FAcet-joint Injection Clinical and Cost-effective 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. 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

Interventions

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

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.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Barts & The London NHS Trust

  lead OTHER

Principal Investigators

• Vivek Mehta, MBBS · Barts & The London NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2017-03-31

Completion

2017-05-15

Countries

• United Kingdom

Study Locations