High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Back Pain, Chronic Pain, Chronic Pain, Chronic Pain, Neurology, Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | January 2015 |
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 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.
stimulation programming of the spinal cord stimulator for subjects who already have a spinal
cord stimulator.
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
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
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
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