zagazig University

Brief Summary

2020 Results article in https://doi.org/10.1186/s41983-020-00184-1 (added 20/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-15
• Study Start: 2020-03-20
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosed with very mild to moderate unilateral CTS
2. Aged 18-65 years

Exclusion Criteria

1. Severe CTS
2. Bilateral CTS
3. Received non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of the study start
4. History of wrist surgery, polyneuropathy, cervical spondylosis, brachial plexopathy or thoracic outlet syndrome
5. History of thrombocytopenia or platelet dysfunction
6. Systemic infection
7. Renal or hepatic disease
8. Pregnancy
9. Previous steroid injection or surgical treatments for CTS
10. Psychiatric disorders or serious mental stress
11. Use of corticosteroid or anticlotting drugs
12. Diabetes mellitus
13. Uncontrolled hypothyroidism
14. Rheumatological disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pain assessed using a 1-10 visual analogue scale (VAS) reported by the patient at at 1.5 and 3 months after injection<br> 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<br> 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<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Electrophysiological grading of CTS assessed using a nerve conduction velocity test at diagnosis and 1.5 and 3 months after injection of treatment<br><br> 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.<br>