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NCT Number: NCT07403331

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

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.

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Key information

Conditions

Neuropathic Pain Acceptance & Commitment Therapy Multidisciplinary Approach Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rehabilitation Exercise Signs and Symptoms Spinal Cord Stimulation (SCS)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Single-case experimental design (SCED) with repeated measurements structured into phases is the method of this study.

Phase A1 is the pre-implantation baseline, Phase A2 is waiting time from implantation to start of the intervention (SCS+rehabilitation). Length of A2 is randomized (2-4 weeks).

Phase B is the active SCS+rehabilitation intervention and lasts for 12 weeks (for analysis split into an early B1 (week 1-5) and a later B2 period (week 8-12), and FU is the 5 week follow-up approximately 6 months after implantation.

Outcomes are measured repeatedly within these phases, allowing within-patient phase contrasts.

In general, baseline (A1) is compared with the intervention periods (B1 and B2) and with follow-up (FU). The main pre-specified contrasts for the primary outcomes are:

  • For leg pain intensity A1 vs B1 is the primary comparison and A1 vs B2 is secondary, with A1 vs FU and B2 vs FU reported descriptively.
  • For physical function (PROMIS-29), A1 vs B2 is the primary comparison as onset of rehabilitation effect is expected to be delayed. A1 vs B1 is exploratory, with A1 vs FU and B2 vs FU reported descriptively.

Other repeated-measures outcomes (PROMIS-29 domains and additional NRS/physical activity measures) follow the same structure, with A1 vs B2 generally defined as secondary and A1 vs FU descriptive as shown in the statistical tables

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Spinal cord stimulation, Rehabilitation, Excercise therapy, Acceptance and commitment therapy, Cognitive therapy, Physiotherapy

Primary outcomes

  1. Pain intensity in leg(s)

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

    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) .

  2. Physical function (PROMIS-29)

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

    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) .

Secondary outcomes

  1. Pain intensity in the lower back

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

    Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for lower back 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)

  2. Pain interference (PROMIS-29)

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

    Assessed using the PROMIS-29 Pain Interference domain T-score. Higher scores indicate more interference of pain with daily activities. Improvement is defined as a decrease of ≥5 T-score points (MCID).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  3. Pain intensity (PROMIS-29)

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

    Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for pain intensity last 7 days in PROMIS-29, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points.

    Assessed at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  4. Physical function (6-min-walk test)

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

    Functional walking capacity is assessed using the Six-Minute Walk Test (6MWT). Distance walked in 6 minutes on a flat course is recorded in meters; higher distances indicate better walking capacity.

    Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  5. Physical function (sit-to-stand test)

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

    Lower limb functional strength and endurance are assessed with a Sit-to-Stand Test, recorded as number of repetitions in a fixed time. More repetitions indicate better performance. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  6. Physical function (stair test)

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

    Functional mobility is assessed using a Stair test (ST; time to climb 18 stairs 3 times; lower times indicate better function).

    Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  7. Physical activity (MET-minutes per week)

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

    Physical activity is assessed as metabolic equivalent (MET) minutes per week, calculated from reported frequency and duration of activities (International Physical Activity Questionnaire (IPAQ)). Higher values indicate greater weekly physical activity.

    Assessed once per week during baseline (A1), SCS+rehabilitation (B1/B2), and follow-up (FU) within the single-case experimental design.

  8. Health-related quality of life (EQ-5D index)

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

    EQ-5D-5L index score (range 0-1; higher scores indicate better health-related quality of life).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  9. Health-related quality of life (EQ-5D-5L VAS)

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

    EQ-5D Visual Analogue Scale (EQ-5D VAS; 0-100; higher scores indicate better health-related quality of life).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  10. Depression symptoms (PROMIS-29)

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

    PROMIS Depression scale (T-score; mean 50, SD 10 in U.S. population; higher scores indicate greater symptom severity). Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  11. Social participation (PROMIS-29)

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

    PROMIS Ability to Participate in Social Roles and Activities short form, reported as a T-score (higher scores indicate better function). MCID: increase of ≥5 T-score points.

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  12. Fatigue (PROMIS-29)

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

    Assessed using the PROMIS-29 Fatigue domain T-score. Higher scores indicate greater fatigue. Improvement is defined as a decrease of ≥5 T-score points (MCID).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  13. Sleep disturbance (PROMIS-29)

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

    Assessed using the PROMIS-29 Sleep Disturbance domain T-score. Higher scores indicate more sleep problems. Improvement is defined as a decrease of ≥5 T-score points (MCID).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  14. Opioid and Analgesic Use

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

    Total opioid consumption quantified as milligrams of oral morphine equivalents (OMEQ) per day; non-opioid analgesics quantified in milligrams per day per medication.

    Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  15. Return to work

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

    Return to work status, quantified as hours worked per week (higher values indicate greater work participation).

    Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  16. Fear of movement (Tampa Scale)

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

    Fear of movement is assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement. Improvement is defined as a decrease of >6 points.

    Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).

  17. Patient-specific functioning

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

    Patient-Specific Functional Scale (PSFS), up to five activities selected in cooperation with personnel, rated 0-10 (higher scores indicate better function; average score reported).

    Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).

  18. Patient satisfaction

    Time frame: End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

    Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Ekholdt, PhD-student

CONTACT

[email protected]

+4723026161

Lars-Petter Granan, Ph.D

CONTACT

[email protected]

+4723026161

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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)

Acronym: SCS-R

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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