Sacroiliac Joint Pain Clinical Trial
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
NCT number | NCT03601949 |
Other study ID # | 105-17-0002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 29, 2018 |
Est. completion date | June 23, 2022 |
Verified date | March 2023 |
Source | Avanos Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 210 |
Est. completion date | June 23, 2022 |
Est. primary completion date | August 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 110 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Shravani Durbhakula | Baltimore | Maryland |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Millennium Pain Center | Bloomington | Illinois |
United States | Lynn Kohan | Charlottesville | Virginia |
United States | Brigham and Women's Hospital | Chestnut Hill | Massachusetts |
United States | Clinical Investigations | Edmond | Oklahoma |
United States | Womack Army Medical Center | Fort Bragg | North Carolina |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Michael DePalma | Richmond | Virginia |
United States | Adam Carinci | Rochester | New York |
United States | Premier Pain Centers | Shrewsbury | New Jersey |
United States | Mehul Desai | Washington | District of Columbia |
United States | The Center for Clinical Research | Winston-Salem | North Carolina |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Avanos Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The mean change in pain-related medication | The absolute mean difference between analgesic use at baseline and that at 3 months post-randomization. | Baseline and 3 months | |
Other | Healthcare Utilization Questionnaire | 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. | Baseline and 3 months | |
Other | Time from treatment to return to work/duty | Trial subject will be asked if/when she/he returned to work/duty | 3 months post-intervention | |
Other | Time from treatment to return of pain date | Trial subject will be asked if/when she/he experienced a return of pain | 3 months post-intervention | |
Primary | 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 | 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. | Baseline and 3 months | |
Secondary | 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. | Baseline and 3 months | |
Secondary | 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. | Baseline and 3 months | |
Secondary | 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. | Baseline and 3 months | |
Secondary | 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. | Baseline and 3 months |
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