Radiofrequency, Perineural Injection, Idiopathic Carpal Tunnel Syndrome

NCT05053477 | Unknown Phase 1 DMC

• 1 other identifier: 1216-4-009
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Aim of the study The aim of the study is to evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome Patients will be classified into three equal groups using randomized closed envelop method into three groups. Control Group ( n=25):Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance. PRF Group ( n=25):Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance PRP Group (n=25): Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance Measurements (will be done before the procedure, one week ,two month and four months after procedure except SNCV and serum CRP and TNF α (tumor necrosis factor alpha)will be done before the procedure and after four months only):

1. 1.VAS (visual analogue pain scale)
2. 2.BCTQ (Boston carpal tunnel Questionnaire)
3. 3.Degree of paresthesia tested by Reverse Phalen's test.
4. 4.CSA (cross sectional area)0 of the median nerve will be measured by the same pain therapist involved in the study.
5. 5.SNCV (nerve conduction velocity study): performed by same physiotherapist not involved in the study before and after intervention.
6. 6.Serum Tumor necrosis factor alpha (TNF α).
7. 7.C-reactive protein (CRP)
8. 8.Complications will be recorded and managed. Items 1,2 and 3 will be measured by a pain therapist not involved in this study

Conditions

Carpal Tunnel Syndrome

Keywords

CTS, Platelet Rich Plasma, Pulsed Radiofrequency

Outcome Measures

Primary Outcomes (2)

• Evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome

  We will evaluate the median nerve by NCV to all participant

  four month

• Evaluate effect of pulsed radiofrequency versus platelet rich plasma injection on pain mediators

  We will measure the level of TNF to all participant

  four month

Secondary Outcomes (2)

• Pain relief assessment

  four month

• Numbness relief assessment

  four month

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance

Drug: mehylprednisolone injection

PRF Group

ACTIVE COMPARATOR

Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance

Device: pulsed radiofrequency (PRF)

PRP Group

ACTIVE COMPARATOR

Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance

Biological: platelet-rich plasma

Interventions

mehylprednisolone injection DRUG

(40 mg)

Also known as: Group A

Control Group

pulsed radiofrequency (PRF) DEVICE

. PRF lesion will be carried out for 120 seconds at a 2 Hz frequency and pulse width of 20 ms at 42°C

Also known as: Group B

PRF Group

platelet-rich plasma BIOLOGICAL

2 ml of PRP

Also known as: Group C

PRP Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged (30-50) years of both gender.
• Patients with mild to moderate idiopathic CTS.
• Patient who are failed to respond to conservative treatment (such as splint, medications, physical therapy) for at least three months

You may not qualify if:

• Severe CTS and secondary CTS

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Medical Research Institute

Alexandria, Alex, 123456, Egypt

RECRUITING

Medical Research Institute

Alexandria, 123456, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• engy yousry, MD

  STAFF

  STUDY DIRECTOR

Central Study Contacts

shamandy

CONTACT

01224612361; fot1987@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: December 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after finishing the thesis for life long
• Access Criteria: Digital Library Unit-Alexandria University

Locations

EG (2)