Sacroiliac Joint PainNCT03601949
Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain
A study testing SInergy Cooled Radiofrequency and Medical Management in people with Sacroiliac Joint Pain, run by Avanos Medical at 15 sites in United States.
Trial summary
This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- SInergy Cooled Radiofrequency and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Jun 2018to 23 Jun 2022
- Phase
- Interventional
- 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 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 21 years.
- Able to understand the informed consent, and able to complete outcome measures.
- Sacroiliac joint (SIJ) pain that is refractory to standard of care treatments such as non-steroidal anti-inflammatory drugs (NSAIDS), physical therapy, etc.
- At least one positive SIJ pain provocation test (Distraction, Gaenslen's, FABER, Sacral Sulcus tenderness, thigh thrust, compression or sacral thrust).
- Back pain is predominantly below the lumbar (L) 5 vertebrae.
- Chronic low back pain lasting for longer than three months.
Show all 14Show fewer
- Greater than 50% pain relief lasting for the expected duration of anesthetic or medication from a therapeutic or diagnostic SIJ injection.
- Greater than 50% pain relief lasting the duration of anesthetic from lateral branch block (done on different days than SIJ injection).
- Stabilized on pain medication regimen for > 2 months, as defined by a < 10% change in dosage.
- Numeric rating scale indicating an average pain score of > 4 over the last seven days. (returned to pre-lateral branch block baseline pain).
- All other possible sources of low back pain have been ruled out as the primary pain generator, including, but not limited to: suspected advanced degenerative joint disease, the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and magnetic resonance imaging/computed tomography/X-ray, as required).
- Willing to utilize double barrier contraceptive method, if of child-bearing potential.
- Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
- Physician believes ablation of the SIJ is an appropriate treatment for the patient.
Who cannot join
- Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the treating physician.
- Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at vertebrae L5/sacroiliac (S) 1, or scoliosis.
- Symptomatic moderate or severe foraminal or central canal stenosis.
- Systemic infection or localized infection at anticipated introducer entry site.
- Uncontrolled immunosuppression (e.g., acquired immune deficiency syndrome (AIDS), cancer, diabetes, etc.)
- Chronic severe conditions such as rheumatoid/inflammatory arthritis.
Show all 18Show fewer
- Pregnancy or recent delivery (within three months).
- Active radiculopathy pain from lumbar spine.
- Active hip pathology.
- Major surgery within three months prior to signing informed consent.
- Prior radiofrequency denervation of the lateral sacral nerves.
- Ongoing/unresolved worker's compensation, injury litigation, military medical board, or disability remuneration claims.
- Allergy to injected substances or medications used in procedure.
- Body mass index (BMI) > 40 kilograms/meter (squared).
- Current prescribed opioid medications equivalent to 90 mg of morphine per 24 hours or greater.
- Subject is currently implanted with pacemaker, stimulator, or defibrillator.
- Participation in another clinical trial/investigation that could interfere with this trial 30 days prior to signing informed consent.
- Subject is unwilling or unable to comply with the protocol requirements.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Shravani Durbhakula
Baltimore, Maryland, 21287
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Millennium Pain Center
Bloomington, Illinois, 61704
Lynn Kohan
Charlottesville, Virginia, 22903
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Clinical Investigations
Edmond, Oklahoma, 73013
Womack Army Medical Center
Fort Bragg, North Carolina, 28307
Ochsner Medical Center
New Orleans, Louisiana, 70115
Oregon Health and Science University
Portland, Oregon, 97239
Michael DePalma
Richmond, Virginia, 23235
Adam Carinci
Rochester, New York, 14642
Premier Pain Centers
Shrewsbury, New Jersey, 07702
Mehul Desai
Washington D.C., District of Columbia, 20037
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective, Multi-center, Randomized, Assessor Blind, Controlled Study Comparing Lateral Branch Cooled Radiofrequency Denervation to Conservative Therapy as Treatment for Sacroiliac Joint Pain in a Military and Civilian Population
This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either Sacroiliac denervation using CRF (treatment group) or standard medical management ("SMM," control group).
