High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Condition: Chronic Pain; Low Back Pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS)
MeSH terms: Radiculopathy; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): High frequency stimulation; Low frequency stimulation
Intervention type(s): Other; Other
Intervention description(s): Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz.; Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spinal cord stimulation; Chronic pain; Chronic low back pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS); High Frequency stimulation