Sacro Iliac Joint PainPhase 4NCT01726608
RFN for SIJ Disease Study
A Phase 4 study of Sacro Iliac Joint Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sacro Iliac Joint Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.
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.
- Conditions
- Sacro Iliac Joint Pain
- Being tested
- Comparison of active versus sham radiofrequency neurotomy with Simplicity III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of active versus sham radiofrequency neurotomy with Simplicity IIIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency neurotomy | Active comparator | Active Radiofrequency Neurotomy Receives: Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III |
| Sham | Placebo comparator | Sham radiofrequency neurotomy Receives: Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured: 3 months
Secondary outcomes (7)
Pain Intensity
Measured: 6 months
Quality of pain
Short Form Mcgill Pain Questionnaire
Measured: 3 and 6 months
Health related Quality of life
Short form health survey
Measured: 3 and 6 months
Anxiety and Depression
Hospital and Depression Scale
Measured: 3 and 6 months
Functional Disability
Oswestry Low Back Pain Disability Questionnaire
Measured: 3 and 6 months
Health related quality of life and quality-adjusted life years
Euro Quol EQ-5D scale
Measured: 3 and 6 months
Portion of patients randomised to sham requiring rescue therapy with RFN
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacro Iliac Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivek Mehta, MD FRCA, Principal investigator, Barts & The London NHS TrustSibtain Anwar, MA MB FRCA, Study director, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726608
- Sponsor's protocol ID
- Reda 7869
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2012
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30508988
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.
- ClinicalTrials.gov ID
- NCT01726608
- Acronym / sponsor ID
- Reda 7869
- Conditions
- Sacro Iliac Joint Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency neurotomy | Active comparator | Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity IIIActive Radiofrequency Neurotomy |
| Sham | Placebo comparator | Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity IIISham radiofrequency neurotomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of active versus sham radiofrequency neurotomy with Simplicity III | Procedure or surgery | Radiofrequency neurotomy, Sham |
Primary outcome
Pain Intensity
Time frame: 3 months
7 secondary outcomes
Pain Intensity
Time frame: 6 months
Quality of pain
Time frame: 3 and 6 months
Health related Quality of life
Time frame: 3 and 6 months
Anxiety and Depression
Time frame: 3 and 6 months
Functional Disability
Time frame: 3 and 6 months
Health related quality of life and quality-adjusted life years
Time frame: 3 and 6 months
Portion of patients randomised to sham requiring rescue therapy with RFN
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 30508988Mehta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Mehta, MD FRCA principal investigator
Barts & The London NHS Trust
Sibtain Anwar, MA MB FRCA study director
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Sacro Iliac Joint Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.