Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

Neuropathic Pain Clinical Trial

Official title:

Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479787
• Other study ID #: ABT-CIP-10343
• Status: Completed
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: February 26, 2024

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.

Description:

A prospective, multi-center, randomized, controlled clinical study with an optional crossover component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of chronic axial low back pain with a neuropathic component, compared to conventional medical management (CMM).

Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired.

The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 26, 2024
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.

2. Age = 18 years

3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery

4. Patient has back pain for = 6 months inadequately responsive to supervised conservative care

5. Patient has not had spine surgery for back or leg pain

6. Patient is a candidate for spinal cord stimulation

7. Low back pain = 6 on Numerical Rating Scale

8. Oswestry Disability Index score of = 30%

9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

Exclusion Criteria:

1. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.

2. Primary complaint of leg pain, or leg pain is greater than back pain

3. Back pain is due to any of the following:

• spinal instability defined as > 2 mm translation on radiographic imaging

• visceral causes (e.g., endometriosis or fibroids)

• vascular causes (e.g., aortic aneurysm)

• spinal infection (e.g., osteomyelitis)

• inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)

• tumor or spinal metastases

4. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)

5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)

6. Neurological deficit (e.g. foot drop)

7. Prior lumbar spine surgery or sacroiliac joint fusion

8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days

9. Patient is bed bound

10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)

11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement

12. Known allergic reaction to implanted materials

13. Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine)

14. Patient has a history of, or existing intrathecal drug pump

15. Patient has previous experience with neuromodulation devices, including a failed trial

16. BMI > 40

17. Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel

18. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.

19. Failed psychological evaluation

20. Suspicion or evidence of untreated mental illness, or substance abuse

21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior

22. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation

23. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

• Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-Back Pain
• Low Back Pain
• Neuralgia
• Neuropathic Pain
• Pain, Intractable
• Refractory Pain

Intervention

Device:
• Spinal Cord Stimulation
Utilization of BURSTDR stimulation

Other:
• Conventional Medical Management
Assessing type of CMM, location and frequency.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Spanish Hills Interventional Pain Specialists	Camarillo	California
United States	Coastal Pain & Spinal Diagnostics Medical Group	Carlsbad	California
United States	Indiana Spine Group	Carmel	Indiana
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	The Spine & Nerve Center of St Francis Hospital	Charleston	West Virginia
United States	Saint Louis Pain Consultants	Chesterfield	Missouri
United States	Chicago Anesthesia Associates	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Axis Spine Center	Coeur d'Alene	Idaho
United States	Northshore University Health System	Evanston	Illinois
United States	Center for Interventional Pain & Spine	Exton	Pennsylvania
United States	The Orthopedic Institute	Gainesville	Florida
United States	Connecticut Orthopedic Specialists	Hamden	Connecticut
United States	Advanced Pain Care	Henderson	Nevada
United States	Goodman Campbell Brain & Spine	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Napa Valley Orthopedic Medical Group	Napa	California
United States	Barrow Brain & Spine	Phoenix	Arizona
United States	Summit Spine	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Nevada Advanced Pain Specialists	Reno	Nevada
United States	Mayo Clinic	Rochester	Minnesota
United States	Burkhart Research Institute for Orthopaedics	San Antonio	Texas
United States	Carolina Orthopedics and Neurosurgical Associates	Spartanburg	South Carolina
United States	Anesthesia Pain Care Consultants	Tamarac	Florida
United States	Spinal Diagnostics	Tualatin	Oregon
United States	Banner University Medical Center	Tucson	Arizona
United States	International Spine, Pain & Performance Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Difference in Responders Between Both Groups	Improvement in pain, defined as percentage of patients who report a = 50% decrease on NRS	6 Months
Secondary	Measure of Composite Responder Rate	Composite Responder rate describes percentage of patients who responded on NRS OR ODI improvements (percentage of patients who report at least =13 change on ODI from baseline OR a = 50% decrease in NRS from baseline)	6 Months
Secondary	Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months	The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain (the worst pain imaginable). Lower scores indicate pain reduction. The data is expressed as relative change (%).	Baseline to 6 Months
Secondary	Oswestry Disability Index (ODI) Change From Baseline to 6 Months	The Oswestry Disability Index questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. An interpretation of 0% to 20% means minimal disability;21% to 40% means moderate disability; 41% to 60% means severe disability; 61% to 80% means crippled; and 81%-100% means bed-bound patients. Lower scores indicate less disability.	Baseline to 6 Months
Secondary	Pain Catastrophizing Scale (PCS) Responder Rate	The Pain Catastrophizing Scale questionnaire is a three part question that measures three pain domains: Rumination (e.g. "I can´t stop thinking about how much it hurts"); Magnification (e.g. "I´m afraid that something serious might happen"); Helplessness (e.g. "There is nothing I can do to reduce the intensity of my pain"). The Pain Catastrophizing Scale questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The questionnaire includes 13 statements describing different thoughts and feelings that may be associated with pain. Using the scale 0-4 (0- not at all; 1- to a slight degree; 2- to a moderate degree; 3- to a great degree; and 4- all the time), the patients are expected to indicate the degree to which they have these thoughts and feelings when they're experiencing pain. Lower scores indicate less catastrophizing thoughts.	6 Months
Secondary	Patient Global Impression of Change (PGIC) Responder Rate	PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The percentage of patients who reported "very much improved," or "much improved," are presented.	6 Months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months	The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome). Pain Interferences: Normal: <55; Mild: 55 - 60; Moderate: 60 -70; and Severe: >70.	Baseline to 6 Months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months	The PROMIS-29 physical function sub-scale includes 4 questions. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome). Physical function- Normal: >45; Mild: 40 - 45; Moderate: 30 - 40; and Severe: >30.	Baseline to 6 Months