Back PainNCT01976598
Sub-Sensory Intraspinal Neurostimulation Therapy
An observational study of Back Pain and Back Pain With Radiation, run by Algos Clinical Development Thomas L. Yearwood, MD, PhD at 1 site in United States.
Trial summary
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Back Pain With Radiation, Pain in Leg, Unspecified
- What is being tested?
- Sub-Sensory Stimulation
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain
Who may be able to join
- Primary pain complaint of persistent or recurrent low back and/or leg pain, with or without leg pain, for at least 180 days prior to Baseline.
- Received a Boston Scientific SCS System with active contacts located between superior endplate of T7 and the inferior endplate of T10 with a minimum of three active contacts within this anatomical area.
- No back surgery within 180 days prior to Baseline.
- Has had stimulator "on" (activated or operational) for at least 36 hours prior to Baseline evaluation.
- Average low back and/or leg pain intensity, during the position/activity which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale without neurostimulation.
- If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) for 30 days prior to Baseline
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- Consumed an average total daily morphine equivalent of ≤300 mg during the 30 days prior to Baseline
- Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock throughout the study, changes to the stimulation parameters, complete twice-daily diary)
- 22 years of age or older when written informed consent is obtained
- Able to independently read and complete all questionnaires and assessments provided in English
- Subject signed a valid, IRB-approved informed consent form (ICF) provided in English
Who cannot join
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes (e.g. pelvic pain, chronic migraine, schizophrenia)
- Current uncontrolled diabetes mellitus
- Significant cognitive impairment at Baseline that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity and/or complete a pain diary
- Participated in any investigational study within 30 days prior to the Screening Visit or is currently participating in another clinical trial that may influence the data that will be collected for this study
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- Plan to receive any massage or manipulation directly over the leads or by the location of the IPG or treatments that involve sudden jerking motions of the torso at any time during the course of the study
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- Unresolved active litigation related to the pain condition being treated in the study
- Currently involved in a worker's compensation claim
- Unable to operate the SCS System
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, 39581
About this study
Official title: Sub-Sensory Intraspinal Neurostimulation Therapy In the Treatment of Neuropathic Back and/or Leg Pain
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.
Read the detailed description
Chronic pain remains a serious public health problem, resulting in approximately 100 million chronic pain patients in the U.S. alone [1]. While numerous treatments exist, none completely addresses this issue. In particular, spinal cord stimulation (SCS) has become an established technique for treating patients with chronic neuropathic pain [2]. The conventional paradigm for SCS treatment is to attempt to mask the pain by substituting the pain sensation with paresthesias [3]; however, newer studies have shown that it is possible to gain excellent pain relief without concomitant paresthesias ("sub-threshold stimulation") using different stimulation parameters [4] [5]. Because these paresthesia-free programming paradigms are still new, the best to place the stimulation and the best programming parameters to use is still unclear, making it difficult to place the leads during surgical implantation and to program the patient afterwards. Additionally, sub-threshold stimulation does not provide immediate pain relief, but may take several hours or even days to feel relief, making a simple programming session of a few hours insufficient to determine the optimal stimulation placement. While these differences from conventional SCS make programming more difficult initially, studying this new stimulation paradigm, especially differences in optimal stimulation location and the time course of pain relief, may also provide insight into the mechanism of action of sub-threshold stimulation. This protocol aims to study the optimal stimulation parameters and locations with SCS using sub-threshold stimulation.
- Being tested
- Sub-Sensory Stimulation
- Keywords
- chronic, back, leg, pain, sub-sensory, stimulation, Neuromodulation, Yearwood
- Medical subject headings
- Back Pain, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-Sensory StimulationOther
Also called Sub-Sensory Spinal Cord Stimulatiocn.
Sub-Sensory Stimulation using Boston Scientific Spinal Cord Stimulation System in patients currently implanted with the system .
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation: Sub-Sensory | Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain using Sub-Sensory Stimulation. Receives: Other: Sub-Sensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score (VAS)
The primary outcome measure is the final visual analog score (VAS) score obtained using a paper pain diary obtained on the last evening of each program.
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algos Clinical Development Thomas L. Yearwood, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Algos Clinical Development Thomas L. Yearwood, MD, PhD, Algos Clinical Development
- Investigators
- Thomas L Yearwood, MD, PhD, Principal investigator, Algos Cinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976598
- Sponsor's protocol ID
- ALG-ANA1001
- Other IDs
- 20131546
- Status last verified
- Jan 2015
- First submitted
- 30 Oct 2013
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel spinal cord stimulation parameters in patients with predominant back pain. Neuromodulation. 2013 Jul-Aug;16(4):370-5. doi: 10.1111/ner.12032. Epub 2013 Feb 21.