Read the detailed description
This study will be a 12-month prospective, randomized, controlled, prospective, open-label, multi-center clinical study. Adult subjects over the age of 21 with diagnosed chronic intractable sacroiliac joint pain (≥ 3 months), who have been previously unresponsive to conservative therapy and who meet the selection criteria are eligible to participate in this study. Approximately 208 subjects will be enrolled at up to 15 sites in a 1:1 randomization ratio to receive either denervation using the SInergy System (cooled radiofrequency (CRF), treatment group) or standard medical management (SMM, control group). Follow-up will be conducted for a total of 12 months post-Coolief (cooled radiofrequency ablation) procedure, with the primary endpoint being completed at month 3. The control arm will utilize physician prescribed standard medical management (SMM). For this protocol, this includes, but is not limited to, medications, physical therapy, lifestyle changes, acupuncture, yoga, chiropractic, and therapeutic injections. An optional crossover-to-treatment design was adopted for subjects randomized to standard medical management after their 3-month visit, because it would be considered unethical to withhold treatment that could potentially offer pain relief to those subjects undergoing standard medical management who continue to suffer from pain.
Eligibility includes BOTH of the following:
- 50% pain relief lasting for the expected duration of anesthetic or medication from a therapeutic or diagnostic sacroiliac joint injection; AND
- 50% pain relief lasting for the expected duration of anesthetic from a standardized set of lateral branch blocks, with total volume of no more than 1 milliliter (ml) of 0.5% Bupivacaine, Ropivacaine (or similar). Ideally, 0.5 ml will be utilized at L5 and the remaining 0.5 ml should be divided in at least two locations along the foramen line
After the CRF treatment, the CRF treatment group subjects will visit the blinded assessor for follow up at 1, 3, 6, 9, and 12 months. At the month 3 visit (three months post-randomization), subjects initially randomized to the conservative therapy group will be assessed to determine eligibility to receive CRF treatment.
- If the conservative treatment subjects fail conservative therapy at 3 months (defined as failure to obtain a 2-point decrease in average pain score from baseline AND failure to obtain a rating of at least 5 on the Patient Global Impression of Change (PGIC) scale), they will be given the option of receiving CRF treatment.
- Subjects who choose to cross-over will ideally receive treatment within 30 days of their 3-month visit but they must receive treatment within 90 days of their 3-month visit. They will then be followed-up at 1, 3, 6, 9, and 12 months following CRF denervation (new Day 0).
- If the conservative treatment group subjects refuse or don't qualify for CRF treatment at 3 months, they will subsequently be followed-up at 6, 9, and 12 months from their Day 0.
Primary Analysis is planned after all initially treated subjects have completed their 3-month post-procedure visit.
- Conditions
- Sacroiliac Joint Pain
- Being tested
- SInergy Cooled Radiofrequency, Medical Management
- Keywords
- Back Pain, Low Back Pain, Sacroiliac Back Pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SInergy Cooled RadiofrequencyDevice
Also called SInergy
ablation of low back pain
Medical ManagementOther
Also called Standard Medical Management
physical therapy, medications, lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| SInergy Cooled Radiofrequency | Experimental | Halyard Health SInergy Cooled Radiofrequency in addition to standard medical management Receives: Device: SInergy Cooled Radiofrequency; Other: Medical Management |
| Medical Management | Active comparator | Standard Medical Management Receives: Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily pain Numeric Rating Scale (NRS) score
Numeric Rating Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Secondary outcomes (5)
The proportion of subjects with at least a 2 points decrease or 30% drop in average daily pain related NRS score AND a rating of at least 5 on the Patient Global Impression of Change (PGIC)
Numeric Rating Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group. PGIC - score range = 1 - 7. "1" corresponds to "very much improved" and "7" indicates "very much worse" pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Mean change in score of Patient Global Impression of Change (PGIC)
PGIC - score range = 1 - 7. "1" corresponds to "very much improved" and "7" indicates "very much worse" pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Mean change in score of Short Form 36-Physical Functioning (SF36-PF)
Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Mean change in score of Oswestry Disability Index (ODI)
ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Mean change in score of EuroQuol (EQ) 5D-5L
This tool involves two components: 1) descriptive system - five questions that are scored 1-5, each with "1" indicating no problems and "5" indicating the worst problem related to the question, and 2) EQ-Visual Analog Scale (VAS) - score range = 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start29 Jun 2018
- Primary completion9 Aug 2021
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanos Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Curd, MS, Study director, Avanos Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601949
- Sponsor's protocol ID
- 105-17-0002
- Status last verified
- Mar 2023
- First submitted
- 18 Jul 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Cohen SP, Kapural L, Kohan L, Li S, Hurley R, Vallejo R, Eshraghi Y, Dinakar P, Durbhakula S, Beall DP, Desai MJ, Reece D, Christiansen S, Chang MH, Carinci AJ, DePalma M. Cooled radiofrequency ablation provides extended clinical utility in the management of chronic sacroiliac joint pain: 12-month follow-up results from the observational phase of a randomized, multicenter, comparative-effectiveness crossover study. Reg Anesth Pain Med. 2026 Jun 5;51(6):660-669. doi: 10.1136/rapm-2024-106315.
