RFN for SIJ Disease Study

This study is currently recruiting participants.
Verified January 2013 by Barts & The London NHS Trust
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01726608
First received: November 11, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of the study is to investigate if a technique called Simplicity III® Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain. Currently there are a variety of treatments for managing this pain but there is still some doubt as to which treatments are the most effective. Simplicity III® is one such treatment for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical current to generate heat around the tip of the needle placed close to the nerves that supply the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves pain.

The traditional method used to treat this type of pain uses multiple injections to target the nerves supplying the joint. This method is however both time consuming and the results are variable depending upon the number of injections. Therefore a new electrode, called the Simplicity III®, was developed to allow the treatment to be undertaken using fewer injections. Although this treatment has received formal approval, undergone conformity assessment and is available in certain specialist NHS centres for clinical use, there is presently limited evidence with regards to its clinical efficacy. We wish to test the effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the clinical effectiveness is to compare Simplicity III® against an identical procedure where the electrode is not switched on and neither the patient nor the doctor is aware whether it was switched on. Once pain has been assessed at 3 months, those patients not receiving active treatment and remaining in pain will be offered the active treatment.


Condition Intervention Phase
Sacro Iliac Joint Pain
Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain Intensity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Short Form Mcgill Pain Questionnaire

  • Health related Quality of life [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Short form health survey

  • Anxiety and Depression [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Hospital and Depression Scale

  • Functional Disability [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Oswestry Low Back Pain Disability Questionnaire

  • Health related quality of life and quality-adjusted life years [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Euro Quol EQ-5D scale

  • Portion of patients randomised to sham requiring rescue therapy with RFN [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiofrequency neurotomy
Active Radiofrequency Neurotomy
Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III
Placebo Comparator: Sham
Sham radiofrequency neurotomy
Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written, informed consent
  2. Age: 18 - 80 years old
  3. Low back pain of more than 6 months duration with a minimum pain intensity of greater than 5 out of 10 on an 11-point numerical rating scale in the 7 days preceding study entry.
  4. Subjects must achieve greater than 80% reduction in pain following each diagnostic, intra-articular block. Subjects must undergo 2 blocks in total prior to randomisation.
  5. Female subjects of potential childbearing age must be using adequate contraception (i.e. using oral or intramuscular contraception or an IUCD) and must have a negative urine test.
  6. No vulnerable patient groups shall be recruited into this study

Exclusion Criteria:

  1. Subjects who do not fulfill inclusion criteria
  2. Subjects who have previously been treated by any sacroiliac joint radiofrequency neurotomy
  3. Subjects who are breastfeeding
  4. Contraindications to local anaesthetics and radiofrequency neurotomy as listed in their respective summary of product characteristics
  5. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality
  6. Subjects to whom any of the following apply: Major trauma to the lumbar spine in the six months preceding study entry. Infection in the lumbar spine in the six months preceding study entry
  7. Subjects' known to have a condition that, in the investigator's judgment precludes entry into the study.
  8. Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication.
  9. Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
  10. Subjects unable to comply with the study assessments or unable to complete the questionnaires.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726608

Contacts
Contact: Vivek Mehta, MD FRCA +442034655361 vivek.mehta@bartshealth.nhs.uk
Contact: Sibtain Anwar, MA MB FRCA +442034655361 sibtain.anwar@bartshealth.nhs.uk

Locations
United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Vivek Mehta, MD FRCA Barts & The London NHS Trust
Study Director: Sibtain Anwar, MA MB FRCA Barts & The London NHS Trust
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01726608     History of Changes
Other Study ID Numbers: Reda 7869
Study First Received: November 11, 2012
Last Updated: January 28, 2013
Health Authority: United Kingdom: National Research Ethics Service

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014