180 Participants Needed

Spinal Cord Stimulation for Chronic Pain

Recruiting at 2 trial locations
BW
Overseen ByBrian Wainger, MD PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how spinal cord stimulation affects chronic pain in people with implanted devices. Participants will switch their devices on and off to observe how different settings impact their pain levels. It suits those who already have a spinal cord stimulator for back, neck, or limb pain and can manage their pain medication consistently. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants maintain a stable dose of opioids throughout the study. If you are taking benzodiazepines, you may need to stop, except for specific ones like alprazolam, clonazepam, and lorazepam, and you must have stopped at least five half-lives ago for certain imaging parts of the study.

What prior data suggests that spinal cord stimulation is safe for chronic pain patients?

Research has shown that spinal cord stimulation (SCS) is generally safe for people. Studies have found that these devices can safely treat chronic pain. In a worldwide study, data collected over two years revealed no major safety issues with SCS, indicating that most people did not experience serious problems over a long period.

Some individuals might feel side effects like tingling or discomfort at the implant site, but these are usually minor. The devices have been used successfully for various types of pain, indicating safety for many patients. Overall, spinal cord stimulators maintain a good safety record when used as intended.12345

Why are researchers excited about this trial?

Researchers are excited about exploring different spinal cord stimulation settings for chronic pain management. Unlike traditional pain management options that often rely on medications like opioids or non-invasive therapies, this approach directly targets the spinal cord to potentially alter pain signals. By comparing usual stimulation settings to minimal or no stimulation, researchers hope to determine the most effective way to utilize these implanted devices, possibly reducing dependency on medications and enhancing pain relief. This trial could lead to more personalized and efficient pain management strategies, offering new hope for those with chronic pain.

What evidence suggests that spinal cord stimulation is effective for chronic pain?

Research has shown that spinal cord stimulation (SCS) can relieve chronic pain, particularly in the back and legs. Studies have found that SCS often outperforms medication alone for these conditions. In this trial, participants will be assigned to different groups to evaluate SCS's effectiveness. One group will have their spinal cord stimulator set to minimal or no stimulation, while another group will use their usual settings. However, some studies suggest that SCS might not be more effective than a placebo for low back pain. This means that while many people find relief, it might not work for everyone. Overall, SCS appears promising, but its effectiveness can vary depending on the type of chronic pain.24678

Who Is on the Research Team?

BW

Brian Wainger, MD PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The device has a setting that does not cause a tingling feeling.
I can give informed consent and follow the trial's procedures.
You have a spinal cord or dorsal root ganglion stimulator that has been implanted for a while.
See 1 more

Exclusion Criteria

I am not using opioids, or if I am, my dose has been stable and under 100 morphine equivalents/day for the last two months.
My main pain is not from failed back surgery.
Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will have their spinal cord stimulators turned on or off for two-week intervals, up to six weeks after enrollment, in a multi-crossover design

6 weeks
Visits at baseline, week 2, and week 4 for imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
  • Usual Care
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Patients with Implanted Devices on Usual Stimulation SettingsExperimental Treatment2 Interventions
Group II: Patients with Implanted Devices on Minimal/No Stimulation SettingsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

Spinal cord stimulation (SCS) is a nonpharmacologic treatment for chronic pain, and the evaluation of its safety and efficacy has progressed to more rigorous randomized controlled trials (RCTs) despite challenges like blinding and control group selection.
A consensus meeting among three professional societies led to recommendations for improving SCS trial designs, including the use of placebo controls, double-blinding, and comprehensive reporting of outcomes to enhance the validity and reliability of study results.
Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations.Katz, N., Dworkin, RH., North, R., et al.[2023]
In a study of 100 patients with failed back surgery syndrome, those receiving spinal cord stimulation (SCS) alongside conventional medical management reported significantly better leg pain relief, quality of life, and functional capacity at 24 months compared to those receiving conventional management alone.
At the 24-month mark, 37% of patients who continued SCS achieved over 50% leg pain relief, compared to only 2% in the conventional management group, highlighting the long-term efficacy of SCS in this patient population.
The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation.Kumar, K., Taylor, RS., Jacques, L., et al.[2022]
Spinal cord stimulation (SCS) therapy for chronic back pain significantly improves physical function, as indicated by a reduction in Oswestry Disability Index (ODI) scores, with a mean difference of -17.00% at 12 months compared to baseline.
Despite these improvements, the evidence supporting the efficacy of SCS on physical function is rated as very low certainty due to high variability among studies, highlighting the need for further research to confirm these findings.
Physical functioning following spinal cord stimulation: a systematic review and meta-analysis.ElSaban, M., Kleppel, DJ., Kubrova, E., et al.[2023]

Citations

Spinal Cord Stimulation: Clinical Efficacy and Potential ...In rats with chronic dorsal column lesions, SCS was equally effective at relieving pain when applied at levels rostral or caudal to the lesion, with each site ...
Spinal Cord Stimulation vs Medical Management for ...This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...
Real World Characterization of Chronic Pain, Success ...Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation ...
Spinal Cord Stimulation Explantation: A Systematic Review ...SCS is an effective treatment for a range of chronic pain conditions, but the therapy requires better durability data to withstand criticism ...
Spinal cord stimulation doesn t help with back pain says ...The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with probably little to no benefit for people with ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36691862/
Long-term safety of spinal cord stimulation systems in a ...Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry ...
Spinal Cord Stimulator (SCS): What It Is & Side EffectsSpinal cord stimulators are medical devices that treat chronic pain. These devices can treat a wide range of pain types, and pain from different types of ...
Safety and Effectiveness Study of the Precision SCS ...Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance ...
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