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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.
'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.
The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.
The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burst SCS | Experimental | Burst Spinal cord stimulation. SCS system implanted and burst stimulation given |
|
| Sham SCS | Sham Comparator | Sham spinal cord stimulation. SCS system implanted but no stimulation given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burst Spinal Cord Stimulation | Procedure | Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode |
| Measure | Description | Time Frame |
|---|---|---|
| change in disease-specific functional outcome from baseline | measured with version 2.0 of the Oswestry disability index (ODI) that has been translated into Norwegian and tested for psychometric properties. The ODI questionnaire quantifies disability for degenerative conditions of the lumbar spine and covers intensity of pain, ability to lift, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in generic health-related quality of life measured with the Euro-Qol-5D (5L) | 12 months | |
| Change in back pain | measured using numerical rating scales (NRS) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sasha Gulati, md prof | Contact | +47 73592020 | sasha.gulati@ntnu.no | |
| Sven M Carlsen, md prof | Contact | +47 91769528 | sven.carlsen@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Sasha Gulati, md prof | St. Olavs Hospital | Principal Investigator |
| Geir Bråthen, md prof | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Recruiting | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| 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 |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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During the 12 months following implantation of a spinal cord stimulation (SCS) system, the patients will undergo four three-month long periods with either burst SCS or no stimulation (sham) in a randomized order. All patients will undergo two periods of SCS and sham stimulation.
| Sham spinal cord stimulation | Procedure | No spinal cord stimulation is provided |
|
| SCS implant | Device | a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead |
|
| change in leg pain | measured using numerical rating scales (NRS) | 12 months |
| Daily physical activity | measured by use of a body-worn accelerometer (activPALs from PAL Technologies Ltd., Glasgow, United Kingdom) attached by a waterproof tape to the midpoint of the patients' anterior right thigh | 12 months |
| Six-month follow-up of pain-related disability | Back pain-related disability, leg pain, back pain, and health-related quality of life at 6 months following completion of the final randomization period when patients are unblinded and provided with handheld spinal cord stimulation programmers allowing changes to stimulation settings and switching between burst and tonic stimulation. Measured with version 2.0 of the Oswestry disability index (ODI), leg pain NRS, back pain NRS, Euro-Qol 5D | 18 months |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |