Low Back PainPhase 4FACETNCT03339362
FAcet-joint Injection Clinical and Cost-effective Trial
A Phase 4 study testing Active Procedure in people with Low Back Pain, run by Barts & The London NHS Trust at 3 sites in United Kingdom.
Trial summary
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may cause persistent low back pain, with significant socioeconomic impact. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Active Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2015to 15 May 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
- Low back pain of greater than three months' duration.
- Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
- Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
- At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture, and manual therapy.
Who cannot join
- Patient refusal.
- More than four painful lumbar facet-joints.
- Patient has not completed at least two components of NICE-recommended best non-invasive care.
- 'Red flag' signs ('Red flag' signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
- Hypersensitivity to study medications or X-ray contrast medium.
- Radicular pain (Radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band).
Show all 19Show fewer
- Dominantly midline tenderness over the lumbar spine.
- Any other dominant pain.
- Any major systemic disease or mental health illness that may affect the patient's pain, disability and/or their ability to exercise and rehabilitate.
- Any active neoplastic disease, including primary or secondary neoplasm.
- Pregnant or breastfeeding patients.
- Previous lumbar facet-joint injections.
- Previous lumbar spinal surgery.
- Patients with morbid obesity (body mass index of 35 or greater).
- Major trauma or infection to the lumbar spine.
- Participation in another clinical trial in the past thirty days.
- Patients unable to commit to the six-month study duration.
- Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
- Patients with a history of substance abuse.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
Barts Health NHS Trust
London, EC1A 7BE
About this study
Official title: A Multicentre Double-blind Randomised Controlled Trial to Assess the Clinical- and Cost-effectiveness of Facet-joint Injections in Selected Patients With Non-specific Low Back Pain: a Feasibility Study
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may cause persistent low back pain, with significant socioeconomic impact. At present, there is insufficient high quality evidence to support the use of lumbar facet-joint injections (FJIs) in treating low back pain of less than 12 months' duration; the National Institute for Health and Care Excellence (NICE) therefore did not approved their use in their 2009 publication.
This study will investigate the feasibility of conducting a larger, definitive trial to assess lumbar FJIs (a needle is inserted into the facet-joint and steroid injected), by comparing it to a dummy or 'sham' procedure (a needle is inserted near the facet-joint but no therapeutic substance injected).
Read more
Patients with persistent low back pain, referred to a community or hospital-based pain, spinal or musculoskeletal clinic by their general practitioner, will be reviewed and assessed by a specialist physician. They will be screened and recruited based on clinical history and examination. Participants will receive diagnostic injections (medial branch nerve blocks); those with a positive response will randomly receive either FJIs or a sham procedure, under x-ray guidance. All participants will receive a combined physical and psychological programme recommended by NICE as a strategy to reduce pain and its impact on the person's day-to-day life, even if the pain cannot be cured completely.
Participants will be asked to complete questionnaires comparing a range of pain and disability-related issues. These will occur at baseline (before treatment) and at 6 weeks, 3 months and 6 months after their injections.
Criteria for the study to be considered successful (and a definitive trial feasible) include the abilities to standardise the methods for injection and to recruit and retain sufficient participants, and the acceptability of the study design to participants and clinicians.
Read the detailed description
Design
This study seeks to examine the feasibility of undertaking a fully powered double-blind randomised controlled trial. Patients with non-specific low back pain of more than three months' duration with confirmed facet-joint disease will be individually randomised 1:1 to receive facet-joint injections plus a combined physical and psychological programme (intervention group) or to a sham (placebo) procedure plus a combined physical and psychological programme (control group).
Setting
The feasibility study will be conducted in three hospital-based pain medicine centres: Barts Health NHS Trust (formerly Barts and The London NHS Trust), Basildon and Thurrock University Hospitals NHS Foundation Trust, and The Walton Centre NHS Foundation Trust.
Target population
Patients will be recruited from pain, spinal and musculoskeletal clinics at the three participating NHS centres and their associated community clinics. Patients will be referred by their general practitioners with low back pain requiring further specialist assessment, for reasons such as uncertain diagnosis, failure of conservative treatment, or expectation of therapeutic interventions. A screening visit will be used to identify eligible patients i.e. pain of at least 3 months' duration and an average pain intensity numerical rating score (NRS) of at least 4/10 in the 7 preceding days, signs and symptoms of facet-joint disease including bilateral localised paraspinal tenderness at 2 lumbar levels, and have received two components of NICE-defined best non-invasive care (education and one of: physical exercise programme, acupuncture, or manual therapy).
