Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2021
• Main ID: NCT03082261
• Date of registration: 13/03/2017
• Prospective Registration: No
• Primary sponsor: Abbott Medical Devices
• Public title: Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator TRIUMPH
• Scientific title: Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
• Date of first enrolment: March 3, 2017
• Target sample size: 269
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03082261
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Marie Fahey
• Affiliation: Abbott

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery syndrome and
intractable low back and leg pain.

2. Subject has a score of 6 or higher on the numeric rating scale (NRS) for average pain
specific to the area(s) of chronic pain being treated over the past 24 hours at the
baseline visit.

3. Subject is considered by the Investigator as a candidate for implantation of a spinal
cord stimulator system according to the system Instructions For Use.

4. Subject is 18 years of age or older at the time of enrollment.

5. Subject is willing to cooperate with the study requirements including compliance with
the regimen and completion of all study visits.

6. Subject has signed and received a copy of the Ethics Committee/Institutional Review
Board (EC/IRB) approved informed consent.

Exclusion Criteria:

1. Subject currently has a spinal cord stimulation system implanted.

2. Subject has previously failed spinal cord stimulation (SCS) therapy (either trial
system evaluation or permanent implant).

3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris,
or Chronic Migraine.

4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral
Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or
implantable infusion pump.

5. Subject is currently participating in another clinical investigation with an active
treatment arm.

6. Subject unable to read and/or write.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intractable Pain

Chronic Pain

Intervention(s)

Device: Prodigy, Prodigy MRI or Proclaim Elite IPG

Primary Outcome(s)

Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) [Time Frame: Baseline to 6 Months]

Secondary Outcome(s)

Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9) [Time Frame: Baseline to 6 Months]

Mean Change in Physical Function From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale [Time Frame: Baseline to 6 Months]

Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire [Time Frame: Baseline to 6 Months]

Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK) [Time Frame: Baseline to 6 Months]

Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale [Time Frame: Baseline to 6 Months]

Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI) [Time Frame: Baseline to 6 Months]

Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS) [Time Frame: Baseline to 6 Months]

Secondary ID(s)

SJM-CIP-10145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03082261