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

Completed

• Conditions: ow back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN12191542
• Lead Sponsor: IHR Health Technology Assessment Programme - HTA (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29231159

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-03
• Study Completion: 2017-03-31
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams<br>2. To assess the feasibility of the proposed definitive trial design including:<br>2.1. Testing of randomisation and blinding procedures<br>2.2. Development of an appropriate active and sham procedure for FJIs<br>2.3. Assessment of the consistency of the trial sites to deliver the combined physical and psychological programme<br>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)<br>3. To estimate outcome standard deviation to inform the power calculation for a definitive trial<br>4. To finalise the protocol design, statistical plan, number of centres required and study duration of the definitive trial