Health technologies being assessed
Facet-joint injections of local anaesthetic and steroid for non-specific low back pain. (Delivered in this study as four X-ray guided intra-articular facet-joint injections through a spinal needle at two lumbar levels bilaterally, using 0.5ml 0.5% bupivacaine + 20mg methylprednisolone per joint, under fluoroscopic guidance.)
Measurement of costs and outcomes
The primary outcomes for this feasibility study include: patient recruitment and attrition rates, levels of patient completion of outcomes, acceptability of the study design to patients and clinicians, fidelity of sham injection and process of blinding, and collection of variance outcome data to inform a future sample size calculation.
The investigators have proposed stopping rules for progression to a main trial. The proposed outcomes for the main trial have been selected in accord with IMMPACT recommendations for chronic pain trials and include: pain assessment, psychological well-being, health-related quality of life, functional disability, health care utilisation including analgesic usage, lost productivity and complications/level of adverse events. Outcomes will be collected at clinic visits at baseline (pre-randomisation) and at 6 weeks, 3 months, and 6 months post-randomisation.
Sample size
The investigators will recruit a total of 150 patients who will undergo a diagnostic facet-joint injection to determine eligibility to participate (test positive for facet-joint disease). Sixty participants (40% of all recruited) are expected to have a positive response to the diagnostic test; these 60 patients will be randomly and equally allocated to intervention and control groups. Assuming up to a 33% attrition rate, the investigators will have >24 complete data sets per arm at the end of the study. This sample size will allow us to achieve our various feasibility objectives.
Project timetables including recruitment rate
A retrospective audit of patient throughput in participating clinics shows that recruitment to achieve 30 patients per treatment arm is readily feasible in the time frame of this study. From 1000 new patient attendances for low back pain at the pain services, the investigators expect approximately 1 in 4 patients to be eligible to enter the study. This is based on our clinical experience and published studies based on responses to controlled diagnostic facet-joint injections, performed in accordance with the criteria established by the International Association for the Study of Pain. Of these 250 patients, approximately 60% (150) will consent to enter the study, of whom approximately 40% (60 patients) are expected to have a positive response from diagnostic medial branch nerve blocks.
The investigators anticipate that the project will take a total of 21 months to complete.
- Conditions
- Low Back Pain
- Being tested
- Active Procedure, Sham procedure
- Keywords
- low back pain, lumbar facet joint pain, feasibility, lumbar facet joint injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ProcedureProcedure or surgery
Also called Active group, 0.5% bupivacaine + 20mg methylprednisolone, Depo-medrone + Bupivacaine
If they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure.
Active: 4 X-ray guided intra-articular lumbar facet-joint injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml bupivacaine + 20mg methylprednisolone per joint
Sham procedureProcedure or surgery
Also called Sham group, 0.9% sodium chloride, normal saline, placebo
If they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure.
Sham: 4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 0.9% sodium chloride per joint.
| Study group | Role | What they receive |
|---|---|---|
| Active Procedure | Active comparator | All patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure.
4 X-ray guided intra-articular facet-joint injections via a spinal needle at 2 bilateral lumbar levels, using 0.5ml 0.5% bupivacaine + 20mg methylprednisolone per joint Receives: Procedure: Active Procedure |
| Sham procedure | Sham comparator | All patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure.
4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml normal saline per injection Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain numerical rating scale (NRS)
The rationale for carrying out diagnostic medial branch nerve blocks is because of their safety, simplicity and prognostic value.
There is currently no justification for double, comparative blocks as these are associated with a significant false-negative rate and are not shown to be cost-effective.
The pain scores at baseline (recruitment) will be recorded using a numerical rating scale (0-10) and will be compared to the score taken 20-40 minutes and 180-200 minutes after the injections. If a positive response of 50% pain reduction is seen, we know the pain is definately coming from the facet- joint which entitles the patient to be eligible for the randomised procedure.
