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Chronic PainNCT04708392

Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

A study testing Spinal Cord Stimulator in people with Chronic Pain, run by Albany Medical College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Spinal Cord Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
29 Jul 2017to 11 Sep 2018
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
  • Patients are >/= 18 years old at the time of enrollment.
  • Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.

Who cannot join

  • Patients less than 18 years old.
  • Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albany Medical Center

    Albany, New York, 12208

Other trials in United States

About this study

This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.

Read the detailed description

In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.

Conditions
Chronic Pain
Being tested
Spinal Cord Stimulator
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord StimulatorDevice

    A spinal cord stimulator is a surgically implanted device that delivers an electrical signal to a patient's spinal cord to reduce the perception of pain

Study groups in NCT04708392
Study groupRoleWhat they receive
Tonic spinal cord stimulationExperimentalPatients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.
Receives: Device: Spinal Cord Stimulator
Burst spinal cord stimulationExperimentalPatients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.
Receives: Device: Spinal Cord Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative Stimulus Testing (QST)-Thermal

    Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.

    Measured: Change from baseline to 4 weeks

Secondary outcomes (10)

  1. McGill Pain Questionnaire (MPQ)

    This outcome measurement tool contains 15 descriptive words (11 sensory and 4 affective) used by subjects to describe their pain. Total number of words chosen is documented

    Measured: Change from baseline to 4 weeks

  2. Oswestry Disability Index (ODI)

    This measurement tool assesses functional outcome for 10 conditions in subjects with chronic pain. Patients select a statement for each condition that most closely resembles their own situation. Each statement has a score of 0-5, depending on the severity of the particular disability. Raw scores are calculated into a disability percentage.

    Measured: Change from baseline to 4 weeks

  3. Beck's Depression Inventory (BDI)

    This is a 21 section multiple-choice self-report survey. Patients select a statement in each section that most closely resembles their own situation. Each statement has a score of 0-3, depending on the severity of the depressive content. Raw scores are tallied.

    Measured: Change from baseline to 4 weeks

  4. Pain Catastrophizing Scale (PCS)

    This is a 13 question survey. It is used to assess the degree to which patients ruminate on, magnify, and/or amplify their pain symptoms. Patients rate on a scale of 0-4 (never - all the time) how often they have each of the thoughts listed. Raw scores are tallied

    Measured: Change from baseline to 4 weeks

  5. Numerical Rating Scale (NRS)

    Patients rate, on a scale of 0-10, their pain at it's least, most, and average over the past week. They also rate their pain "right now" as well as their perception of Global Improvement.

    Measured: Change from baseline to 4 weeks

  6. Epworth Sleepiness Scale (ESS)

    This survey is used to assess the 'daytime sleepiness' of patients. Patients rate the likelihood of falling asleep during several daytime scenarios, on a scale of 0-3 (never - very likely). Raw scores are tallied.

    Measured: Change from baseline to 4 weeks

  7. Insomnia Severity Index (ISI)

    This survey is designed to assess the nature, severity, and impact of insomnia in adults. Patients are asked to rate on a scale of 0-4 (no problem - very much a problem) how much of a problem they have with several sleep conditions. Raw scores are tallied.

    Measured: Change from baseline to 4 weeks

  8. Quantitative Stimulus Testing (QST)-Sensitivity

    Von Frey fibers are used to determine tactile sensitivity.

    Measured: Change from baseline to 4 weeks

  9. Quantitative Stimulus Testing (QST)-Pressure

    An algometer is used to measure pain related to pressure.

    Measured: Change from baseline to 4 weeks

  10. Quantitative Stimulus Testing (QST)-Vibration

    A tuning fork is used to measure sensitivity to vibration.

    Measured: Change from baseline to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start29 Jul 2017
  3. Primary completion31 Jul 2018
  4. Study completion11 Sep 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708392
Sponsor's protocol ID
Burst 682552
Status last verified
Jan 2021
First submitted
7 Jul 2020
Last updated
15 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.

    PubMed 28961366

  • Hou S, Kemp K, Grabois M. A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Neuromodulation. 2016 Jun;19(4):398-405. doi: 10.1111/ner.12440. Epub 2016 May 3.

    PubMed 27139915

  • De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.

    PubMed 23321375

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulator in people with Chronic Pain, run by Albany Medical College 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 2 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 15 Jan 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Quantitative Stimulus Testing (QST)-Thermal (time frame: Change from baseline to 4 weeks). 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 NCT04708392, which also lists 3 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 15 Jan 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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