Pain;Back Low;ChronicRaFrNCT05624307
Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
An observational study of Pain;Back Low;Chronic, run by FondationbHopale at 1 site in France.
Trial summary
Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain;Back Low;Chronic
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2022to 15 May 2024
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in the study were major patients with chronic low back pain. The patients included in the study will have to respond to 5 questionnaires at 1 month, 3 months and 6 months according to the frequency of post-treatment consultation with RT-NF.
Who may be able to join
- Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment
- Age 18 - 65 years
- Patient did not object to the use of their data
- Patient affiliated to a social security plan
- Non inclusion Criteria:
- Patient with a disorder of hemostasis
Show all 16Show fewer
- Patient with a history of arthrodesis
- Patient with radiologically visible root damage
- Patient with instability of the spine
- Patient with an abnormality on dorso-lumbar MRI: MODIC 1
- Patient under legal protection :
- Person under guardianship,
- Person under curatorship,
- Person under legal protection,
- Person deprived of liberty,
- Pregnant or breastfeeding woman
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bruno VEYS
Berck, Hauts-de-France, 62608
Bruno VEYS, 0362882747, Bruno.veys@fondation-hopale.org
Marine DESEUR, 0362882780, marine.deseur@fondation-hopale.org
About this study
Official title: Relevance of the Combined Extension-rotation-lateral Tilt Maneuver in the Selection of Patients With Chronic Low Back Pain for Neurotnomy Intervention Radiofrequency : Pilot Study
Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required.
Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin. It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure.
Read more
The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain.
The included patients will answer 5 questionnaires, in addition to the usual clinical data:
- Hospital Anxiety and Depression scale (HAD) questionnaire,
- Quality of life questionnaire EQ-5D-5L,
- Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD),
- Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability Scale
- Clinical Global Impression of Change (CGI-C)
- Conditions
- Pain;Back Low;Chronic
- Keywords
- Radiofrequency, Facet pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with chronic back pain | Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief-Pain Inventory (BPI)
Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI), is reduced by 50% at 1 month compared to the preoperative workup, and non-responders if the pain score did not reduce sufficiently or if the response to block tests was negative.
Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Measured: Pre-operative evaluation, at 1 month
Secondary outcomes (4)
The Quebec Back Pain Disability Scale.
It is a self-assessment scale of disability, which deals with the impact on daily life and low back pain. It has 20 items, scored from 0 to 5, giving an overall score. The higher the score, the greater the functional impact of low back pain. This scale is validated in French.
Measured: Pre-operative evaluation then at 1, 3 and 6 months post intervention
Questionnaire Hospital Anxiety and Depression scale (HAD)
The Hospital Anxiety and Depression scale (HAD) questionnaire is used to screen for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score: 21). A score close to 0 means no anxiety symptoms a score close to 11 and above indicates anxiety symptoms. This scale is validated in French.
Measured: Pre-operative evaluation then at 1, 3 and 6 months post intervention
EQ-5D-5L Questionnaire
The EQ-5D-5L consists essentially of 2 pages: the EQ-5D descriptive system and the EQ Visual Analog Scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' scored 100 and 'The worst health you can imagine' scored 0. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Pre-operative evaluation then at 1, 3 and 6 months post intervention
Brief-Pain Inventory (BPI)
Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI). Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Evolution of BPI scores at 3 and 6 months in patients who responded to treatment at 1 month
Measured: 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start21 Nov 2022
- Primary completion15 Nov 2023 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain;Back Low;ChronicStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas OLIVIERI, Principal investigator, Hopale Foundation - Calot Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624307
- Sponsor's protocol ID
- HOP22-RIPH3-02
- Acronym
- RaFr
- Status last verified
- Oct 2022
- First submitted
- 14 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Combined Extension-rotation-lateral Tilt Maneuver in the Selection of Patients With Chronic Low Back Pain for Neurotnomy Intervention Radiofrequency : Pilot Study
- ClinicalTrials.gov ID
- NCT05624307
- Acronym / sponsor ID
- RaFr / HOP22-RIPH3-02
- Conditions
- Pain;Back Low;Chronic
- Keywords
- Radiofrequency, Facet pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 22 Nov 2022 (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.
Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required.
Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin. It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure.
The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain.
The included patients will answer 5 questionnaires, in addition to the usual clinical data:
- Hospital Anxiety and Depression scale (HAD) questionnaire,
- Quality of life questionnaire EQ-5D-5L,
- Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD),
- Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability Scale
- Clinical Global Impression of Change (CGI-C)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic back pain | – | –Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study were major patients with chronic low back pain. The patients included in the study will have to respond to 5 questionnaires at 1 month, 3 months and 6 months according to the frequency of post-treatment consultation with RT-NF.
Key inclusion criteria (16 listed)
- Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment
- Age 18 - 65 years
- Patient did not object to the use of their data
- Patient affiliated to a social security plan
- Patient with a disorder of hemostasis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief-Pain Inventory (BPI)
Time frame: Pre-operative evaluation, at 1 month
Patients will be considered responders if the pain score, estimated by the Brief-Pain Inventory (BPI), is reduced by 50% at 1 month compared to the preoperative workup, and non-responders if the pain score did not reduce sufficiently or if the response to block tests was negative. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
4 secondary outcomes
The Quebec Back Pain Disability Scale.
Time frame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
Questionnaire Hospital Anxiety and Depression scale (HAD)
Time frame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
EQ-5D-5L Questionnaire
Time frame: Pre-operative evaluation then at 1, 3 and 6 months post intervention
Brief-Pain Inventory (BPI)
Time frame: 3 and 6 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas OLIVIERI principal investigator
Hopale Foundation - Calot Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain;Back Low;Chronic, run by FondationbHopale at 1 site in France.
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 16 inclusion and 0 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 12 Dec 2022. 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 France. 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 Bruno VEYS (0362882747, Bruno.veys@fondation-hopale.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief-Pain Inventory (BPI) (time frame: Pre-operative evaluation, at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2022.