Measured: Baseline (visit 1) and diagnostic injections (visit 2)
Secondary outcomes (14)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Pain assessments to assess change in outcome measure in the form of questionnaires.
Measured: Baseline (visit 1)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline visit.
Measured: 6 weeks (visit 4)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline visit.
Measured: 3 months (visit 5)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline visit.
Measured: 6 months (visit 6)
Expectation of benefit
0 to 6 scale, ranging from "expect no improvement" to "expect total improvement".
Measured: Baseline
Change in Health-related quality of life: EQ5D-5L, 12-item Short Form Survey (SF-12) at different follow- up visits
Pain assessments to assess change in outcome measure in the form of questionnaires.
Measured: Baseline (visit 1), 6 weeks (visit 4), 3 months (visit 5) and 6 months (visit 6)
Change in Functional impairment: Oswestry Low Back Pain Disability Questionnaire, Pain Self Efficacy Questionnaire (PSEQ) at different follow-up visits
Pain assessments to assess change in outcome measure in the form of questionnaires.
Measured: Baseline (visit 1)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.
Measured: 6 weeks (visit 4)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.
Measured: 3 months (visit 5)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.
Measured: 6 months (visit 6)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
This will include the use if published national costs to calculate costs of delivering each treatment arm/intervention and downstream healthcare utilization. The tools to assess this are the Stanford Presenteeism Scale 6, self-reported measures of sickness absence over the previous 3 months, and healthcare utilisation in the form of hospital visits, treatments and medications.
Measured: Baseline (visit 1)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
This will include the use if published national costs to calculate costs of delivering each treatment arm/intervention and downstream healthcare utilization. The tools to assess this are the Stanford Presenteeism Scale 6, self-reported measures of sickness absence over the previous 3 months, and healthcare utilisation in the form of hospital visits, treatments and medications.This will be compared with responses from the baseline visit.
Measured: 6 weeks (visit 4)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
This will include the use if published national costs to calculate costs of delivering each treatment arm/intervention and downstream healthcare utilization. The tools to assess this are the Stanford Presenteeism Scale 6, self-reported measures of sickness absence over the previous 3 months, and healthcare utilisation in the form of hospital visits, treatments and medications.This will be compared with responses from the baseline visit.
Measured: 3 months (visit 5)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
This will include the use if published national costs to calculate costs of delivering each treatment arm/intervention and downstream healthcare utilization. The tools to assess this are the Stanford Presenteeism Scale 6, self-reported measures of sickness absence over the previous 3 months, and healthcare utilisation in the form of hospital visits, treatments and medications.This will be compared with responses from the baseline visit.
Measured: 6 months (visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startJul 2015
- Primary completion31 Mar 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with persistent low back pain, referred to a community or hospital-based pain clinic by their general practitioner, will be reviewed and assessed by a pain physiotherapist and pain physician. They will be screened and recruited based on clinical history and examination. Participants will receive diagnostic injections (medial branch nerve blocks); those with a positive response will randomly receive either steroid FJIs or a sham procedure, under x-ray guidance.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Vivek Mehta, MBBS, Study director, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339362
- Sponsor's protocol ID
- Facet-joint feasibility study
- Acronym
- FACET
- Status last verified
- Jun 2017
- First submitted
- 1 Sep 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plans are made to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Double-blind Randomised Controlled Trial to Assess the Clinical- and Cost-effectiveness of Facet-joint Injections in Selected Patients With Non-specific Low Back Pain: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03339362
- Acronym / sponsor ID
- FACET / Facet-joint feasibility study
- Conditions
- Low Back Pain
- Keywords
- low back pain, lumbar facet joint pain, feasibility, lumbar facet joint injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 13 Nov 2017 (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.
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may cause persistent low back pain, with significant socioeconomic impact. At present, there is insufficient high quality evidence to support the use of lumbar facet-joint injections (FJIs) in treating low back pain of less than 12 months' duration; the National Institute for Health and Care Excellence (NICE) therefore did not approved their use in their 2009 publication.
This study will investigate the feasibility of conducting a larger, definitive trial to assess lumbar FJIs (a needle is inserted into the facet-joint and steroid injected), by comparing it to a dummy or 'sham' procedure (a needle is inserted near the facet-joint but no therapeutic substance injected).
