Clinical trial NCT06421350: Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Official title: Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in Complex Regional Pain Syndrome Severity Scores
timeFrame: Baseline, 7 day trial period, 3 months, 6 months
measure: Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
timeFrame: 7 day trial period, 3 months, and 6 months.
Secondary outcomes:
measure: Change in Prolactin Levels
timeFrame: Baseline, 7 day trial period, and 3 months
measure: Visual Analogue Pain Scale
timeFrame: Baseline, 7 day trial period, 3 months, and 6 months
measure: Quality of Life Questionnaire
timeFrame: Baseline, 7 day trial period, 3 months, and 6 months
measure: Patient Reported Outcomes Measurement Information System-29 v 2.1
timeFrame: Baseline, 7 day trial period, 3 months, and 6 months
measure: General Anxiety Disorder-7
timeFrame: Baseline, 7 day trial period, 3 months and 6 months.
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 7 day trial period, 3 months, 6 months
measure: Short-Form McGill Pain Questionnaire-2
timeFrame: Baseline, 7 day trial period, 3 months, 6 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 7 day trial period, 3 months, 6 months
measure: Patient Global Impression of Change
timeFrame: 7 day trial period, 3 months and 6 months
measure: Amount of Pain Medication Consumed by Patient
timeFrame: Baseline, 7 day trial period, 3 months and 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
Study officials:
affiliation: Physician
name: David B Hiller, MD
role: PRINCIPAL_INVESTIGATOR
References: