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Clinical Trials/ISRCTN12191542
ISRCTN12191542
Completed
Not Applicable

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

IHR Health Technology Assessment Programme - HTA (UK)0 sites150 target enrollmentJanuary 3, 2014
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Conditionsow back painMusculoskeletal DiseasesLow back pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ow back pain
Sponsor
IHR Health Technology Assessment Programme - HTA (UK)
Enrollment
150
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
January 3, 2014
End Date
March 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
IHR Health Technology Assessment Programme - HTA (UK)

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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