FAcet-joint Injection Clinical and Cost-effective Trial

NCT03339362 | Completed Phase 4 DMC

• 1 other identifier: Facet-joint feasibility study
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Keywords

low back pain; lumbar facet joint pain; feasibility; lumbar facet joint injection

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  6 months (visit 6)

• Expectation of benefit

  Baseline

Study Arms (2)

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

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

Procedure: Sham procedure

Interventions

Active Procedure 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

Also known as: Active group, 0.5% bupivacaine + 20mg methylprednisolone, Depo-medrone + Bupivacaine

Active Procedure

Sham procedure 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.

Also known as: Sham group, 0.9% sodium chloride, normal saline, placebo

Sham procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (3)

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, Essex, SS16 5NL, United Kingdom

Location

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Bupivacaine; Methylprednisolone; Methylprednisolone Acetate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vivek Mehta, MBBS

  Barts & The London NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: November 13, 2017
• Study Start: July 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: May 15, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)