Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
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Treatments
Details and patient eligibility
About
The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
Full description
After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years or older
- neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
- pre-procedure psychological clearance
Exclusion criteria
- younger than 18 years
- prior neuromodulation including spinal cord stimulation
- prior dorsal root ganglion stimulation
- prior peripheral nervous system stimulation
- anatomical obstacles to dorsal column lead placement
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Julie C McCauley; Roslyn M Kackman
Data sourced from clinicaltrials.gov
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