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OpenTrials
Completed

NCT Number: NCT02346383

Optimal Stimulation Programming for Spinal Peripheral Neuromodulation

To determine the best parameters with various leads to cover back and leg pain and provide best pain relief

Completed

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Key information

Conditions

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

Age range

22 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Center For Advanced Management of Pain

Spartanburg, South Carolina, 29303, United States

About this study

Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • spinal cord stimulator implant within last 3 weeks
  • NRS > 6
  • at least 22 years old
  • patients who agree not to add or increase their pain medications during the study

Exclusion criteria

  • patients with prior spinal cord stimulators
  • pregnancy
  • infusion pump
  • history of substance abuse or dependency in last 6 months

Treatment and study plan

preset program

Device

Change to different present program using epidural and peripheral lead to cover pain

Other names: epidural and peripheral lead to cover pain (Spinal Cord Stimulator)

Primary outcomes

  1. Numeric Rating Scale (Pain)

    Time frame: Weeks 4, 6 and 8

    0 (no pain)- 10 (worst pain imaginable)

Secondary outcomes

  1. Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.

    Time frame: weeks 4, 6, and 8

    percentage of pain relief- self report

Sponsors and collaborators

Lead sponsor

Carolinas Center for Advanced Management of Pain

Other

Collaborators

  • Abbott Medical Devices

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2015
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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