Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain

NCT03601949 | Completed FDA Device

• 1 other identifier: 105-17-0002
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 15

Brief 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. 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).

Conditions

Sacroiliac Joint Pain

Keywords

Back Pain; Low Back Pain; Sacroiliac Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline and 3 months

• Mean change in score of Patient Global Impression of Change (PGIC)

  Baseline and 3 months

• Mean change in score of Short Form 36-Physical Functioning (SF36-PF)

  Baseline and 3 months

• Mean change in score of Oswestry Disability Index (ODI)

  Baseline and 3 months

• Mean change in score of EuroQuol (EQ) 5D-5L

  Baseline and 3 months

Other Outcomes (4)

• The mean change in pain-related medication

  Baseline and 3 months

• Healthcare Utilization Questionnaire

  Baseline and 3 months

• Time from treatment to return to work/duty

  3 months post-intervention

Study Arms (2)

SInergy Cooled Radiofrequency

EXPERIMENTAL

Halyard Health SInergy Cooled Radiofrequency in addition to standard medical management

Device: SInergy Cooled Radiofrequency; Other: Medical Management

Medical Management

ACTIVE COMPARATOR

Standard Medical Management

Other: Medical Management

Interventions

SInergy Cooled Radiofrequency DEVICE

ablation of low back pain

Also known as: SInergy

SInergy Cooled Radiofrequency

Medical Management OTHER

physical therapy, medications, lifestyle changes

Also known as: Standard Medical Management

Medical Management; SInergy Cooled Radiofrequency

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Avanos Medical: lead

Study Sites (15)

Mehul Desai

Washington D.C., District of Columbia, 20037, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61704, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70115, United States

Location

Shravani Durbhakula

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Adam Carinci

Rochester, New York, 14642, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28307, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Clinical Investigations

Edmond, Oklahoma, 73013, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lynn Kohan

Charlottesville, Virginia, 22903, United States

Location

Michael DePalma

Richmond, Virginia, 23235, United States

Location

Related Publications (2)

• 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. 2025 Mar 15:rapm-2024-106315. doi: 10.1136/rapm-2024-106315. Online ahead of print.

  PMID: 40089310 DERIVED

• Cohen 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.

  PMID: 37407279 DERIVED

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• David Curd, MS

  Avanos Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is an assessor blinded trial and deliberate action will be needed to ensure the blind remains. This begins with randomization procedures and carries through the follow up visits. It is suggested that all follow up visit documentation not contain the visit number, but instead utilize visit dates to track progress.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 26, 2018
• Study Start: June 29, 2018
• Primary Completion: August 9, 2021
• Study Completion: June 23, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

US (15)