Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.

NCT07403331 | Recruiting

• 1 other identifier: 942321
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Multidisciplinary Approach; Rehabilitation Exercise; Acceptance & Commitment Therapy; Spinal Cord Stimulation (SCS)

Outcome Measures

Primary Outcomes (2)

• Pain intensity in leg(s)

  Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for leg pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .

  From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

• Physical function (PROMIS-29)

  Assessed using the PROMIS-29 Physical Function domain T-score (mean 50, SD 10 in the reference population). Higher scores indicate better physical function. MCID: increase of ≥5 T-score points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .

  From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

Secondary Outcomes (18)

• Pain intensity in the lower back

  From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

• Pain interference (PROMIS-29)

  From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

• Pain intensity (PROMIS-29)

  From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

• Physical function (6-min-walk test)

  Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

• Physical function (sit-to-stand test)

  Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Study Arms (1)

Treatment bundle

EXPERIMENTAL

Treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation

Other: Treatment bundle

Interventions

Treatment bundle OTHER

The intervention is a treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation. The multidisciplinary rehabilitation consists of excercise therapy, cognitive therapy and individualized programming of the SCS device.

Also known as: Spinal cord stimulation, Rehabilitation, Excercise therapy, Acceptance and commitment therapy, Cognitive therapy, Physiotherapy

Treatment bundle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of pain management and research, Oslo university hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Spinal Cord Stimulation; Rehabilitation; Acceptance and Commitment Therapy; Cognitive Behavioral Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lars-Petter Granan, Ph.D

  Department of pain management and research, Oslo university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Ekholdt, PhD-student

CONTACT

+4723026161; chrekh@ous-hf.no

Lars-Petter Granan, Ph.D

CONTACT

+4723026161; largra@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Department for pain management and research. Ph.D.

Model Details: The study examines a treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation. The study uses a single-case experimental design (SCED) ,based on N-of-1 trials: each participant acts as their own control. A long baseline period with many measurement points establishes a stable baseline. The same is done during the intervention, and at 6-month followup. This structure is repeated across10 participants, and combine individual effects to estimate a pooled treatment effect while keeping within-person precision. Timepoint for intervention start is randomized (wait time from when the SCS-system is implanted to the start of the treatment (SCS+rehabilitation), creating a multiple-baseline design to strengthen causal inference. See the Study destription for details. There is no separate control group; each participant's baseline serves as the comparison. SCEDs suit this study because the intervention is complex, and because chronic pain also is complex.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)