PubMed 40089310Cohen SP, Kapural L, Kohan L, Li S, Hurley RW, Vallejo R, Eshraghi Y, Dinakar P, Durbhakula S, Beall DP, Desai MJ, Reece D, Christiansen S, Chang MH, Carinci AJ, DePalma M. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study. Reg Anesth Pain Med. 2024 Mar 4;49(3):184-191. doi: 10.1136/rapm-2023-104568.
PubMed 37407279
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Assessor Blind, Controlled Study Comparing Lateral Branch Cooled Radiofrequency Denervation to Conservative Therapy as Treatment for Sacroiliac Joint Pain in a Military and Civilian Population
- ClinicalTrials.gov ID
- NCT03601949
- Acronym / sponsor ID
- 105-17-0002
- Conditions
- Sacroiliac Joint Pain
- Keywords
- Back Pain, Low Back Pain, Sacroiliac Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Avanos MedicalUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
This is a prospective, randomized, controlled, multi-center clinical study. Approximately 208 subjects will be enrolled at approximately 12-15 active duty military, veterans' care, and civilian sites. Eligible subjects will be randomized in 1:1 ratio to receive either Sacroiliac denervation using CRF (treatment group) or standard medical management ("SMM," control group).
Detailed description
This study will be a 12-month prospective, randomized, controlled, prospective, open-label, multi-center clinical study. Adult subjects over the age of 21 with diagnosed chronic intractable sacroiliac joint pain (≥ 3 months), who have been previously unresponsive to conservative therapy and who meet the selection criteria are eligible to participate in this study. Approximately 208 subjects will be enrolled at up to 15 sites in a 1:1 randomization ratio to receive either denervation using the SInergy System (cooled radiofrequency (CRF), treatment group) or standard medical management (SMM, control group). Follow-up will be conducted for a total of 12 months post-Coolief (cooled radiofrequency ablation) procedure, with the primary endpoint being completed at month 3. The control arm will utilize physician prescribed standard medical management (SMM). For this protocol, this includes, but is not limited to, medications, physical therapy, lifestyle changes, acupuncture, yoga, chiropractic, and therapeutic injections. An optional crossover-to-treatment design was adopted for subjects randomized to standard medical management after their 3-month visit, because it would be considered unethical to withhold treatment that could potentially offer pain relief to those subjects undergoing standard medical management who continue to suffer from pain.
Eligibility includes BOTH of the following:
- 50% pain relief lasting for the expected duration of anesthetic or medication from a therapeutic or diagnostic sacroiliac joint injection; AND
- 50% pain relief lasting for the expected duration of anesthetic from a standardized set of lateral branch blocks, with total volume of no more than 1 milliliter (ml) of 0.5% Bupivacaine, Ropivacaine (or similar). Ideally, 0.5 ml will be utilized at L5 and the remaining 0.5 ml should be divided in at least two locations along the foramen line
After the CRF treatment, the CRF treatment group subjects will visit the blinded assessor for follow up at 1, 3, 6, 9, and 12 months. At the month 3 visit (three months post-randomization), subjects initially randomized to the conservative therapy group will be assessed to determine eligibility to receive CRF treatment.
- If the conservative treatment subjects fail conservative therapy at 3 months (defined as failure to obtain a 2-point decrease in average pain score from baseline AND failure to obtain a rating of at least 5 on the Patient Global Impression of Change (PGIC) scale), they will be given the option of receiving CRF treatment.