Patients with persistent low back pain, referred to a community or hospital-based pain, spinal or musculoskeletal clinic by their general practitioner, will be reviewed and assessed by a specialist physician. They will be screened and recruited based on clinical history and examination. Participants will receive diagnostic injections (medial branch nerve blocks); those with a positive response will randomly receive either FJIs or a sham procedure, under x-ray guidance. All participants will receive a combined physical and psychological programme recommended by NICE as a strategy to reduce pain and its impact on the person's day-to-day life, even if the pain cannot be cured completely.
Participants will be asked to complete questionnaires comparing a range of pain and disability-related issues. These will occur at baseline (before treatment) and at 6 weeks, 3 months and 6 months after their injections.
Criteria for the study to be considered successful (and a definitive trial feasible) include the abilities to standardise the methods for injection and to recruit and retain sufficient participants, and the acceptability of the study design to participants and clinicians.
Detailed description
Design
This study seeks to examine the feasibility of undertaking a fully powered double-blind randomised controlled trial. Patients with non-specific low back pain of more than three months' duration with confirmed facet-joint disease will be individually randomised 1:1 to receive facet-joint injections plus a combined physical and psychological programme (intervention group) or to a sham (placebo) procedure plus a combined physical and psychological programme (control group).
Setting
The feasibility study will be conducted in three hospital-based pain medicine centres: Barts Health NHS Trust (formerly Barts and The London NHS Trust), Basildon and Thurrock University Hospitals NHS Foundation Trust, and The Walton Centre NHS Foundation Trust.
Target population
Patients will be recruited from pain, spinal and musculoskeletal clinics at the three participating NHS centres and their associated community clinics. Patients will be referred by their general practitioners with low back pain requiring further specialist assessment, for reasons such as uncertain diagnosis, failure of conservative treatment, or expectation of therapeutic interventions. A screening visit will be used to identify eligible patients i.e. pain of at least 3 months' duration and an average pain intensity numerical rating score (NRS) of at least 4/10 in the 7 preceding days, signs and symptoms of facet-joint disease including bilateral localised paraspinal tenderness at 2 lumbar levels, and have received two components of NICE-defined best non-invasive care (education and one of: physical exercise programme, acupuncture, or manual therapy).
Health technologies being assessed
Facet-joint injections of local anaesthetic and steroid for non-specific low back pain. (Delivered in this study as four X-ray guided intra-articular facet-joint injections through a spinal needle at two lumbar levels bilaterally, using 0.5ml 0.5% bupivacaine + 20mg methylprednisolone per joint, under fluoroscopic guidance.)
Measurement of costs and outcomes
The primary outcomes for this feasibility study include: patient recruitment and attrition rates, levels of patient completion of outcomes, acceptability of the study design to patients and clinicians, fidelity of sham injection and process of blinding, and collection of variance outcome data to inform a future sample size calculation.
The investigators have proposed stopping rules for progression to a main trial. The proposed outcomes for the main trial have been selected in accord with IMMPACT recommendations for chronic pain trials and include: pain assessment, psychological well-being, health-related quality of life, functional disability, health care utilisation including analgesic usage, lost productivity and complications/level of adverse events. Outcomes will be collected at clinic visits at baseline (pre-randomisation) and at 6 weeks, 3 months, and 6 months post-randomisation.
Sample size
The investigators will recruit a total of 150 patients who will undergo a diagnostic facet-joint injection to determine eligibility to participate (test positive for facet-joint disease). Sixty participants (40% of all recruited) are expected to have a positive response to the diagnostic test; these 60 patients will be randomly and equally allocated to intervention and control groups. Assuming up to a 33% attrition rate, the investigators will have >24 complete data sets per arm at the end of the study. This sample size will allow us to achieve our various feasibility objectives.
Project timetables including recruitment rate
A retrospective audit of patient throughput in participating clinics shows that recruitment to achieve 30 patients per treatment arm is readily feasible in the time frame of this study. From 1000 new patient attendances for low back pain at the pain services, the investigators expect approximately 1 in 4 patients to be eligible to enter the study. This is based on our clinical experience and published studies based on responses to controlled diagnostic facet-joint injections, performed in accordance with the criteria established by the International Association for the Study of Pain. Of these 250 patients, approximately 60% (150) will consent to enter the study, of whom approximately 40% (60 patients) are expected to have a positive response from diagnostic medial branch nerve blocks.
