A randomised double blind placebo controlled trial of radiofrequency neurotomy for the treatment of lumbar zygapophysial joint pai

Not Applicable

Recruiting

• Conditions: umbar zygapophysial joint pain; Lumbar zygapophysial joint pain; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12608000365369
• Lead Sponsor: Dr. Paul Verrills

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Low back pain for a duration of more than 3 months
2. Pain severity of at least 5/10 on a visual analogue scale, which is sufficient to warrant invasive treatment
3. Complete, or vitually complete, relief of pain in response to controlled, medial branch blocks performed on at least two occasions.
4. Up to, but not exceeding two sympathetic zygapophysial joints per side

Exclusion Criteria

1. Unable to provide informed consent
2. Unable to complete the assessment instruments
3. Anatomical abnormalities that might interfere with the safe conduct of the treatment
4. Any illness or disorder that might interfere with the safe conduct of treatment
5. Overt, clinically evident psychological disturbance, such as severe depression, drug dependence, or drug-seeking behaviour that might interfere with the assessment or response to treatment
6. Concomitant cervical, thoracic, hip, or other pain, of an intensity greater than 2/10 (on the visual analogue scale (VAS))or otherwise, which may interfere with the assessment or response to treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective is to determine the efficacy of lumbar medial branch neurotomy, for proven lumbar zygapophysial joint pain. The primary outcome measure will be relief of pain. This will be done by self-assessment using a numerical pain rating scale and by doctor assessments at the follow up visits.[A pre-treatment assessment will be made, whilst follow up assessments will be scheduled at 3, 6, 9 and 12 months following treatment.]

Secondary Outcome Measures

Name	Time	Method
Comparison between pre treatment and post treatment disability and depression scores. These outcome measures will be measured by patient and doctor answered questionnaires. These questionnaires will consist of the Quality of Life (AQoL), SF-36, Roland-Morris diability scale and the patient-specified functional outcome measure questionnaire.[A pre-treatment assessment will be made, whilst follow up assessments will be scheduled at 3, 6, 9 and 12 months following treatment.]