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Trial record 1 of 1 for:    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
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Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain

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ClinicalTrials.gov Identifier: NCT03601949
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Avanos Medical

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).

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Pain Device: SInergy Cooled Radiofrequency Other: Medical Management Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: SInergy Cooled Radiofrequency
Halyard Health SInergy Cooled Radiofrequency in addition to standard medical management
Device: SInergy Cooled Radiofrequency
ablation of low back pain
Other Name: SInergy

Other: Medical Management
physical therapy, medications, lifestyle changes
Other Name: Standard Medical Management

Active Comparator: Medical Management
Standard Medical Management
Other: Medical Management
physical therapy, medications, lifestyle changes
Other Name: Standard Medical Management




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Mean change in score of Patient Global Impression of Change (PGIC) [ Time Frame: Baseline and 3 months ]
    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.

  3. Mean change in score of Short Form 36-Physical Functioning (SF36-PF) [ Time Frame: Baseline and 3 months ]
    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.

  4. Mean change in score of Oswestry Disability Index (ODI) [ Time Frame: Baseline and 3 months ]
    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.

  5. Mean change in score of EuroQuol (EQ) 5D-5L [ Time Frame: Baseline and 3 months ]
    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.


Other Outcome Measures:
  1. The mean change in pain-related medication [ Time Frame: Baseline and 3 months ]
    The absolute mean difference between analgesic use at baseline and that at 3 months post-randomization.

  2. Healthcare Utilization Questionnaire [ Time Frame: Baseline and 3 months ]
    Used to evaluate the use or need for other healthcare treatments (e.g., physical therapy, visit(s) to chiropractor). The evaluation is not based on a point-based scale, but rather is based on responses made by trial subjects to the questions, with the determination made by the investigator.

  3. Time from treatment to return to work/duty [ Time Frame: 3 months post-intervention ]
    Trial subject will be asked if/when she/he returned to work/duty

  4. Time from treatment to return of pain date [ Time Frame: 3 months post-intervention ]
    Trial subject will be asked if/when she/he experienced a return of pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 21 years.
  2. Able to understand the informed consent, and able to complete outcome measures.
  3. Sacroiliac joint (SIJ) pain that is refractory to standard of care treatments such as non-steroidal anti-inflammatory drugs (NSAIDS), physical therapy, etc.
  4. At least one positive SIJ pain provocation test (Distraction, Gaenslen's, FABER, Sacral Sulcus tenderness, thigh thrust, compression or sacral thrust).
  5. Back pain is predominantly below the lumbar (L) 5 vertebrae.
  6. Chronic low back pain lasting for longer than three months.
  7. Greater than 50% pain relief lasting for the expected duration of anesthetic or medication from a therapeutic or diagnostic SIJ injection.
  8. Greater than 50% pain relief lasting the duration of anesthetic from lateral branch block (done on different days than SIJ injection).
  9. Stabilized on pain medication regimen for > 2 months, as defined by a < 10% change in dosage.
  10. Numeric rating scale indicating an average pain score of > 4 over the last seven days. (returned to pre-lateral branch block baseline pain).
  11. 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).
  12. Willing to utilize double barrier contraceptive method, if of child-bearing potential.
  13. Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
  14. Physician believes ablation of the SIJ is an appropriate treatment for the patient.

Exclusion Criteria:

  1. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the treating physician.
  2. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at vertebrae L5/sacroiliac (S) 1, or scoliosis.
  3. Symptomatic moderate or severe foraminal or central canal stenosis.
  4. Systemic infection or localized infection at anticipated introducer entry site.
  5. Uncontrolled immunosuppression (e.g., acquired immune deficiency syndrome (AIDS), cancer, diabetes, etc.)
  6. Chronic severe conditions such as rheumatoid/inflammatory arthritis.
  7. Pregnancy or recent delivery (within three months).
  8. Active radiculopathy pain from lumbar spine.
  9. Active hip pathology.
  10. Major surgery within three months prior to signing informed consent.
  11. Prior radiofrequency denervation of the lateral sacral nerves.
  12. Ongoing/unresolved worker's compensation, injury litigation, military medical board, or disability remuneration claims.
  13. Allergy to injected substances or medications used in procedure.
  14. Body mass index (BMI) > 40 kilograms/meter (squared).
  15. Current prescribed opioid medications equivalent to 90 mg of morphine per 24 hours or greater.
  16. Subject is currently implanted with pacemaker, stimulator, or defibrillator.
  17. Participation in another clinical trial/investigation that could interfere with this trial 30 days prior to signing informed consent.
  18. Subject is unwilling or unable to comply with the protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601949


Contacts
Contact: William Keck, BS 470-448-5509 william.keck@hyh.com
Contact: David Curd, MS 470-448-5178 david.curd@hyh.com

Locations
United States, District of Columbia
Mehul Desai Recruiting
Washington, District of Columbia, United States, 20037
Contact: Mehul Desai, MD    202-808-8295      
United States, New Jersey
Sean Li Recruiting
Shrewsbury, New Jersey, United States, 07702
Contact: Sean Li, MD    732-930-2423      
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Leonardo Kapural, MD    336-714-8381      
United States, Oklahoma
Clinical Investigations Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Douglas Beall, MD    405-601-2325      
United States, Virginia
Lynn Kohan Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Lynn Kohan, MD    434-243-5675      
Sponsors and Collaborators
Avanos Medical
Investigators
Study Director: David Curd, MS Avanos Medical

Responsible Party: Avanos Medical
ClinicalTrials.gov Identifier: NCT03601949     History of Changes
Other Study ID Numbers: 105-17-0002
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Avanos Medical:
Back Pain
Low Back Pain
Sacroiliac Back Pain

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms