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Spine

A MULTICENTRE DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL TO ASSESS THE CLINICAL EFFECTIVENESS AND COST EFFECTIVENESS OF FACET-JOINT INJECTIONS IN SELECTED PATIENTS WITH NON-SPECIFIC LOW BACK PAIN: A FEASIBILITY STUDY

The Society for Back Pain Research (SBPR), Northampton, England, November 2017



Abstract

Purposes of the study and background

Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain.

The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure.

Summary of methods and results

This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion.

Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme.

Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed.

Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study.

Conclusions

Due to the small numbers of participants recruited to the study, we were unable to draw any conclusions on the effectiveness of intra-articular lumbar facet-joint injections in the management of non-specific low back pain. We however demonstrated our ability to develop a robust study protocol and deliver the intended interventions safely, thus addressing many of the feasibility objectives.

Stronger collaborations with primary care may improve the recruitment of patients earlier in their pain trajectory, suitable for inclusion in a future trial.

Conflicts of interest: None

Sources of funding: National Institute for Health Research Health Technology Assessment programme grant (reference number 11/31/02)


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