Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisci… (NCT07403331) | Clinical Trial Compass
RecruitingNot Applicable
Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.
Norway10 participantsStarted 2026-05-04
Plain-language summary
People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve.
The investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery.
Previous research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain.
There has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Peripheral neuropathic pain in one or both legs for \>6 months due to:
* (1) Post Spinal Pain Syndrome (type 1 or 2).
* (2) Localized nerve damage.
* The area of the neuropathic pain in the leg(s) must be the dominant pain component.
* Age ranges from 18-60 years.
* Previous standard conservative (or surgical) treatment attempted.
* Opioid use within permissible limits at implantation time (daily opioid dose \<50 mg OMEQ).
* Willingness to actively participate in the treatment bundle.
* Living within reasonable travelling distance from Oslo.
* Proficiency in understanding oral and written Norwegian, essential to benefit from the program that relies on mutual comprehension, nuanced conversation, and emotional expression, which are language-dependent.
* Cognitive capacity to provide informed consent.
* Ability to master the technical aspects of the SCS system (switching programs on the remote control).
Exclusion criteria:
* Currently undergoing the claims process for health benefits (e.g., disability pensions from NAV (Norwegian Labour and Welfare Administration).
* Presenting a psychological or psychiatric disorder that may impact treatment efficacy.
* Chronic generalized pain conditions.
* Other pain conditions in the affected area, such as osteoarthritis.
* Pregnancy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity in leg(s)
Timeframe: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
2
Physical function (PROMIS-29)
Timeframe: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.