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RFN for SIJ Disease Study

Primary Purpose

Sacro Iliac Joint Pain

Status

Unknown status

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Comparison of active versus sham radiofrequency neurotomy with Simplicity III

About this trial

This is an interventional treatment trial for Sacro Iliac Joint Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written, informed consent
Age: 18 - 80 years old
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.
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.
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.
No vulnerable patient groups shall be recruited into this study

Exclusion Criteria:

Subjects who do not fulfill inclusion criteria
Subjects who have previously been treated by any sacroiliac joint radiofrequency neurotomy
Subjects who are breastfeeding
Contraindications to local anaesthetics and radiofrequency neurotomy as listed in their respective summary of product characteristics
Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality
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
Subjects' known to have a condition that, in the investigator's judgment precludes entry into the study.
Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication.
Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
Subjects unable to comply with the study assessments or unable to complete the questionnaires.

Sites / Locations

Barts Health NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Radiofrequency neurotomy

Sham

Arm Description

Active Radiofrequency Neurotomy

Sham radiofrequency neurotomy

Outcomes

Primary Outcome Measures

Pain Intensity

Secondary Outcome Measures

Pain Intensity

Quality of pain

Short Form Mcgill Pain Questionnaire

Health related Quality of life

Short form health survey

Anxiety and Depression

Hospital and Depression Scale

Functional Disability

Oswestry Low Back Pain Disability Questionnaire

Health related quality of life and quality-adjusted life years

Euro Quol EQ-5D scale

Portion of patients randomised to sham requiring rescue therapy with RFN

Full Information

NCT ID

NCT01726608

First Posted

November 11, 2012

Last Updated

January 28, 2013

Sponsor

Barts & The London NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT01726608

Brief Title

RFN for SIJ Disease Study

Official Title

A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacro Iliac Joint Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency neurotomy

Arm Type

Active Comparator

Arm Description

Active Radiofrequency Neurotomy

Arm Title

Sham

Arm Type

Placebo Comparator

Arm Description

Sham radiofrequency neurotomy

Intervention Type

Procedure

Intervention Name(s)

Comparison of active versus sham radiofrequency neurotomy with Simplicity III

Primary Outcome Measure Information:

Title

Pain Intensity

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pain Intensity

Time Frame

6 months

Title

Quality of pain

Description

Short Form Mcgill Pain Questionnaire

Time Frame

3 and 6 months

Title

Health related Quality of life

Description

Short form health survey

Time Frame

3 and 6 months

Title

Anxiety and Depression

Description

Hospital and Depression Scale

Time Frame

3 and 6 months

Title

Functional Disability

Description

Oswestry Low Back Pain Disability Questionnaire

Time Frame

3 and 6 months

Title

Health related quality of life and quality-adjusted life years

Description

Euro Quol EQ-5D scale

Time Frame

3 and 6 months

Title

Portion of patients randomised to sham requiring rescue therapy with RFN

Time Frame

3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written, informed consent Age: 18 - 80 years old 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. 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. 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. No vulnerable patient groups shall be recruited into this study Exclusion Criteria: Subjects who do not fulfill inclusion criteria Subjects who have previously been treated by any sacroiliac joint radiofrequency neurotomy Subjects who are breastfeeding Contraindications to local anaesthetics and radiofrequency neurotomy as listed in their respective summary of product characteristics Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality 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 Subjects' known to have a condition that, in the investigator's judgment precludes entry into the study. Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication. Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding study entry. Subjects unable to comply with the study assessments or unable to complete the questionnaires.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vivek Mehta, MD FRCA

Phone

+442034655361

vivek.mehta@bartshealth.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Sibtain Anwar, MA MB FRCA

Phone

+442034655361

sibtain.anwar@bartshealth.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek Mehta, MD FRCA

Organizational Affiliation

Barts & The London NHS Trust

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sibtain Anwar, MA MB FRCA

Organizational Affiliation

Barts & The London NHS Trust

Official's Role

Study Director

Facility Information:

Facility Name

Barts Health NHS Trust

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

30508988

Citation

Mehta V, Poply K, Husband M, Anwar S, Langford R. The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial. Pain Physician. 2018 Nov;21(6):607-618.

Results Reference

derived

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