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Radiofrequency, Perineural Injection, Idiopathic Carpal Tunnel Syndrome

NCT05053477 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-09-29

No results posted yet for this study

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

Interventions

DRUG

mehylprednisolone injection

(40 mg)

DEVICE

pulsed radiofrequency (PRF)

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

BIOLOGICAL

platelet-rich plasma

2 ml of PRP

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • engy yousry, MD · STAFF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2022-11-30
Completion
2023-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053477 on ClinicalTrials.gov