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Optimizing Treatment for Chronic Neuropathic Pain: A Replicated Single Case Experimental Design Evaluating a Treatment Bundle Consisting of Multidisciplinary Rehabilitation and Spinal Cord Stimulation (SCS-R)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 investigatyors 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Norway
Department of pain management and research, Oslo university hospital
RECRUITING
Oslo
Contact Information
Primary
Christopher Ekholdt, PhD-student
chrekh@ous-hf.no
+4723026161
Backup
Lars-Petter Granan, Ph.D
largra@ous-hf.no
+4723026161
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 10
Treatments
Experimental: Treatment bundle
Treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov