Chronic PainPhase 4HFSCSNCT02265848
High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
A Phase 4 study testing High frequency stimulation and Low frequency stimulation in people with Chronic Pain and Low Back Pain, run by The Center for Clinical Research, Winston-Salem, NC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Low Back Pain, Radiculopathy
- What is being tested?
- High frequency stimulation and Low frequency stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be 18 years and older, and younger than 70 years of age.
- Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- Subject pain scores >5 on NPRS
Who cannot join
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
- Pregnant or breastfeeding
Show all 9Show fewer
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
- Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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 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.
Read the 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
- Being tested
- High frequency stimulation, Low frequency stimulation
- Keywords
- Spinal cord stimulation, Chronic pain, Chronic low back pain, Radiculopathy, Complex Regional Pain Syndrome (CRPS), High Frequency stimulation
- Medical subject headings
- Chronic Pain, Low Back Pain, Radiculopathy, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency stimulationOther
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.
Low frequency stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Active comparator | Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. Receives: Other: High frequency stimulation; Other: Low frequency stimulation |
| Treatment group B | Active comparator | Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. Receives: Other: High frequency stimulation; Other: Low frequency stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
Measured: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Secondary outcomes (2)
Oswestry Disability Index Questionnaire (ODI).
ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
Measured: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Patient's Global Impression of Change (PGIC)
PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.
Measured: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical Research, Winston-Salem, NC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James M North, MD, Principal investigator, The Carolinas Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265848
- Sponsor's protocol ID
- IIR-2014-01
- Acronym
- HFSCS
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2014
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participants data will be shared with anyone other than study staff for analysis purposes.
Publications
Simpson BA. Spinal cord stimulation. Br J Neurosurg. 1997 Feb;11(1):5-11. doi: 10.1080/02688699746627. No abstract available.
PubMed 9156011Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.
PubMed 21528381Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, van den Wildenberg FA. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000 Aug 31;343(9):618-24. doi: 10.1056/NEJM200008313430904.
PubMed 10965008Gordon AT, Zou SP, Kim Y, Gharibo C. Challenges to setting spinal cord stimulator parameters during intraoperative testing: factors affecting coverage of low back and leg pain. Neuromodulation. 2007 Apr;10(2):133-41. doi: 10.1111/j.1525-1403.2007.00101.x.
PubMed 22151862Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: a review of experimental studies. Auton Neurosci. 2008 Feb 29;138(1-2):9-23. doi: 10.1016/j.autneu.2007.11.001.
PubMed 18083639Fisher LE, Tyler DJ, Triolo RJ. Optimization of selective stimulation parameters for multi-contact electrodes. J Neuroeng Rehabil. 2013 Feb 27;10:25. doi: 10.1186/1743-0003-10-25.
PubMed 23442372Guan Y, Wacnik PW, Yang F, Carteret AF, Chung CY, Meyer RA, Raja SN. Spinal cord stimulation-induced analgesia: electrical stimulation of dorsal column and dorsal roots attenuates dorsal horn neuronal excitability in neuropathic rats. Anesthesiology. 2010 Dec;113(6):1392-405. doi: 10.1097/ALN.0b013e3181fcd95c.
PubMed 21068658El-Khoury C, Hawwa N, Baliki M, Atweh SF, Jabbur SJ, Saade NE. Attenuation of neuropathic pain by segmental and supraspinal activation of the dorsal column system in awake rats. Neuroscience. 2002;112(3):541-53. doi: 10.1016/s0306-4522(02)00111-2.
PubMed 12074897Cui JG, O'Connor WT, Ungerstedt U, Linderoth B, Meyerson BA. Spinal cord stimulation attenuates augmented dorsal horn release of excitatory amino acids in mononeuropathy via a GABAergic mechanism. Pain. 1997 Oct;73(1):87-95. doi: 10.1016/s0304-3959(97)00077-8.
PubMed 9414060Cui JG, Meyerson BA, Sollevi A, Linderoth B. Effect of spinal cord stimulation on tactile hypersensitivity in mononeuropathic rats is potentiated by simultaneous GABA(B) and adenosine receptor activation. Neurosci Lett. 1998 May 15;247(2-3):183-6. doi: 10.1016/s0304-3940(98)00324-3.
PubMed 9655623Song Z, Meyerson BA, Linderoth B. The interaction between antidepressant drugs and the pain-relieving effect of spinal cord stimulation in a rat model of neuropathy. Anesth Analg. 2011 Nov;113(5):1260-5. doi: 10.1213/ANE.0b013e3182288851. Epub 2011 Jul 25.
PubMed 21788322Song Z, Meyerson BA, Linderoth B. Spinal 5-HT receptors that contribute to the pain-relieving effects of spinal cord stimulation in a rat model of neuropathy. Pain. 2011 Jul;152(7):1666-1673. doi: 10.1016/j.pain.2011.03.012. Epub 2011 Apr 22.
PubMed 21514998Ding X, Hua F, Sutherly K, Ardell JL, Williams CA. C2 spinal cord stimulation induces dynorphin release from rat T4 spinal cord: potential modulation of myocardial ischemia-sensitive neurons. Am J Physiol Regul Integr Comp Physiol. 2008 Nov;295(5):R1519-28. doi: 10.1152/ajpregu.00899.2007. Epub 2008 Aug 27.
PubMed 18753268Smits H, van Kleef M, Joosten EA. Spinal cord stimulation of dorsal columns in a rat model of neuropathic pain: evidence for a segmental spinal mechanism of pain relief. Pain. 2012 Jan;153(1):177-183. doi: 10.1016/j.pain.2011.10.015. Epub 2011 Nov 9.
PubMed 22078661Prager JP. What does the mechanism of spinal cord stimulation tell us about complex regional pain syndrome? Pain Med. 2010 Aug;11(8):1278-83. doi: 10.1111/j.1526-4637.2010.00915.x.
PubMed 20704677
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02265848
- Acronym / sponsor ID
- HFSCS / IIR-2014-01
- Keywords
- Spinal cord stimulation, Chronic pain, Chronic low back pain, Radiculopathy, Complex Regional Pain Syndrome (CRPS), High Frequency stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Center for Clinical Research, Winston-Salem, NCUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 11 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Active comparator | Other: High frequency stimulation, Other: Low frequency stimulationSubjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
| Treatment group B | Active comparator | Other: High frequency stimulation, Other: Low frequency stimulationSubjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be 18 years and older, and younger than 70 years of age.
- Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- Subject pain scores >5 on NPRS
Key exclusion criteria (9 listed)
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency stimulationImplanted 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. | Other | Treatment group A, Treatment group B |
| Low frequency stimulationImplanted 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. | Other | Treatment group A, Treatment group B |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.
2 secondary outcomes
Oswestry Disability Index Questionnaire (ODI).
Time frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Patient's Global Impression of Change (PGIC)
Time frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9156011Simpson BA. Spinal cord stimulation. Br J Neurosurg. 1997 Feb;11(1):5-11. doi: 10.1080/02688699746627. No abstract available.
- Background: PubMed 21528381Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.
- Background: PubMed 10965008Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, van den Wildenberg FA. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000 Aug 31;343(9):618-24. doi: 10.1056/NEJM200008313430904.
- Background: PubMed 22151862Gordon AT, Zou SP, Kim Y, Gharibo C. Challenges to setting spinal cord stimulator parameters during intraoperative testing: factors affecting coverage of low back and leg pain. Neuromodulation. 2007 Apr;10(2):133-41. doi: 10.1111/j.1525-1403.2007.00101.x.
- Background: PubMed 18083639Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: a review of experimental studies. Auton Neurosci. 2008 Feb 29;138(1-2):9-23. doi: 10.1016/j.autneu.2007.11.001.
- Background: PubMed 23442372Fisher LE, Tyler DJ, Triolo RJ. Optimization of selective stimulation parameters for multi-contact electrodes. J Neuroeng Rehabil. 2013 Feb 27;10:25. doi: 10.1186/1743-0003-10-25.
- Background: PubMed 21068658Guan Y, Wacnik PW, Yang F, Carteret AF, Chung CY, Meyer RA, Raja SN. Spinal cord stimulation-induced analgesia: electrical stimulation of dorsal column and dorsal roots attenuates dorsal horn neuronal excitability in neuropathic rats. Anesthesiology. 2010 Dec;113(6):1392-405. doi: 10.1097/ALN.0b013e3181fcd95c.
- Background: PubMed 12074897El-Khoury C, Hawwa N, Baliki M, Atweh SF, Jabbur SJ, Saade NE. Attenuation of neuropathic pain by segmental and supraspinal activation of the dorsal column system in awake rats. Neuroscience. 2002;112(3):541-53. doi: 10.1016/s0306-4522(02)00111-2.
- Background: PubMed 9414060Cui JG, O'Connor WT, Ungerstedt U, Linderoth B, Meyerson BA. Spinal cord stimulation attenuates augmented dorsal horn release of excitatory amino acids in mononeuropathy via a GABAergic mechanism. Pain. 1997 Oct;73(1):87-95. doi: 10.1016/s0304-3959(97)00077-8.
- Background: PubMed 9655623Cui JG, Meyerson BA, Sollevi A, Linderoth B. Effect of spinal cord stimulation on tactile hypersensitivity in mononeuropathic rats is potentiated by simultaneous GABA(B) and adenosine receptor activation. Neurosci Lett. 1998 May 15;247(2-3):183-6. doi: 10.1016/s0304-3940(98)00324-3.
- Background: PubMed 21788322Song Z, Meyerson BA, Linderoth B. The interaction between antidepressant drugs and the pain-relieving effect of spinal cord stimulation in a rat model of neuropathy. Anesth Analg. 2011 Nov;113(5):1260-5. doi: 10.1213/ANE.0b013e3182288851. Epub 2011 Jul 25.
- Background: PubMed 21514998Song Z, Meyerson BA, Linderoth B. Spinal 5-HT receptors that contribute to the pain-relieving effects of spinal cord stimulation in a rat model of neuropathy. Pain. 2011 Jul;152(7):1666-1673. doi: 10.1016/j.pain.2011.03.012. Epub 2011 Apr 22.
- Individual participant dataSharing planned: No. No individual participants data will be shared with anyone other than study staff for analysis purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M North, MD principal investigator
The Carolinas Pain Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High frequency stimulation and Low frequency stimulation in people with Chronic Pain and Low Back Pain, run by The Center for Clinical Research, Winston-Salem, NC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265848, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.