PubMed 23433237
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-Sensory Intraspinal Neurostimulation Therapy In the Treatment of Neuropathic Back and/or Leg Pain
- ClinicalTrials.gov ID
- NCT01976598
- Acronym / sponsor ID
- ALG-ANA1001
- Keywords
- chronic, back, leg, pain, sub-sensory, stimulation, Neuromodulation, Yearwood
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Algos Clinical Development Thomas L. Yearwood, MD, PhDUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.
Detailed description
Chronic pain remains a serious public health problem, resulting in approximately 100 million chronic pain patients in the U.S. alone [1]. While numerous treatments exist, none completely addresses this issue. In particular, spinal cord stimulation (SCS) has become an established technique for treating patients with chronic neuropathic pain [2]. The conventional paradigm for SCS treatment is to attempt to mask the pain by substituting the pain sensation with paresthesias [3]; however, newer studies have shown that it is possible to gain excellent pain relief without concomitant paresthesias ("sub-threshold stimulation") using different stimulation parameters [4] [5]. Because these paresthesia-free programming paradigms are still new, the best to place the stimulation and the best programming parameters to use is still unclear, making it difficult to place the leads during surgical implantation and to program the patient afterwards. Additionally, sub-threshold stimulation does not provide immediate pain relief, but may take several hours or even days to feel relief, making a simple programming session of a few hours insufficient to determine the optimal stimulation placement. While these differences from conventional SCS make programming more difficult initially, studying this new stimulation paradigm, especially differences in optimal stimulation location and the time course of pain relief, may also provide insight into the mechanism of action of sub-threshold stimulation. This protocol aims to study the optimal stimulation parameters and locations with SCS using sub-threshold stimulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation: Sub-Sensory | – | Other: Sub-Sensory StimulationPatients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain using Sub-Sensory Stimulation. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain
Key inclusion criteria (11 listed)
- Primary pain complaint of persistent or recurrent low back and/or leg pain, with or without leg pain, for at least 180 days prior to Baseline.
- Received a Boston Scientific SCS System with active contacts located between superior endplate of T7 and the inferior endplate of T10 with a minimum of three active contacts within this anatomical area.
- No back surgery within 180 days prior to Baseline.
- Has had stimulator "on" (activated or operational) for at least 36 hours prior to Baseline evaluation.
- Average low back and/or leg pain intensity, during the position/activity which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale without neurostimulation.
Key exclusion criteria (9 listed)
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes (e.g. pelvic pain, chronic migraine, schizophrenia)
- Current uncontrolled diabetes mellitus
- Significant cognitive impairment at Baseline that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity and/or complete a pain diary
- Participated in any investigational study within 30 days prior to the Screening Visit or is currently participating in another clinical trial that may influence the data that will be collected for this study
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
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 |
|---|---|---|
| Sub-Sensory StimulationAlso: Sub-Sensory Spinal Cord Stimulatiocn.Sub-Sensory Stimulation using Boston Scientific Spinal Cord Stimulation System in patients currently implanted with the system . | Other | Spinal Cord Stimulation: Sub-Sensory |
Primary outcome
Visual Analog Score (VAS)
Time frame: 32 days
The primary outcome measure is the final visual analog score (VAS) score obtained using a paper pain diary obtained on the last evening of each program.
Results and safety
The study was stopped early (reason given: Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Background: PubMed 23433237Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel spinal cord stimulation parameters in patients with predominant back pain. Neuromodulation. 2013 Jul-Aug;16(4):370-5. doi: 10.1111/ner.12032. Epub 2013 Feb 21.
- Home Page for the Food and Drug Administration (FDA)Link provided by the sponsor.
- WIRB sets the standard in the field of independent ethical review of biomedical research on human subjects.Link provided by the sponsor.
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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.
Thomas L Yearwood, MD, PhD principal investigator
Algos Cinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain and Back Pain With Radiation, run by Algos Clinical Development Thomas L. Yearwood, MD, PhD 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 11 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: stopped early, as of the sponsor's last update on 19 Jan 2015. 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.
Are results available for this study?
The study was stopped early (reason given: Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.). Results are not available in the source record.
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?
Visual Analog Score (VAS) (time frame: 32 days). 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 NCT01976598, which also lists 1 linked publication.
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 19 Jan 2015.