Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
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: Spinal Cord Stimulation Device.
- Who it may be relevant to
- Registry conditions: Complex Regional Pain Syndromes. Basic parameters: from 18 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
- United States
- 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
Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Overview
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.
Detailed 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.
Interventions
- Device Spinal Cord Stimulation Device
The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases.
Primary outcome measures
- Change in Complex Regional Pain Syndrome Severity Scores [Time frame: Baseline, 7 day trial period, 3 months, 6 months]
- Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device [Time frame: 7 day trial period, 3 months, and 6 months.]
Secondary outcome measures (10)
- Change in Prolactin Levels [Time frame: Baseline, 7 day trial period, and 3 months]
- Visual Analogue Pain Scale [Time frame: Baseline, 7 day trial period, 3 months, and 6 months]
- Quality of Life Questionnaire [Time frame: Baseline, 7 day trial period, 3 months, and 6 months]
- Patient Reported Outcomes Measurement Information System-29 v 2.1 [Time frame: Baseline, 7 day trial period, 3 months, and 6 months]
- General Anxiety Disorder-7 [Time frame: Baseline, 7 day trial period, 3 months and 6 months.]
- Patient Health Questionnaire-9 [Time frame: Baseline, 7 day trial period, 3 months, 6 months]
- Short-Form McGill Pain Questionnaire-2 [Time frame: Baseline, 7 day trial period, 3 months, 6 months]
- Pain Catastrophizing Scale [Time frame: Baseline, 7 day trial period, 3 months, 6 months]
- Patient Global Impression of Change [Time frame: 7 day trial period, 3 months and 6 months]
- Amount of Pain Medication Consumed by Patient [Time frame: Baseline, 7 day trial period, 3 months and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Scripps Clinic Torrey Pines — La Jolla
Identifiers
NCT: NCT06421350 · 24-8347