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Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.

ABSTRACT: BACKGROUND:The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin. METHODS/DESIGN:We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n?=?150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n?=?75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders. DISCUSSION:Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain. TRIAL REGISTRATION:EudraCT identifier 2014-000682-50, (registered on 12 February 14). ISRCTN registry number: ISRCTN93184143 DOI 10.1186/ISRCTN93184143 (registered on 27 February 2014).

SUBMITTER: Sandhu H

PROVIDER: S-EPMC4690389 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.

Sandhu Harbinder H Ellard David R DR Achana Felix F Antrobus James H L JH Balasubramanian Shyam S Brown Sally S Cairns Melinda M Griffiths Frances F Haywood Kirstie K Hutchinson Charles C Lall Ranjit R Petrou Stavros S Stallard Nigel N Tysall Colin C Walsh David A DA Underwood Martin M

Trials 20151224

<h4>Background</h4>The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin.<h4>Meth ...[more]

PMID: 26703477

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Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

Project description:Clinical practice guidelines state that the tissue source of low back pain cannot be specified in the majority of patients. However, there has been no systematic review of the accuracy of diagnostic tests used to identify the source of low back pain. The aim of this systematic review was therefore to determine the diagnostic accuracy of tests available to clinicians to identify the disc, facet joint or sacroiliac joint (SIJ) as the source of low back pain. MEDLINE, EMBASE and CINAHL were searched up to February 2006 with citation tracking of eligible studies. Eligible studies compared index tests with an appropriate reference test (discography, facet joint or SIJ blocks or medial branch blocks) in patients with low back pain. Positive likelihood ratios (+LR) > 2 or negative likelihood ratios (-LR) < 0.5 were considered informative. Forty-one studies of moderate quality were included; 28 investigated the disc, 8 the facet joint and 7 the SIJ. Various features observed on MRI (high intensity zone, endplate changes and disc degeneration) produced informative +LR (> 2) in the majority of studies increasing the probability of the disc being the low back pain source. However, heterogeneity of the data prevented pooling. +LR ranged from 1.5 to 5.9, 1.6 to 4.0, and 0.6 to 5.9 for high intensity zone, disc degeneration and endplate changes, respectively. Centralisation was the only clinical feature found to increase the likelihood of the disc as the source of pain: +LR = 2.8 (95%CI 1.4-5.3). Absence of degeneration on MRI was the only test found to reduce the likelihood of the disc as the source of pain: -LR = 0.21 (95%CI 0.12-0.35). While single manual tests of the SIJ were uninformative, their use in combination was informative with +LR of 3.2 (95%CI 2.3-4.4) and -LR of 0.29 (95%CI 0.12-0.35). None of the tests for facet joint pain were found to be informative. The results of this review demonstrate that tests do exist that change the probability of the disc or SIJ (but not the facet joint) as the source of low back pain. However, the changes in probability are usually small and at best moderate. The usefulness of these tests in clinical practice, particularly for guiding treatment selection, remains unclear.

Dataset Information

Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.

Publications

Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.

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