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An Integrated Intervention of Spinal Cord Stimulation and Multidisciplinary Rehabilitation for Chronic Neuropathic Leg Pain: A Single-case Experimental Design Protocol

RecruitingNAAges 18 Years - 60 YearsAllOslo University Hospital
NCT07403331 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Treatment bundle
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Where

1 site
Department of pain management and research, Oslo university hospital
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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