Spinal Cord Stimulation for Chronic Pain

Recruiting at 2 trial locations

Overseen By Brian Wainger, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines

Disqualifiers: Unstable opioid dose, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

180 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Spinal Cord Stimulation for chronic pain?

Research shows that spinal cord stimulation (SCS) can significantly reduce pain intensity and improve quality of life for people with chronic pain, such as those with failed back surgery syndrome and neuropathic pain. Studies have found that SCS provides better pain relief compared to conventional medical management and placebo treatments. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for treating chronic pain?

Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with a low rate of serious adverse events. In a global study, the most common serious issue was implant site infection, occurring in less than 1% of cases. ^{3 4 6 7 8}

How does spinal cord stimulation differ from usual care for chronic pain?

Spinal cord stimulation (SCS) is a unique treatment for chronic pain that involves implanting a device to send electrical impulses to the spinal cord, which can help reduce pain signals. Unlike usual care, which may include medications or physical therapy, SCS is an invasive procedure typically considered when other treatments have not been effective. ^{8 9 10 11 12}

What is the purpose of this trial?

This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for one hour intervals, in a multi-crossover design. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.

Research Team

Brian Wainger, MD PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Patients with Implanted Devices on Usual Stimulation Settings Experimental Treatment 2 Interventions

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 Settings Experimental Treatment 2 Interventions

Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).

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+

Findings from Research

Patients receiving high-frequency (10 kHz) spinal cord stimulators (SCS) experienced a significant reduction in opioid use, with an average decrease of 26.2 mg morphine equivalents, representing a 28% reduction from baseline, and 71.4% of these patients reduced their opioid dosage after 12 months.

The SCS group also reported significant reductions in pain scores for low back and lower extremity pain, with decreases of 46.2% and 50.9% respectively, indicating the effectiveness of SCS in managing pain compared to conventional medical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10 kHz spinal cord stimulation: a retrospective analysis of real-world data from a community-based, interdisciplinary pain facility. DiBenedetto, DJ., Wawrzyniak, KM., Schatman, ME., et al.[2022]

A meta-analysis of 8 randomized controlled trials found that spinal cord stimulation (SCS) significantly reduces pain intensity in patients with neuropathic pain compared to a placebo, with a mean difference of -1.15 on a 10-point scale.

The effectiveness of SCS appears to vary based on the type of control used in trials, with stronger effects observed in studies using a placebo control compared to those using a sham control, highlighting the importance of study design and patient blinding in evaluating treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain. Duarte, RV., Nevitt, S., McNicol, E., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A comprehensive review of 21 randomized controlled trials evaluated the efficacy of spinal cord stimulation (SCS) across various conditions, including trunk and limb pain, refractory angina, and diabetic neuropathy, providing a detailed analysis of clinical outcomes such as pain relief, quality of life, and patient satisfaction.

The study established outcome-specific evidence scores for each indication, helping both physicians and patients make informed decisions about SCS therapy based on a wide range of patient populations and treatment variations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation 50 Years Later: Clinical Outcomes of Spinal Cord Stimulation Based on Randomized Clinical Trials-A Systematic Review. Mekhail, N., Visnjevac, O., Azer, G., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 138 patients with chronic neuropathic pain, 74.7% experienced over 50% pain reduction after trialing spinal cord stimulation (SCS), leading to permanent implantation for most of them.

One year after implantation, 84.4% of patients maintained significant pain relief, and many reported improved daily functioning and reduced reliance on opiate analgesics, highlighting SCS as an effective treatment option in a multidisciplinary pain management setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. Sundaraj, SR., Johnstone, C., Noore, F., et al.[2005]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

Despite the UK National Institute of Health and Care Excellence recommending spinal cord stimulation (SCS) for chronic neuropathic pain since 2008, less than 1% of eligible patients received the intervention by 2020.

The number of patients with neuropathic pain increased significantly from 50,288 in 2010-2011 to 66,376 in 2019-2020, yet the uptake of SCS procedures did not show a corresponding increase, indicating a gap between recommendation and actual treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Neuropathic Pain in England From 2010 to 2020: A Hospital Episode Statistics Analysis. Duarte, RV., Nevitt, S., Houten, R., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis. ElSaban, M., Kleppel, DJ., Kubrova, E., et al.[2023]

In a study of 26 patients with chronic pain who underwent spinal cord stimulation, 50% of the patients reported at least 50% relief from their pain during structured interviews.

The evaluation included input from both clinicians and close relatives, highlighting the importance of multiple perspectives in assessing the effectiveness of spinal cord stimulation for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation and the relief of chronic pain. Koeze, TH., Williams, AC., Reiman, S.[2019]

A systematic review identified 22 guideline statements for spinal cord stimulation (SCS) in chronic pain treatment from 1998 to 2013, highlighting a need for improved patient selection and therapy durability.

Current guidelines show significant gaps in coverage and evidence synthesis, indicating that updated and more comprehensive guidelines are necessary to enhance patient outcomes and access to neurostimulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. Deer, TR., Thomson, S., Pope, JE., et al.[2022]

Spinal cord stimulation (SCS) is an invasive treatment option for patients with chronic pain, typically used when other pain management methods have failed.

Recent advancements allow patients to adjust their SCS settings for optimal comfort, highlighting the importance of tailored nursing care and potentially establishing specific care standards for SCS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic intractable pain: nursing implications. Gilbert, M., Counsell, CM., Martin, P., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

10 kHz spinal cord stimulation: a retrospective analysis of real-world data from a community-based, interdisciplinary pain facility. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation 50 Years Later: Clinical Outcomes of Spinal Cord Stimulation Based on Randomized Clinical Trials-A Systematic Review. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. [2005]

7. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Neuropathic Pain in England From 2010 to 2020: A Hospital Episode Statistics Analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation and the relief of chronic pain. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic intractable pain: nursing implications. [2019]