Clinical trial NCT06480175: Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of Cervical Spondylosis Pain
Official title: Comparative Study Between Cervical Medial Branch Radiofrequency Ablation Versus Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of the Cervical Facet and Cervical Spondylosis Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Cervical Spondylosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 ?

Detailed description: participants will be placed in prone position with neck preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radiofrequency machine will be placed on the back ( the Neurotherm NT1100 regenerator will be used) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry.

The entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the radiofrequency cannula (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the medial branches supplying C4, C5, C6 \& C7 bilateral.

the investigators will use 1 entry site for each side and then redirect the needles .

Confirmation of the appropriate location will be done on fluoroscopy in both A-P and lateral views Once targeted, sensory stimulation will be done and every patient is asked if he feels the same pain as that he used to suffer from. Once confirmed with absence of motor response; 1 more ml of lidocaine 20 % is injected and then start our ablation for 180 sec at 80 degrees

The procedure will be done bilateral the same. After 2 weeks , patient will be readmitted and then the investigators will choose to inject the superficial cervical plexus with 5 ml of lidocaine 20% plus 40 mg triamcinolone. injection was random in the right or left side using ultrasound to confirm success.

The side of the block will be recorded for each patient either right or left. Comparison will be done between both sides to study the effect of adding superficial plexus block to radio-frequency whether the analgesic effect is better on the side of radio frequency alone or the side where the superficial cervical plexus block was added to radio-frequency.

The patients will then be asked to be followed up after 1 month and after 6 months and about the improvement in the numeric pain score (NPS) and the patient global impression of change (PGIC) and if they feel that one side is better than the other or they feel the same. Visual analogue score scale will be recorded for documentation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: pain releif
timeFrame: 1 months
Secondary outcomes:
measure: improved life style
timeFrame: 6 months
measure: global impression of change
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ain Shams University
name: lydia zakhary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.