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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment bundle | Experimental | Treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity in the lower back | 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) |
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Inclusion criteria:
Peripheral neuropathic pain in one or both legs for >6 months due to:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Ekholdt, PhD-student | Contact | +4723026161 | chrekh@ous-hf.no | |
| Lars-Petter Granan, Ph.D | Contact | +4723026161 | largra@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Lars-Petter Granan, Ph.D | Department of pain management and research, Oslo university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of pain management and research, Oslo university hospital | Recruiting | Oslo | Norway |
Individual participant data for all collected variables, generated during the study and fully documented in an accompanying data dictionary (detailing variable names, codes, values, units, and derivations), will be made available upon reasonable request from qualified researchers after publication Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority.
Direct and indirect identifiers-including names, exact dates, and other re-identification risks-will be systematically removed or transformed (such as index-adjusting dates to retain intervals while preventing linkage), ensuring the dataset supports robust secondary analyses while upholding participant privacy.
The study protocol is planned to be published.
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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.
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|
| 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) | 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). | 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) | 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). | 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) | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Physical function (sit-to-stand test) | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Physical function (stair test) | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Physical activity (MET-minutes per week) | 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. | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Health-related quality of life (EQ-5D index) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Health-related quality of life (EQ-5D-5L VAS) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Depression symptoms (PROMIS-29) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Social participation (PROMIS-29) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Fatigue (PROMIS-29) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Sleep disturbance (PROMIS-29) | 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). | From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation. |
| Opioid and Analgesic Use | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Return to work | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Fear of movement (Tampa Scale) | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Patient-specific functioning | 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). | Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| Patient satisfaction | Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved"). | End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation. |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D012046 | Rehabilitation |
| D064869 | Acceptance and Commitment Therapy |
| D015928 | Cognitive Behavioral Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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