Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment bundle.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain, Multidisciplinary Approach, Rehabilitation Exercise, Acceptance & Commitment Therapy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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.
Detailed description
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:
1. 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. 2. 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
Interventions
- Other Treatment bundle
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.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (12)
- 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.]
- 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.]
- 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.]
- Physical function (6-min-walk test) [Time frame: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.]
- Physical function (sit-to-stand test) [Time frame: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.]
- Physical function (stair test) [Time frame: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Department of pain management and research, Oslo university hospital — Oslo
Identifiers
NCT: NCT07403331 · 942321