Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of Cervical Spondylosis Pain

NCT06480175 | Recruiting DMC

• 1 other identifier: neck pain
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness in the pain relief between doing radiofrequency ablation for the medial branch of the cervical facet pain alone vs using it combined with superficial cervical plexus block.in adults patients with cervical spondylosis pain The main question it aims to answer is: does adding superficial cervical plexus block to radiofrequency in patients with chronic neck pain provide better analgesia than radioprequency alone ?

Conditions

Neck Pain; Cervical Spondylosis

Outcome Measures

Primary Outcomes (1)

• pain releif

  evaluating degree of pain releif after cervical medial branch radiofrequency ablation Monitoring pain score using numeric pain rating scale (NPRS) it is a 11 point scale scored from 0-10 * 0 represents no pain * 10 represents the worst pain imaginable . versus radiofrequency plus superficial cervical plexus block by using numeric pain rating scale after 1 month

  1 months

Secondary Outcomes (2)

• improved life style

  6 months

• global impression of change

  6 months

Study Arms (1)

cervical plexus block

EXPERIMENTAL

patients will receive cervical radiofrequency nerve ablation on both sides and after 2 weeks will be readmitted and will receive superficail cervical plexus block on only one side

Procedure: cervical plexus block

Interventions

cervical plexus block PROCEDURE

patients will receive cervical radiofrequency ablation on both sides then after 2 weeks they will be readmitted and will receive superficial cervical plexus block on one side only

Also known as: radiofrequency ablation

cervical plexus block

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders.
• Age between 30-70 years.
• American society of anesthesiologist ASA 1,2 \& 3 physical status.
• MRI cervical spine diagnosing cervical facet arthropathy originating pain .
• Failed full dose medical treatment and life style modification and physiotherapy for 3 months prior to intervention.

You may not qualify if:

• Neurological disorders.(previous central and peripheral CNS affection ).
• coagulopathy INR \> 1.8 or platelets \< 50,000.
• Infection at or near the injection site.
• Presence of pacemaker or defibrillator.
• known allergy to used medications.
• age \>70 or \<30 years.
• patients with previous history of Radiotherapy , chemotherapy or metastasis
• pregnant patients.
• patients with rheumatological disorders ( rheumatoid arthritis, diffuse idiopathic skeletal hyerostosis, psoriatic arthritis, spondyloarthritis)
• patients with antiphospholipid syndtrome.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

Related Publications (2)

• Berger AA, Liu Y, Mosel L, Champagne KA, Ruoff MT, Cornett EM, Kaye AD, Imani F, Shakeri A, Varrassi G, Viswanath O, Urits I. Efficacy of Dry Needling and Acupuncture in the Treatment of Neck Pain. Anesth Pain Med. 2021 Apr 3;11(2):e113627. doi: 10.5812/aapm.113627. eCollection 2021 Apr.

  PMID: 34336626 BACKGROUND

• Burnham T, Conger A, Salazar F, Petersen R, Kendall R, Cunningham S, Teramoto M, McCormick ZL. The Effectiveness of Cervical Medial Branch Radiofrequency Ablation for Chronic Facet Joint Syndrome in Patients Selected by a Practical Medial Branch Block Paradigm. Pain Med. 2020 Oct 1;21(10):2071-2076. doi: 10.1093/pm/pnz358.

  PMID: 32022889 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Spondylosis

Interventions

Cervical Plexus Block; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• lydia zakhary, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lydia zakhary

CONTACT

01222555128; lydia_zakhary@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 28, 2024
• Study Start: June 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

EG (1)