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

Browse trials for

• Neuralgia 1,285
• Back Pain 2,374
• Low Back Pain 2,812
• Pain, Intractable 91

Keywords

• Chronic Low Back Pain
• Spinal Cord Stimulation

Study arms

• Active comparator
  Spinal Cord Stimulation (SCS)

  An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator

  Device: Spinal Cord Stimulation

• Active comparator
  Conventional Medical Management (CMM)

  CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)

  Other: Conventional Medical Management

Interventions

• DeviceSpinal Cord Stimulation

  Utilization of BURSTDR stimulation

  Also known as: Proclaim XR IPG

• OtherConventional Medical Management

  Assessing type of CMM, location and frequency.

  Also known as: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.

Primary outcomes

1. The Difference in Responders Between Both Groups

   Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).

   Time frame: 6 Months

Secondary outcomes

1. 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).

   Time frame: 6 Months

2. 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 (%).

   Time frame: Baseline to 6 Months

3. 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.

   Time frame: Baseline to 6 Months

4. Pain Catastrophizing Scale (PCS) Responder Rate

   The Pain Catastrophizing Scale questionnaire is a three part question that measures three pain domains: 1. Rumination (e.g. "I can´t stop thinking about how much it hurts") 2. Magnification (e.g. "I´m afraid that something serious might happen") 3. 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.

   Time frame: 6 Months

5. 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.

   Time frame: 6 Months

6. 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.

   Time frame: Baseline to 6 Months

7. 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.

   Time frame: Baseline to 6 Months

Baseline characteristics

Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2. PubMed 34854473 ↗

Study documents

• Study protocol · Apr 6, 2022
• Statistical analysis plan · Jan 12, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No