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

Completed · Not applicable

Conditions studied: Sacroiliac Joint Pain

In brief

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).

Key facts

Study ID

NCT03601949

Run by

Avanos Medical

People needed

210

Starts

2018-06-29

Expected to finish

2022-06-23

Last updated by the study team

2023-03-22

Who can join

Age: 21 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Mehul Desai — Washington D.C., District of Columbia, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Shravani Durbhakula — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• Premier Pain Centers — Shrewsbury, New Jersey, United States
• Adam Carinci — Rochester, New York, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Clinical Investigations — Edmond, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Lynn Kohan — Charlottesville, Virginia, United States
• Michael DePalma — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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