Lower Back PainNCT02421757
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
A study testing Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device in people with Lower Back Pain, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a single-site, randomized, Single-blinded, placebo-controlled, trial of Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be applied locally to the back in the location of a patient's pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2016to 22 Jun 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, age >18 years of age
- Prescription pharmacologic treatment is insufficient for treatment of pain
- Pain duration of ≥ 6 months
- Pain limits physical activity
- Pain occurs daily
- Chronic low back pain, with or without leg pain, associated with MRI or other imaging study consistent with lumbo-sacral spine disease with or without nerve compression
- Pain intensity ≥ 5 at the time of enrollment a a self-reported pain score of ≥ 4 over the 7 preceding days.
Who cannot join
- Life expectancy ≤ 6 months for any reason
- Oral opiate dosing or type of opioid that has changed in past 12 months
- Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months
- Use of intravenous pain medication in the past 6 months
- Active use of a transcutaneous electrical nerve stimulator (TENS) [within 30 days]
- History of seizures
Show all 16Show fewer
- History of implanted medical device, cardiac pacemaker or implantable cardiac defibrillator, or other implant (Cochlear etc)
- History of cardiac dysrhythmias
- Member of vulnerable population
- Current or potential legal action of disability claim related to back pain
- Body Mass Index (BMI) >35
- Another pain condition that might confound results, including back pain above the waistline
- Women of child-bearing potential
- Inability to undergo study assessments or complete questionnaires independently
- Metal objects in the body (i.e. Aneurysm clip, bullet fragment)
- Active psychological co-morbidites (i.e. uncontrolled schizophrenia)
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-site, randomized, Single-blinded, placebo-controlled, trial of Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be applied locally to the back in the location of a patient's pain.
Read the detailed description
Approximately one third of Americans suffer from acute and chronic pain and pain has been called a silent epidemic. Treatment of pain often involves opioid medications with a significant potential for abuse, addiction and adverse reactions such as respiratory depression and death. Magnetic brain stimulation has been used for the treatment of pain. There are reports of its use in phantom-limb pain and in the treatment of central and peripheral pain syndromes.
The study will evaluate whether an experimental medical device (Fischell TCMS Pain Treatment Device) that emits pulses of a brief, intense magnetic field will relieve pain in the lower back. Transcutaneous Magnetic Stimulation (TCMS) is the name of this method of delivering magnetic pulses through the skin. TCMS has been approved by the FDA for peripheral nerve stimulation, treatment of migraine headaches and for depression but this type of device has not been studied scientifically for the treatment of back pain. No significant adverse reactions or side effects have been reported with the use of magnetic stimulation for headache treatment. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they do not get pain relief with medications. Other patients do not have headache relief with magnetic treatment. The current use of TCMS applied to the head requires special equipment and multiple treatment sessions. TCMS applied peripherally is easier to do, and may require fewer treatment sessions to achieve pain relief. Non-invasive treatment of pain would represent a significant advance in the field especially if its use both successfully treated pain and resulted in the reduction or elimination in the need for opioid medications.
The investigators do not know whether magnetic treatment will relieve back pain so the investigators will test this by applying a powerful electromagnet to the area of the back having pain. In some patients, the magnet will be turned on, but in other patients the magnet will not be turned on. Neither patients nor patient's treating doctor will know whether the magnet was turned on or not, although the study team will know which patients received treatment with magnetic pulses. The effect on pain will be recorded periodically for 2 days. If the patients' reported pain is reduced by having the magnet turned on compared to patients' who do not have the magnet turned on, then the magnet may have reduced the pain. Additional studies in patients will be needed to be sure that the magnet therapy is reducing low back pain.
