Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.

Phase 1

• Conditions: Carpal Tunnel
• Interventions: Other: Injection; Procedure: 30 patients went to surgical procedure; Drug: 30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

• Registration Number: NCT04235426
• Lead Sponsor: Dalia Salah Saif

Brief Summary

to evaluate the therapeutic efficacy of single ultrasound guided Platelet Rich Plasma injection of the carpal tunnel Vs. surgical procedures and medical treatment and hand support in patients with mild-moderate carpal tunnel syndrome regarding pain relief and function improvement during a follow up period of 6 months.

Detailed Description

Carpal tunnel syndrome (CTS) accounts for approximately 90% of peripheral entrapment neuropathy cases. Existing evidence based treatments for carpal tunnel syndrome, splinting, corticosteroid injection and surgery, are not 100% effective and alternative treatments are worth exploring .Surgery indicated in Patients with persistent numbness and pain, motor dysfunction with diminished grip or pinch grasping, or thenar eminence flattening. Empirical evidence indicates that many patients with CTS have self-limiting symptoms and respond to splinting and anti-inflammatory medications. Recently major attention has been drawn to platelet-rich plasma for its possible effects on axon regeneration and neurological recovery.

Study Timeline

• Study Start: 2018-01-26
• Status Verified: 2020-01
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-18
• Study First Posted: 2020-01-21
• Last Update Posted: 2020-01-22
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patients with signs and symptoms of CTS and a confirmed diagnosis of mild and moderate CTS based on clinical and electrophysiological studies were included.

Exclusion Criteria

1. pregnancy.
2. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
3. history of local corticosteroid injection in the past 3 months.
4. atrophy of thenar muscles.
5. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
6. Patients with autoimmune or hematologic disorders, NSAID consumption 2 days prior to injection, treatment with antiplatelet and anticoagulant agents, Hb level under 12 g/dl, and platelet count under 150,000 in ml.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
injection group.	Injection	Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments
surgical group.	30 patients went to surgical procedure	30 patients went to the surgical release of carpal tunnel.
medical group.	30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.	30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.

Primary Outcome Measures

Name	Time	Method
VAS (Visual Analogue Scale),	at baseline and at 3 and 6 months post injection.	The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)
Electrophysiological study of median nerve.	at baseline and at 3 and 6 months post injection.	motor and sensory conductive of the median nerve.

Trial Locations

Locations (1)

Dalia Saif; 🇪🇬 Cairo, Egypt