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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04235426
Other study ID # 1472
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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