The investigators anticipate that the project will take a total of 21 months to complete.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with persistent low back pain, referred to a community or hospital-based pain clinic by their general practitioner, will be reviewed and assessed by a pain physiotherapist and pain physician. They will be screened and recruited based on clinical history and examination. Participants will receive diagnostic injections (medial branch nerve blocks); those with a positive response will randomly receive either steroid FJIs or a sham procedure, under x-ray guidance.
| Arm | Type | Receives |
|---|---|---|
| Active Procedure | Active comparator | Procedure: Active ProcedureAll patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure. 4 X-ray guided intra-articular facet-joint injections via a spinal needle at 2 bilateral lumbar levels, using 0.5ml 0.5% bupivacaine + 20mg methylprednisolone per joint |
| Sham procedure | Sham comparator | Procedure: Sham procedureAll patients will receive 6 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 1% Lidocaine. This a test procedure to identify the patient has a 50% pain reduction from baseline pain numerical score. If patients pass this test injection, they will be randomised to the active or sham procedure. 4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml normal saline per injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
- Low back pain of greater than three months' duration.
- Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
- Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
- At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture, and manual therapy.
Key exclusion criteria (19 listed)
- Patient refusal.
- More than four painful lumbar facet-joints.
- Patient has not completed at least two components of NICE-recommended best non-invasive care.
- 'Red flag' signs ('Red flag' signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
- Hypersensitivity to study medications or X-ray contrast medium.
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 |
|---|---|---|
| Active ProcedureAlso: Active group, 0.5% bupivacaine + 20mg methylprednisolone, Depo-medrone + BupivacaineIf they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure. Active: 4 X-ray guided intra-articular lumbar facet-joint injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml bupivacaine + 20mg methylprednisolone per joint | Procedure or surgery | Active Procedure |
| Sham procedureAlso: Sham group, 0.9% sodium chloride, normal saline, placeboIf they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure. Sham: 4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 0.9% sodium chloride per joint. | Procedure or surgery | Sham procedure |
Primary outcome
Change in Pain numerical rating scale (NRS)
Time frame: Baseline (visit 1) and diagnostic injections (visit 2)
The rationale for carrying out diagnostic medial branch nerve blocks is because of their safety, simplicity and prognostic value. There is currently no justification for double, comparative blocks as these are associated with a significant false-negative rate and are not shown to be cost-effective. The pain scores at baseline (recruitment) will be recorded using a numerical rating scale (0-10) and will be compared to the score taken 20-40 minutes and 180-200 minutes after the injections. If a positive response of 50% pain reduction is seen, we know the pain is definately coming from the facet- joint which entitles the patient to be eligible for the randomised procedure.
14 secondary outcomes
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Time frame: Baseline (visit 1)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Time frame: 6 weeks (visit 4)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Time frame: 3 months (visit 5)
Change in Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire.
Time frame: 6 months (visit 6)
Expectation of benefit
Time frame: Baseline
Change in Health-related quality of life: EQ5D-5L, 12-item Short Form Survey (SF-12) at different follow- up visits
Time frame: Baseline (visit 1), 6 weeks (visit 4), 3 months (visit 5) and 6 months (visit 6)
Change in Functional impairment: Oswestry Low Back Pain Disability Questionnaire, Pain Self Efficacy Questionnaire (PSEQ) at different follow-up visits
Time frame: Baseline (visit 1)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Time frame: 6 weeks (visit 4)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Time frame: 3 months (visit 5)
Change in Co-psychological well-being: Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, SF-12, BPI at different follow up visits
Time frame: 6 months (visit 6)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
Time frame: Baseline (visit 1)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
Time frame: 6 weeks (visit 4)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
Time frame: 3 months (visit 5)
Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits
Time frame: 6 months (visit 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No. No plans are made to share individual participant data
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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.
Vivek Mehta, MBBS study director
Barts & The London NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active Procedure in people with Low Back Pain, run by Barts & The London NHS Trust at 3 sites in United Kingdom.
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 19 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: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain numerical rating scale (NRS) (time frame: Baseline (visit 1) and diagnostic injections (visit 2)). 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 13 Nov 2017.