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FAcet-joint Injection Clinical and Cost-effective Trial (FACET)

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ClinicalTrials.gov Identifier: NCT03339362
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Active Procedure Procedure: Sham procedure Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active Procedure

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

Procedure: Active Procedure

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

Other Names:
  • Active group
  • 0.5% bupivacaine + 20mg methylprednisolone
  • Depo-medrone + Bupivacaine
Sham Comparator: Sham procedure

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

Procedure: Sham procedure

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.

Other Names:
  • Sham group
  • 0.9% sodium chloride
  • normal saline
  • placebo



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  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: Baseline (visit 1) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.

  2. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline visit.

  3. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline 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: 6 months (visit 6) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires. This will be compared with responses from the baseline visit.

  5. Expectation of benefit [ Time Frame: Baseline ]
    0 to 6 scale, ranging from "expect no improvement" to "expect total improvement".

  6. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.

  7. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.

  8. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.

  9. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.

  10. 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) ]
    Pain assessments to assess change in outcome measure in the form of questionnaires.This will be compared with responses from the baseline visit.

  11. Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits [ Time Frame: Baseline (visit 1) ]
    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.

  12. Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits [ Time Frame: 6 weeks (visit 4) ]
    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.

  13. Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits [ Time Frame: 3 months (visit 5) ]
    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.

  14. Change in Healthcare utilisation and costs, and impact on productivity at different follow up visits [ Time Frame: 6 months (visit 6) ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Low back pain of greater than three months' duration.
  3. 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).
  4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
  5. 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.

Exclusion Criteria:

  1. Patient refusal.
  2. More than four painful lumbar facet-joints.
  3. Patient has not completed at least two components of NICE-recommended best non-invasive care.
  4. '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).
  5. Hypersensitivity to study medications or X-ray contrast medium.
  6. 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).
  7. Dominantly midline tenderness over the lumbar spine.
  8. Any other dominant pain.
  9. Any major systemic disease or mental health illness that may affect the patient's pain, disability and/or their ability to exercise and rehabilitate.
  10. Any active neoplastic disease, including primary or secondary neoplasm.
  11. Pregnant or breastfeeding patients.
  12. Previous lumbar facet-joint injections.
  13. Previous lumbar spinal surgery.
  14. Patients with morbid obesity (body mass index of 35 or greater).
  15. Major trauma or infection to the lumbar spine.
  16. Participation in another clinical trial in the past thirty days.
  17. Patients unable to commit to the six-month study duration.
  18. Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
  19. Patients with a history of substance abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339362


Locations
United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, United Kingdom, SS16 5NL
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom, L9 7LJ
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust
National Institute for Health Research, United Kingdom
Investigators
Study Director: Vivek Mehta, MBBS Barts & The London NHS Trust

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03339362     History of Changes
Other Study ID Numbers: Facet-joint feasibility study
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans are made to share individual participant data

Keywords provided by Barts & The London NHS Trust:
low back pain
lumbar facet joint pain
feasibility
lumbar facet joint injection

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Methylprednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal