TY - JOUR
T1 - Facet-joint injections for people with persistent non-specific low back pain (FIS)
T2 - Study protocol for a randomised controlled feasibility trial
AU - Sandhu, Harbinder
AU - Ellard, David R.
AU - Achana, Felix
AU - Antrobus, James H.L.
AU - Balasubramanian, Shyam
AU - Brown, Sally
AU - Cairns, Melinda
AU - Griffiths, Frances
AU - Haywood, Kirstie
AU - Hutchinson, Charles
AU - Lall, Ranjit
AU - Petrou, Stavros
AU - Stallard, Nigel
AU - Tysall, Colin
AU - Walsh, David A.
AU - Underwood, Martin
N1 - Funding Information:
MU was chair of the NICE back pain development group that produced the 2009 guidelines and DAW was a member of that Guideline Development Group. DAW is a member of the NICE Low Back Pain and Sciatica Guideline Development Group expected to produce updated guidance in 2016. MU, HS, JA, SBa, SBr, MC, FG, KH, CH, SP, NS, CT, and DW are all co-applicants on the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) project funded here and as have received funding for their roles. DE was part funded as a researcher from the same grant. RL and FA report no competing interests.
Publisher Copyright:
© 2015 Sandhu et al.
PY - 2015/12/24
Y1 - 2015/12/24
N2 - 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: ISRCTN93184143DOI 10.1186/ISRCTN93184143(registered on 27 February 2014).
AB - 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: ISRCTN93184143DOI 10.1186/ISRCTN93184143(registered on 27 February 2014).
KW - Combined physical and psychological programme
KW - Corticosteroids
KW - Intra-articular facet joint injections
KW - Low back pain
UR - http://www.scopus.com/inward/record.url?scp=84951813354&partnerID=8YFLogxK
U2 - 10.1186/s13063-015-1117-z
DO - 10.1186/s13063-015-1117-z
M3 - Article
C2 - 26703477
AN - SCOPUS:84951813354
SN - 1745-6215
VL - 16
JO - Trials
JF - Trials
IS - 1
M1 - 588
ER -