Assessing the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain

• Register: ISRCTN
• Last refreshed on: 19 March 2018
• Main ID: ISRCTN12191542
• Date of registration: 03/01/2014
• Prospective Registration: Yes
• Primary sponsor: NIHR Health Technology Assessment Programme - HTA (UK)
• Public title: Assessing the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain
• Scientific title: A multicentre double-blind randomised controlled trial to assess the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain: a feasibility study
• Date of first enrolment: 01/04/2014
• Target sample size: 150
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12191542
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Richard Langford

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of nonspecific low back pain
2. Low back pain of greater than three months? duration
3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment
4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels
5. At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture and manual therapy
Exclusion criteria: 1. Patient refusal
2. More than four painful lumbar facet-joints
3. Patient has not completed at least two components of NICE-recommended best non-invasive care
4. 'Red flag' signs
5. Hypersensitivity to study medications or X-ray contrast medium
6. Radicular pain
7. Dominantly midline tenderness over the lumbar spine
8. Any other dominant pain
9. Any major systemic disease or mental health illness that may affect the patient?s pain, disability and/or their ability to exercise and rehabilitate
10. Any active neoplastic disease, including primary or secondary neoplasm
11. Pregnant or breastfeeding patients
12. Previous lumbar facet-joint injections
13. Previous lumbar spinal surgery
14. Patients with morbid obesity (body mass index of 35 or greater)
15. Major trauma or infection to the lumbar spine
16. Participation in another clinical trial in the past 30 days
17. Patients unable to commit to the six-month study duration
18. Patients involved in legal actions or employment tribunals related to their low back pain
19. Patients with a history of substance abuse

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Low back pain
Musculoskeletal Diseases
Low back pain

Intervention(s)

Patients will be recruited from pain clinics at the three participating NHS centres and their associated community-based pain clinics. Patients will be referred by their general practitioners with low back pain requiring further specialist assessment, for reasons such as uncertain diagnosis, failure of conservative treatment or expectation of therapeutic interventions. We will recruit a total of 150 patients, of whom 60 (40%) are expected to have a positive diagnostic test for facet-joint disease, and these 60 patients will be randomly and equally allocated to receive one of the following two interventions:

1. Facet-joint injections of local anaesthetic and steroid plus a combined physiotherapy and psychology (CPP) programme
2. A sham (placebo) procedure plus a CPP programme

FJIs, the sham procedures and diagnostic tests will be performed in day surgery units at each of the three main centres. They will be carried out only by appropriately qualified members of the research team (Fellows of the Faculty of Pain Medicine of the Royal College of Anaesthetists), adhering to strict aseptic conditions and following local theatre protocols with regards to admission and discharge criteria.

Primary Outcome(s)

To assess the eligibility criteria, recruitment and retention of patients in the two treatment arms (FJI versus sham procedure)

Secondary Outcome(s)

1. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams
2. To assess the feasibility of the proposed definitive trial design including:
2.1. Testing of randomisation and blinding procedures
2.2. Development of an appropriate active and sham procedure for FJIs
2.3. Assessment of the consistency of the trial sites to deliver the combined physical and psychological programme
2.4. Ability to collect the outcomes proposed for the main trial (pain, functioning, health-related quality of life, anxiety and depression, healthcare resource utilisation, complications and adverse events)
3. To estimate outcome standard deviation to inform the power calculation for a definitive trial
4. To finalise the protocol design, statistical plan, number of centres required and study duration of the definitive trial

Secondary ID(s)

PARC_HTA_11/31/02

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

The study will be reviewed by a Research Ethics Committee, to ensure that the rights, safety, dignity and well-being of study participants are protected. A copy of the proposed informed consent form will be reviewed with the study protocol. The NETSCC will be informed once a specific NRES committee has been appointed. We will apply for ethical review through the centralised National Research Ethics Service (NRES) system and commence work on the application on approval of an agreed protocol and a

Results

• Results available: Yes
• Date Completed: 31/03/2017