Clinical trial NCT04708392: Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Official title: Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.

Detailed description: In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.

Eligibility criteria: Inclusion Criteria:

1. Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
2. Patients are \>/= 18 years old at the time of enrollment.
3. Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.

Exclusion Criteria:

1. Patients less than 18 years old.
2. Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.

Primary outcomes:
measure: Quantitative Stimulus Testing (QST)-Thermal
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: McGill Pain Questionnaire (MPQ)
timeFrame: Change from baseline to 4 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: Change from baseline to 4 weeks
measure: Beck's Depression Inventory (BDI)
timeFrame: Change from baseline to 4 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Change from baseline to 4 weeks
measure: Numerical Rating Scale (NRS)
timeFrame: Change from baseline to 4 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Change from baseline to 4 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 4 weeks
measure: Quantitative Stimulus Testing (QST)-Sensitivity
timeFrame: Change from baseline to 4 weeks
measure: Quantitative Stimulus Testing (QST)-Pressure
timeFrame: Change from baseline to 4 weeks
measure: Quantitative Stimulus Testing (QST)-Vibration
timeFrame: Change from baseline to 4 weeks
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: AMC Department of Neurosurgery
name: Julie Pilitsis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
citation: Hou S, Kemp K, Grabois M. A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Neuromodulation. 2016 Jun;19(4):398-405. doi: 10.1111/ner.12440. Epub 2016 May 3.
citation: De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.