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

Carpal Tunnel Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04235426
• Other study ID #: 1472
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 26, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: January 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome

Intervention

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.
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.

Procedure:
• 30 patients went to surgical procedure
30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.

Other:
• Injection
Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments

Locations

Country	Name	City	State
Egypt	Dalia Saif	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dalia Salah Saif

Country where clinical trial is conducted

Egypt, 

Outcome

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