Neck PainNCT06480175
Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of Cervical Spondylosis Pain
A study testing cervical plexus block in people with Neck Pain and Cervical Spondylosis, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Neck Pain, Cervical Spondylosis
- What is being tested?
- cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
lydia E zakhary, 01222555128, lydia_zakhary@med.asu.edu.eg
About this study
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
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 ?
Read the 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.
- Conditions
- Neck Pain, Cervical Spondylosis
- Being tested
- cervical plexus block
- Medical subject headings
- Neck Pain, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical plexus blockProcedure or surgery
Also called radiofrequency ablation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 months
Secondary outcomes (2)
improved life style
Secondary outcomes that will be detected in our study is the degree of pain releif after 6 months 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 .
- change the need for the use of oral or parentral analgesics
Measured: 6 months
global impression of change
measuring patient global impression of change ( PGIC) score: PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." where score 1 indicating " very much improved " and 7 indicating " very much worse".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start20 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
- Investigators
- lydia zakhary, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480175
- Sponsor's protocol ID
- neck pain
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34336626Burnham 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.
PubMed 32022889
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480175
- Acronym / sponsor ID
- neck pain
- Conditions
- Neck Pain, Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical plexus block | Experimental | Procedure: cervical plexus blockpatients 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical plexus blockAlso: radiofrequency ablationpatients 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 | Procedure or surgery | cervical plexus block |
Primary outcome
pain releif
Time frame: 1 months
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
2 secondary outcomes
improved life style
Time frame: 6 months
global impression of change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 34336626Berger 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.
- Background: PubMed 32022889Burnham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lydia zakhary, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical plexus block in people with Neck Pain and Cervical Spondylosis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lydia zakhary (01222555128, lydia_zakhary@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain releif (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.