Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery

Pain, Chronic Clinical Trial

Official title:

Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442410
• Other study ID #: MDT24011
• Secondary ID: ISRCTN10663814
• Status: Completed
• Phase: N/A
• Start date: July 24, 2020
• Est. completion date: October 17, 2023

Study information

• Verified date: June 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 17, 2023
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be a candidate for SCS system (trial and implant)
• Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
• Has an average back pain intensity = 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
• Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
• Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
• Be 18 years of age or older at the time of enrollment
• Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
• Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

• Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
• Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
• Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator
• Be concurrently participating in another clinical study
• Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
• Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
• Has mechanical spine instability as determined by the Investigator
• Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
• Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
• Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
• Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Pain, Chronic
• Pain, Intractable

Intervention

Device:
• DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system
Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.

Other:
• Conventional Medical Management (CMM)
The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar

Locations

Country	Name	City	State
Belgium	AZ Delta	Roeselare
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	GZA - Sint Augustinus Ziekenhuis	Wilrijk
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	München Klinik Bogenhausen	München
Netherlands	Rijnstate - Locatie Elst	Elst
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Diakonessenhuis Locatie Zeist	Zeist
Spain	Hospital Clínico Universitario de Santiago	A Coruña
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
MedtronicNeuro	SGX International LLC

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%	6 months
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	1 month
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	3 months
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	9 months
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	12 months
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	18 months
Secondary	Percentage of Individual Responders	Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	24 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	1 month
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	3 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	6 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	9 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	12 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	18 months
Secondary	Change from Baseline in Visual Analog Scale (VAS) back pain score	Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.	24 months

External Links

•   ISRCTN Registry posting