A feasibility study investigating the clinical effectiveness and cost effectiveness of facet joint injections for low back pain against best usual care.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

Patients may be included in the trial if they meet all of the following 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's low back pain is 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients must be excluded from participating in this trial if they meet any of the following 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 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 corticosteroids or had a corticosteroid injection in the preceding three months.
4. The patient 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 has previously undergone spinal surgery
7. The patient has a contraindication to facet joint injections for example a serious co-morbidity (eg severe COPD, poorly controlled diabetes) malignancy, infection, inflammatory disorder, or fracture or is taking anti-coagulant medications.
8. The patient has a known allergy to the constituents of the planned injections.
9. Pregnancy. We will follow Royal College of Radiologists Guidance on radiation and the early fetus. (http://www.rcr.ac.uk/docs/radiology/pdf/BFCR(13)4_radiation.pdf) We will ask women of child bearing potential if they might be pregnant when they are assessed for study assessment. For those randomised to injections we will follow local policy for assessing any risk to an early fetus before exposure to radiation. Where appropriate we will arrange to schedule injections within ten days of the onset of menstruation.
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.