Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

NCT01550562 | Terminated Results

• 1 other identifier: A7002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Mean within-patient difference in average back pain intensity among treatment groups

  4,8,and 12 days post temporary lead(s) implantation

Secondary Outcomes (5)

• Pain Relief Responder Rate

  4,8,and 12 days post temporary lead(s) implantation

• Leg Pain Reduction

  4,8,and 12 days post temporary lead(s) implantation

• Disability

  4,8,and 12 days post temporary lead(s) implantation

• Percent Pain Relief

  4,8,and 12 days post temporary lead(s) implantation

• Quality of Life, as Measured by EQ-5D-5L

  4,8,and 12 days post temporary lead(s) implantation

Study Arms (3)

Sham Stimulation

PLACEBO COMPARATOR

Sham subthreshold spinal cord stimulation therapy

Device: Boston Scientific Precision Plus spinal cord stimulation therapy

Treatment 1

ACTIVE COMPARATOR

subthreshold spinal cord stimulation therapy

Device: Boston Scientific Precision Plus spinal cord stimulation therapy

Treatment 2

EXPERIMENTAL

subthreshold spinal cord stimulation therapy

Device: Boston Scientific Precision Plus spinal cord stimulation therapy

Interventions

Boston Scientific Precision Plus spinal cord stimulation therapy DEVICE

Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Sham Stimulation; Treatment 1; Treatment 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic intractable pain of the trunk and/or limbs
• Documented history of trunk and/or limb pain of at least 180 days
• Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
• Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
• If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
• Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
• Subject is able to independently read and complete all questionnaires and/or assessments provided in English
• years of age or older when written informed consent is obtained
• Subject signs a valid, Ethics Committee-approved informed consent form (ICF) provided in English

You may not qualify if:

• Unable to operate the PrecisionPlus™ system
• Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
• Is a high surgical risk
• Is diabetic
• Is immunocompromised
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period
• Untreated major depression or untreated generalized anxiety disorder
• Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
• Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
• Current abuse of alcohol or illicit drugs
• Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
• Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
• Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator
• Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result document)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Hunter Pain Clinic

Newcastle, New South Wales, 2292, Australia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Research Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Kay Adair

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-03

Locations

AU (1)