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

• Sponsor: Dalia Salah Saif (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04235426
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 36.2
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel	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.; Procedure: 30 patients went to surgical procedure; Other: Injection	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Platelet Rich Plasma Injection Versus Surgical and Medical Treatment of Mild-moderate Carpel Tunnel Syndrome.
• Actual Study Start Date: Jan 26, 2018
• Anticipated Primary Completion Date: Jan 31, 2021
• Anticipated Study Completion Date: Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: surgical group. 30 patients went to the surgical release of carpal tunnel.	Procedure: 30 patients went to surgical procedure; 30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.
Experimental: 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.	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.
Experimental: injection group. Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments	Other: Injection; Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments; Other Names: PRP injection.

Outcome Measures

Primary Outcome Measures

1. 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)

2. Electrophysiological study of median nerve. [at baseline and at 3 and 6 months post injection.]

   motor and sensory conductive of the median nerve.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dalia Saif	Cairo		Egypt	11311

Sponsors and Collaborators

• Dalia Salah Saif

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dalia Salah Saif, principle investigator, Menoufia University
• ClinicalTrials.gov Identifier: NCT04235426
• Other Study ID Numbers: 1472
• First Posted: Jan 21, 2020
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Vitamin B 12; Hydroxocobalamin; Diclofenac

Study Results

No Results Posted as of Jan 22, 2020