A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Neuropathic Pain
- Sponsor
- Oslo University Hospital
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Usual pain intensity in lower extremity(ies)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
Detailed Description
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms. Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies. In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
Investigators
Bård Lundeland
Principal Investigator
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
- •Understand Norwegian or Swedish language (written and spoken).
- •Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)
Exclusion Criteria
- •Opioid dose \> 100 mg morphine equivalents / day
- •Ongoing litigation
- •Mental / psychiatric disorder that may affect treatment
- •Chronic generalized pain
- •Pregnancy
- •Hypersensitivity to local anesthetics
- •Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
- •Laminectomy in or above level for planned epidural access
- •Spine surgery the last 3 months
- •Ongoing medication that affects coagulation or platelet function
Outcomes
Primary Outcomes
Usual pain intensity in lower extremity(ies)
Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
Secondary Outcomes
- Insomnia(Time Frame: Will be measured at the end of each 14-day treatment period)
- EQ-5D index values(Time Frame: Will be measured at the end of each 14-day treatment period)
- EQ-5D self-rated health(Time Frame: Will be measured at the end of each 14-day treatment period)
- Three individually chosen functions that are inhibited by the pain(Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period))
- Patient impression of change(Time Frame: Will be measured at the end of each 14-day treatment period)
- Pain intensity in lower extremity(ies)"now"(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Synptoms of anxiety and depression(Time Frame: Will be measured at the end of each 14-day treatment period)
- Patient blinding questionnaire(Time Frame: Will be measured at the end of each 14-day treatment period)
- Highest pain intensity in lower extremity(ies)(Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Lowest pain intensity in lower extremity(ies)(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Pain unpleasantness(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Usual pain intensity in lower back(Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))