Status:
COMPLETED
FAcet-joint Injection Clinical and Cost-effective Trial
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Lumbar facet-joints are small, paired joints in the low back that provide stability, integrity and flexibility of movement to the spine. Diseased facet-joints may cause persistent low back pain, with ...
Detailed Description
Design This study seeks to examine the feasibility of undertaking a fully powered double-blind randomised controlled trial. Patients with non-specific low back pain of more than three months' duratio...
Eligibility Criteria
Inclusion
- Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
- Low back pain of greater than three months' duration.
- Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
- Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
- 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
- Patient refusal.
- More than four painful lumbar facet-joints.
- Patient has not completed at least two components of NICE-recommended best non-invasive care.
- 'Red flag' signs ('Red flag' signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
- Hypersensitivity to study medications or X-ray contrast medium.
- Radicular pain (Radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band).
- Dominantly midline tenderness over the lumbar spine.
- Any other dominant pain.
- Any major systemic disease or mental health illness that may affect the patient's pain, disability and/or their ability to exercise and rehabilitate.
- Any active neoplastic disease, including primary or secondary neoplasm.
- Pregnant or breastfeeding patients.
- Previous lumbar facet-joint injections.
- Previous lumbar spinal surgery.
- Patients with morbid obesity (body mass index of 35 or greater).
- Major trauma or infection to the lumbar spine.
- Participation in another clinical trial in the past thirty days.
- Patients unable to commit to the six-month study duration.
- Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
- Patients with a history of substance abuse.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03339362
Start Date
July 1 2015
End Date
May 15 2017
Last Update
November 13 2017
Active Locations (3)
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1
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, United Kingdom, SS16 5NL
2
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom, L9 7LJ
3
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE