Muscoskeletal, low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
Participants will be randomised to receive either facet joint injection with best usual care, or best usual care only.
Pain outcomes will be collected immediately before and after injection (interv
all injections should take place within 21 days of randomisation), then weekly for three months post-intervention. Health utility data (EQ-5D-5L) will be collected daily for eight days around the noti
Sponsors
University Hospitals Coventry & Warwickshire NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/09/2014: 1. The patient is willing to comply with the trial procedures and signed and dated informed consent is obtained 2. The patient is aged >18 with at least moderately troublesome low back pain present for at least six months 3. The patient reports low back pain as their predominant musculoskeletal pain 4. The patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion 5. The patient meets clinical criteria for possible facet joint pain when there is no radicular symptoms (defined as pain radiating below the knee) and no sacro-iliac joint pain elicited using a pain provocation test and increased pain unilaterally, bilaterally on lumbar para-spinal palpation, and increased low back pain on one or more of the following: extension (more than flexion), rotation, extension/side flexion, extension/rotation 6. The patient is able to manage text messaging, or an alternative means of daily data collection (paper-based diary) 7. The patient is fluent in written and spoken English Previous inclusion criteria: 1.The patient is able and willing to comply with the trial procedures and signed and dated informed consent is obtained 2.The patient is >18 with at least moderately troublesome low back pain present for at least six months 3.The patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion 4.The patient meets clinical criteria for possible facet joint pain 5.The patient is able to manage text messaging, or an alternative means of daily data collection (paper based diary) 6.The patient is fluent in written and spoken English
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/09/2014: 1. The patient is unable to attend for randomised treatment, or other circumstances that would significantly decrease the chance of obtaining reliable data, achieving trial objectives or completing the trial and follow-up assessments or is considered unsuitable to participate in the trial by an investigator 2. The patient is unable/unwilling to undergo injections 3. The patient has used oral corticosteroids or had a corticosteroid injection in the preceding three months. 4. The patient is has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention 5. The patient has previously undergone spinal injections 6. The patient is has previously undergone spinal surgery 7. The patient has a contraindication to facet joint injections; for example, a serious co-morbidity (e.g., severe COPD, poorly controlled diabetes), malignancy, infection, inflammatory disorder, or fracture; or is taking anti-coagulant medication 8. The patient has a known allergy to the constituents of the planned injections 9. The patient is pregnant, or suspected pregnancy 10. The patient was previously randomised in this trial 11. The patient is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial Previous exclusion criteria: 1.The patient is unable to attend for randomised treatment, or other circumstances that would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study and follow up assessments or is considered unsuitable to participate in the study by an investigator. 2.The patient is unable/unwilling to undergo injections. 3.The patient has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention. 4.The patient has a contraindication to facet joint injections (eg, serious co-morbidity, previous spinal surgery, or taking anti-coagulants). 5.The patient has a known allergy to the constituents of the planned injections. 6.The patient is pregnant or breast feeding. 7.The patient was previously randomised in this trial. 8.The patient is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this feasibility study is numerical rating scale for pain collected over three months following randomisation. A package of outcome measures consistent with consensus recommendations for outcome assessment in back pain trials will be utilised. These include pain measurement, physical function, emotional function, back-related function, generic well-being, disability (social role), and satisfaction with care, patient rating of improvement and satisfaction with treatment, symptoms (pain), adverse events, participant disposition, and a modified form of the patient generated index. In this feasibility study we will assess performance of these measures and seek to reduce the questionnaire burden in the main trial. The main questionnaire packages are completed at baseline (at study entry assessment) and follow-up (3, 6 and 12 months post randomisation). A pain severity score will be recorded daily for 35 days from seven days before first treatment session and following this weekly until the end of the study. Health utility (EQ-5D-5L) will be recorded weekly from one week prior to the first treatment session until the night before the injection appointment when we will ask participants to record it daily for eight days then weekly until the end of the study. In addition, intervention participants will record a pain severity 45-60 minutes before and after injection. Clinical data will recorded by the physiotherapists and the clinician and collected covering patients assessments, injections and involvement in the physiotherapy intervention. Note it may be necessary to increase the number of data points for the EQ-5D-5L and the pain severity score; firstly, if an injection is cancelled/rescheduled and secondly, towards the end to ensure test-retest reliability. To reduce costs and shorten time to completion of the feasibility study we will do a single cycle of postal follow-up with two postal reminders and a telephone call for primary outcomes at | — |
Secondary
| Measure | Time frame |
|---|---|
| As a second primary outcome focused on back pain related disability we will use the Roland Morris Disability Questionnaire at three months, six and 12 months collected using a postal questionnaire | — |
Countries
United Kingdom
Outcome results
None listed