- Subjects who choose to cross-over will ideally receive treatment within 30 days of their 3-month visit but they must receive treatment within 90 days of their 3-month visit. They will then be followed-up at 1, 3, 6, 9, and 12 months following CRF denervation (new Day 0).
- If the conservative treatment group subjects refuse or don't qualify for CRF treatment at 3 months, they will subsequently be followed-up at 6, 9, and 12 months from their Day 0.
Primary Analysis is planned after all initially treated subjects have completed their 3-month post-procedure visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SInergy Cooled Radiofrequency | Experimental | Device: SInergy Cooled Radiofrequency, Other: Medical ManagementHalyard Health SInergy Cooled Radiofrequency in addition to standard medical management |
| Medical Management | Active comparator | Other: Medical ManagementStandard Medical Management |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age greater than or equal to 21 years.
- Able to understand the informed consent, and able to complete outcome measures.
- Sacroiliac joint (SIJ) pain that is refractory to standard of care treatments such as non-steroidal anti-inflammatory drugs (NSAIDS), physical therapy, etc.
- At least one positive SIJ pain provocation test (Distraction, Gaenslen's, FABER, Sacral Sulcus tenderness, thigh thrust, compression or sacral thrust).
- Back pain is predominantly below the lumbar (L) 5 vertebrae.
Key exclusion criteria (18 listed)
- Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the treating physician.
- Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at vertebrae L5/sacroiliac (S) 1, or scoliosis.
- Symptomatic moderate or severe foraminal or central canal stenosis.
- Systemic infection or localized infection at anticipated introducer entry site.
- Uncontrolled immunosuppression (e.g., acquired immune deficiency syndrome (AIDS), cancer, diabetes, etc.)
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 |
|---|---|---|
| SInergy Cooled RadiofrequencyAlso: SInergyablation of low back pain | Device | SInergy Cooled Radiofrequency |
| Medical ManagementAlso: Standard Medical Managementphysical therapy, medications, lifestyle changes | Other | Medical Management, SInergy Cooled Radiofrequency |
Primary outcome
Change in average daily pain Numeric Rating Scale (NRS) score
Time frame: Baseline and 3 months
Numeric Rating Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
5 secondary outcomes
The proportion of subjects with at least a 2 points decrease or 30% drop in average daily pain related NRS score AND a rating of at least 5 on the Patient Global Impression of Change (PGIC)
Time frame: Baseline and 3 months
Mean change in score of Patient Global Impression of Change (PGIC)
Time frame: Baseline and 3 months
Mean change in score of Short Form 36-Physical Functioning (SF36-PF)
Time frame: Baseline and 3 months
Mean change in score of Oswestry Disability Index (ODI)
Time frame: Baseline and 3 months
Mean change in score of EuroQuol (EQ) 5D-5L
Time frame: Baseline and 3 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 22 Mar 2023.
- Derived from this study: PubMed 40089310Cohen SP, Kapural L, Kohan L, Li S, Hurley R, Vallejo R, Eshraghi Y, Dinakar P, Durbhakula S, Beall DP, Desai MJ, Reece D, Christiansen S, Chang MH, Carinci AJ, DePalma M. Cooled radiofrequency ablation provides extended clinical utility in the management of chronic sacroiliac joint pain: 12-month follow-up results from the observational phase of a randomized, multicenter, comparative-effectiveness crossover study. Reg Anesth Pain Med. 2026 Jun 5;51(6):660-669. doi: 10.1136/rapm-2024-106315.
- Derived from this study: PubMed 37407279Cohen SP, Kapural L, Kohan L, Li S, Hurley RW, Vallejo R, Eshraghi Y, Dinakar P, Durbhakula S, Beall DP, Desai MJ, Reece D, Christiansen S, Chang MH, Carinci AJ, DePalma M. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study. Reg Anesth Pain Med. 2024 Mar 4;49(3):184-191. doi: 10.1136/rapm-2023-104568.
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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.
David Curd, MS study director
Avanos Medical
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SInergy Cooled Radiofrequency and Medical Management in people with Sacroiliac Joint Pain, run by Avanos Medical at 15 sites in United States.
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 14 inclusion and 18 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in average daily pain Numeric Rating Scale (NRS) score (time frame: Baseline and 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 NCT03601949, which also lists 2 linked publications.
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 22 Mar 2023.