Clinical trial NCT02265848: High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Official title: Single Blinded, Randomized Control Trial of High Frequency Stimulation in Subjects With Precision® Spinal Cord Stimulator System to Assess Efficacy and Preferability in Back and Extremity Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Low Back Pain
Radiculopathy
Complex Regional Pain Syndrome (CRPS)
Keywords: Spinal cord stimulation
Chronic pain
Chronic low back pain
Radiculopathy
Complex Regional Pain Syndrome (CRPS)
High Frequency stimulation
Lead sponsor: The Center for Clinical Research, Winston-Salem, NC
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulator.

Detailed description: Subject with Precision models of spinal cord stimulators will be invited to take part in the study that will compare the high frequency stimulation versus low frequency stimulation to look for any changes in efficacy, and preferability between high and low frequency stimulation program for the spinal cord stimulator (SCS) system.

The study is designed as 7 week study that can take up to 9 weeks per subject. 7 weeks are divided into 3 segments. First segment will be 3 weeks of spinal cord stimulation followed by second segment of wash off period, which will take 1 week (7 days), then the last segment with 3 weeks of spinal cord stimulation. At the end of each segments, there will be a follow up visits.

Each follow up visits can occur up to 5 business days after the follow up due date for post spinal cord stimulation follow ups, and up to 3 business days after the follow up due date for the post wash off visit.

At each visits, including baseline, subject will be asked to answer Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), and Patients Global Impression of Change (PGIC) to assess interval effect of the programming parameter for the spinal cord stimulator.

Visit schedule and assessment summary:

Visit 1: Screening and Baseline

* Review inclusion and exclusionary criteria (I\&E)
* Informed Consent
* Demographics, Medical History
* Physical examination, Vital signs.
* Randomization (A, or B) and programming of devices according to randomization
* Baseline questionnaires
* Numeric Pain Rating Scale (NPRS) to measure the pain experienced by the subject over 1 week prior to enrolling in the study. this will include best pain, worse pain, and average pain as well as pain at the time of enrollment.
* Oswestry disability index (ODI) will measure the average disability caused by the painful condition approximately 3 weeks prior to the enrollment in to the study. Subject will be asked on 10 different categories of activities of daily living. They are: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.
* Patients Global Impression of Change (PGI-C) will be asked to assess the subject's impression of their painful condition, since the implanting of the spinal cord stimulator.
* Concomitant medications

Visit 2: (end of 3 week assessments, + 5 days) End of first treatment period

* Interim Questionnaires:
* NPRS: We will measure pain experienced by the subject over 3 weeks since the last research visit (visit 1),prior to visit 2. This will include best pain, worse pain, and average pain as well as pain at the time of enrollment.
* Oswestry disability index will measure the disability caused by the painful condition since last visit of the study (visit 1), which covers 3 weeks of duration after the last research visit. Subject will be asked on 10 different categories of activities of daily living. They are: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.
* PGI-C will be asked to assess the subject's impression of their painful condition, since the last visit of the study (visit 1), which covers 3 weeks of duration since the last research visit, prior to visit 2.
* Device Interrogation and turn off SCS for 7 to 10 days
* Start wash off period for 7 to 10 days
* Review Adverse Events (AE) and Concomitant medications (Con meds)

Visit 3: (end of wash off period, +3 days) Beginning of second treatment period

* Questionnaires:
* NPRS to measure the pain experienced by the subject over 1 week since visit 2, prior to visit 3, this will include best pain, worse pain, and average pain as well as pain at the time of enrollment.
* Oswestry disability index will measure the disability caused by the painful condition 1 week since last visit 2, prior to the visit 3. Subject will be asked on 10 different categories of activities of daily living. They are: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.
* PGI-C will be asked to assess the subject's impression of their painful condition, during the last 1 week since visit 2, prior to visit 3.
* Device interrogation and programming; start of next treatment period.
* Review AE and Con meds.

Visit 4: (end of 3 week assessment +5 days) End of Treatment

* End of second treatment period.
* End of treatment Questionnaires:
* NPRS: We will measure pain experienced by the subject over 3 weeks since the last research visit (visit 3) prior to visit 4. This will include best pain, worse pain, and average pain as well as pain at the time of enrollment.
* Oswestry disability index will measure the disability caused by the painful condition since last visit of the study, which covers 3 weeks of duration after the last research visit (visit 3). Subject will be asked on 10 different categories of activities of daily living. They are: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.
* PGI-C will be asked to assess the subject's impression of their painful condition, since the last visit of the study, which covers 3 weeks of duration since the last research visit (visit 3), prior to visit 4.
* Device Interrogation and re-programming if necessary.
* Review AE's and Con meds

Eligibility criteria: Inclusion Criteria:

1. Subject must be 18 years and older, and younger than 70 years of age.
2. Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
3. Subject pain scores \>5 on NPRS

Exclusion Criteria:

1. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
2. Unstable medical or psychiatric illness
3. Lifetime history of psychosis, hypomania, or mania.
4. Epilepsy, or dementia
5. Substance abuse in the last 6 months
6. Pregnant or breastfeeding
7. Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
8. Treatment with investigational drug within 30 days of screening.
9. Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Secondary outcomes:
measure: Oswestry Disability Index Questionnaire (ODI).
timeFrame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Other outcomes:
measure: Preferability
timeFrame: End of treatment visit on visit 4
Locations:
city: Winston Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
Study officials:
affiliation: The Carolinas Pain Institute
name: James M North, MD
role: PRINCIPAL_INVESTIGATOR
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