- Conditions
- Lower Back Pain
- Being tested
- Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device, Placebo
- Keywords
- Transcutaneous Magnetic Stimulation, placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fischell Transcutaneous Magnetic Stimulation Pain Treatment DeviceDevice
Transcutaneous Magnetic Stimulation
PlaceboDevice
Also called Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)
The placebo Transcutaneous device
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Magnetic Stimulation | Experimental | Transcutaneous Magnetic Stimulation Receives: Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device |
| Sham Device | Placebo comparator | Sham Device Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)
Immediate relief measured by Numeric Pain Rating Scale (NPRS)
Scale from 0-10 0=No pain 10= Worse possible pain
Measured: 60 minutes
Secondary outcomes (1)
Durable Pain Measured by Numeric Pain Rating Scale (NPRS)
Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start22 Aug 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Rock, University of Maryland, Baltimore
- Investigators
- Peter Rock, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421757
- Sponsor's protocol ID
- HP-00062233
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2015
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
- ClinicalTrials.gov ID
- NCT02421757
- Acronym / sponsor ID
- HP-00062233
- Conditions
- Lower Back Pain
- Keywords
- Transcutaneous Magnetic Stimulation, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-site, randomized, Single-blinded, placebo-controlled, trial of Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be applied locally to the back in the location of a patient's pain.
Detailed description
Approximately one third of Americans suffer from acute and chronic pain and pain has been called a silent epidemic. Treatment of pain often involves opioid medications with a significant potential for abuse, addiction and adverse reactions such as respiratory depression and death. Magnetic brain stimulation has been used for the treatment of pain. There are reports of its use in phantom-limb pain and in the treatment of central and peripheral pain syndromes.
The study will evaluate whether an experimental medical device (Fischell TCMS Pain Treatment Device) that emits pulses of a brief, intense magnetic field will relieve pain in the lower back. Transcutaneous Magnetic Stimulation (TCMS) is the name of this method of delivering magnetic pulses through the skin. TCMS has been approved by the FDA for peripheral nerve stimulation, treatment of migraine headaches and for depression but this type of device has not been studied scientifically for the treatment of back pain. No significant adverse reactions or side effects have been reported with the use of magnetic stimulation for headache treatment. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they do not get pain relief with medications. Other patients do not have headache relief with magnetic treatment. The current use of TCMS applied to the head requires special equipment and multiple treatment sessions. TCMS applied peripherally is easier to do, and may require fewer treatment sessions to achieve pain relief. Non-invasive treatment of pain would represent a significant advance in the field especially if its use both successfully treated pain and resulted in the reduction or elimination in the need for opioid medications.
The investigators do not know whether magnetic treatment will relieve back pain so the investigators will test this by applying a powerful electromagnet to the area of the back having pain. In some patients, the magnet will be turned on, but in other patients the magnet will not be turned on. Neither patients nor patient's treating doctor will know whether the magnet was turned on or not, although the study team will know which patients received treatment with magnetic pulses. The effect on pain will be recorded periodically for 2 days. If the patients' reported pain is reduced by having the magnet turned on compared to patients' who do not have the magnet turned on, then the magnet may have reduced the pain. Additional studies in patients will be needed to be sure that the magnet therapy is reducing low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Magnetic Stimulation | Experimental | Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment DeviceTranscutaneous Magnetic Stimulation |
| Sham Device | Placebo comparator | Device: PlaceboSham Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult, age >18 years of age
- Prescription pharmacologic treatment is insufficient for treatment of pain
- Pain duration of ≥ 6 months
- Pain limits physical activity
- Pain occurs daily
Key exclusion criteria (16 listed)
- Life expectancy ≤ 6 months for any reason
- Oral opiate dosing or type of opioid that has changed in past 12 months
- Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months
- Use of intravenous pain medication in the past 6 months
- Active use of a transcutaneous electrical nerve stimulator (TENS) [within 30 days]
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 |
|---|---|---|
| Fischell Transcutaneous Magnetic Stimulation Pain Treatment DeviceTranscutaneous Magnetic Stimulation | Device | Transcutaneous Magnetic Stimulation |
| PlaceboAlso: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)The placebo Transcutaneous device | Device | Sham Device |
Primary outcome
Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)
Time frame: 60 minutes
Immediate relief measured by Numeric Pain Rating Scale (NPRS) Scale from 0-10 0=No pain 10= Worse possible pain
1 secondary outcome
Durable Pain Measured by Numeric Pain Rating Scale (NPRS)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Peter Rock, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device in people with Lower Back Pain, run by University of Maryland, Baltimore 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 7 inclusion and 16 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 23 Nov 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2021). 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?
Immediate Pain Measured by Numeric Pain Rating Scale (NPRS) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.