NCT02371122

Brief Summary

The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

February 19, 2015

Last Update Submit

July 9, 2015

Conditions

Failed Back Surgery SyndromeDegenerative Disk DiseaseEpidural FibrosisArachnoiditisRadiculopathies

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale - Leg pain

    12 weeks

Secondary Outcomes (5)

  • Brief Pain Inventory - Pain severity

    12 weeks

  • Brief Pain Inventory - Pain interference

    12 weeks

  • Quantitative Sensory Testing - Vibration threshold

    12 weeks

  • Quantitative Sensory Testing - Electrical stimuli tolerance

    12 weeks

  • Numeric Pain Rating Scale - Back pain

    12 weeks

Study Arms (4)

RestoreSensor or RestoreUltra Setting 1

ACTIVE COMPARATOR

Therapy Setting 1

Device: Therapy Setting 1 (Medtronic)

RestoreSensor or RestoreUltra Setting 2

ACTIVE COMPARATOR

Therapy Setting 2

Device: Therapy Setting 2 (Medtronic)

RestoreSensor or RestoreUltra Setting 3

ACTIVE COMPARATOR

Therapy Setting 3

Device: Therapy Setting 3 (Medtronic)

RestoreSensor or RestoreUltra Setting 4

SHAM COMPARATOR

Therapy Setting 4

Device: Therapy Setting 4 (Medtronic)

Interventions

Therapy Setting 1 (Medtronic)DEVICE

RestoreSensor or RestoreUltra Setting 1

RestoreSensor or RestoreUltra Setting 1
Therapy Setting 2 (Medtronic)DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 2

RestoreSensor or RestoreUltra Setting 2
Therapy Setting 3 (Medtronic)DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 3

RestoreSensor or RestoreUltra Setting 3
Therapy Setting 4 (Medtronic)DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 4

RestoreSensor or RestoreUltra Setting 4

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 22 years of age or older at the time of informed consent
  • Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
  • Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
  • Receiving some level of pain relief with current SCS therapy
  • On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
  • Read and understand English without assistance
  • Willing and able to comply with all study procedures, study visits, and be available for the duration of the study

You may not qualify if:

  • Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
  • Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
  • Implanted with both a surgical and percutaneous lead
  • Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
  • Has had any of the following procedures:
  • Neuroablative procedure within six months
  • Neurolytic block within two months
  • Injection therapy for pain within four weeks
  • Sympathetic block within two weeks
  • Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF
  • Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study
  • Has an untreated psychiatric comorbidity
  • Has serious drug-related behavioral issues
  • Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year
  • Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Failed Back Surgery SyndromeArachnoiditisRadiculopathy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and SymptomsMeningitisNeuroinflammatory DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

July 10, 2015

Record last verified: 2015-07