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

Primary Purpose

Carpal Tunnel

Status

Unknown status

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

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 went to surgical procedure

Injection

About this trial

This is an interventional treatment trial for Carpal Tunnel

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

pregnancy.
history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.).
history of local corticosteroid injection in the past 3 months.
atrophy of thenar muscles.
previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy.
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.

Sites / Locations

Dalia Saif

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

surgical group.

medical group.

injection group.

Arm Description

30 patients went to the surgical release of carpal tunnel.

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.

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

Outcomes

Primary Outcome Measures

VAS (Visual Analogue Scale),

The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)

Electrophysiological study of median nerve.

motor and sensory conductive of the median nerve.

Secondary Outcome Measures

Full Information

NCT ID

NCT04235426

First Posted

January 17, 2020

Last Updated

January 18, 2020

Sponsor

Dalia Salah Saif

1. Study Identification

Unique Protocol Identification Number

NCT04235426

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 26, 2018 (Actual)

Primary Completion Date

January 31, 2021 (Anticipated)

Study Completion Date

January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dalia Salah Saif

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

surgical group.

Arm Type

Experimental

Arm Description

30 patients went to the surgical release of carpal tunnel.

Arm Title

medical group.

Arm Type

Experimental

Arm Description

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.

Arm Title

injection group.

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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.

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

30 patients went to surgical procedure

Intervention Description

30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.

Intervention Type

Other

Intervention Name(s)

Injection

Other Intervention Name(s)

PRP injection.

Intervention Description

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

Primary Outcome Measure Information:

Title

VAS (Visual Analogue Scale),

Description

The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain)

Time Frame

at baseline and at 3 and 6 months post injection.

Title

Electrophysiological study of median nerve.

Description

motor and sensory conductive of the median nerve.

Time Frame

at baseline and at 3 and 6 months post injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: pregnancy. history of underlying metabolic diseases (such as diabetes mellitus, thyroid diseases, rheumatoid arthritis and etc.). history of local corticosteroid injection in the past 3 months. atrophy of thenar muscles. previous carpal tunnel release surgery and evidence of concomitant neuropathy or radiculopathy. 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.

Facility Information:

Facility Name

Dalia Saif

City

Cairo

ZIP/Postal Code

11311

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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