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Spinal Cord Stimulation for Chronic Pain

N/A
Recruiting
Led By Brian Wainger, MD PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Device is to treat failed back surgery syndrome with back and radicular lower extremity pain
Aged 18 to 80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (enrollment) to six weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how spinal cord stimulators affect people with chronic pain. Patients will turn on/off their stimulator for periods of time to observe effects.

Who is the study for?
This trial is for adults aged 18-80 with chronic pain from failed back surgery, who have a spinal cord stimulator implanted. They must be able to give consent and report on their pain and function. People can't join if they have severe physical or mental health issues, are not on stable opioid doses, or can't distinguish their back surgery pain from other types.
What is being tested?
The study tests the effects of turning spinal cord stimulators on or off in two-week intervals over six weeks. Participants will also switch between having it on and off every hour during the last day of the study to see how this affects their chronic pain.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at the stimulator site, changes in pain sensation when switching stimulation settings, and possible psychological impacts due to fluctuations in perceived pain relief.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have ongoing back and leg pain after back surgery.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (enrollment) to six weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (enrollment) to six weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Supraexcitability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with Implanted Devices on Usual Stimulation SettingsExperimental Treatment1 Intervention
Patients in this arm will be randomized to turn on their spinal cord stimulator to their usual stimulation settings.
Group II: Patients with Implanted Devices on Minimal/No Stimulation SettingsExperimental Treatment1 Intervention
Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
652,039 Total Patients Enrolled
15 Trials studying Chronic Pain
2,144 Patients Enrolled for Chronic Pain
Massachusetts General HospitalLead Sponsor
3,020 Previous Clinical Trials
13,316,335 Total Patients Enrolled
30 Trials studying Chronic Pain
4,833 Patients Enrolled for Chronic Pain
Brian Wainger, MD PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT05661903 — N/A
Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05661903 — N/A
Chronic Pain Research Study Groups: Patients with Implanted Devices on Minimal/No Stimulation Settings, Patients with Implanted Devices on Usual Stimulation Settings
Chronic Pain Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT05661903 — N/A
~100 spots leftby Dec 2026
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