Chronic Low Back PainNCT02707094
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
A study testing Biomodulator in people with Chronic Low Back Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress… Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Biomodulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Aug 2016
- 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 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- active duty Service Members (SMs) between the ages of 18 and 62, inclusive
- history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
- participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
- must be able to speak and read English and understand the study procedures
Who cannot join
- pacemaker or implanted electronic device
- history of stroke, blood clots, or cardiac arrhythmias
- pregnancy
- no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
- open wound over site of chronic pain;
- history of spinal surgery
Show all 11Show fewer
- participation in a clinical trial for an investigational drug/ treatment within last 30 days
- undergone treatment with TENS, biofeedback, or acupuncture within last 30 days
- prior treatment with the Biomodulator
- LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia
- participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).
- Conditions
- Chronic Low Back Pain
- Being tested
- Biomodulator, Usual Care (Medication + Exercise)
- Keywords
- back, pain, chronic
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomodulatorDevice
Also called Tennant Biomodulator, Transcutaneous electrical nerve stimulator for pain relief
The Biomodulator is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. Micro-current levels between 20-500 microampere appear to be most effective at relieving pain and inflammation and promoting tissue healing by realigning the natural electrical balance that exists within the cells that has become disrupted due to injury.
Usual Care (Medication + Exercise)Other
The study LP will prescribe an analgesic medication regimen based on the participant's needs. These medications may consist of Non-steroidal anti-inflammatory Drugs (NSAIDs) (ibuprofen, naproxen sodium, etc.), muscle relaxants (Flexeril, Robaxin, valium, etc.), non-narcotic analgesic medications (acetaminophen, aspirin, tramadol, etc.), or narcotic medications (Tylenol #3, Percocet, Vicodin, etc.) depending on the severity of their pain and co-morbid conditions. The RC will also provide instructions for LBP stretching and strengthening exercises. The following exercises will be recommended as a daily regimen: the partial curl, cat and camel, pelvic tilt, quadriceps, arm/leg raises,trunk rotation, single knee to chest stretch, standing hamstring stretch, and double knee to chest stretch.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Medication + Exercise) | Other | Usual Care: Participants will receive guidance on over-the-counter and prescribed pain medications to use to treat their chronic low back pain symptoms. The Research Coordinator (RC) will provide instructions for low back pain stretching and strengthening exercises. The Licensed Provider (LP) will determine if any exercises should be excluded based on their physical limitations. Participants enrolled in the usual care treatment arm will track the frequency of their back stretching and strengthening exercise sessions on the Pain Medication \& Exercise Diary. For the purpose of this study, treatment compliance will be met if participants complete the exercises a minimum of three times per week. Receives: Other: Usual Care (Medication + Exercise) |
| Biomodulator + Usual Care | Experimental | Biomodulator + Usual Care treatment group: Usual care, as described above, will be provided to all participants randomly allocated to this treatment group, in addition to treatment with the Biomodulator three times per week x 4 weeks. The licensed provider will review medication and treatment logs, prescribe pain medications as indicated, and assess for treatment side effects. In addition to treatment with the Biomodulator, the participant will perform back stretching and core strengthening exercises for a minimum of three times per week as instructed and will be told to use their prescribed pain medications as needed to self-treat their low back pain symptoms (as previously described above). Receives: Device: Biomodulator; Other: Usual Care (Medication + Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
Measured: Week 0, week 5, week 9
Secondary outcomes (10)
Change over time on the Patient Health Questionnaire -9 (PHQ-9)
Measured: Week 0, week 5, week 9
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
Measured: Week 0, week 5, week 9
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
Measured: Week 0, week 5, week 9
Change over time on the Pittsburgh Sleep Quality Index (PSQI)
Measured: Week 0, week 5, week 9
Change over time on the Oswestry Disability Questionnaire (ODQ)
Measured: Week 0, week 5, week 9
Change over time on the Quality of Life - Health Survey (SF-12)
Measured: Week 0, week 5, week 9
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
Measured: Week 0, week 5, week 9
2 questions on treatment perception
- Did you feel this treatment intervention was a success or failure (select one)? Complete Success Partial Success Partial Failure Complete Failure Explain why.
- Did you find it easy or difficult to adhere to the treatment plan (select one)? Very Easy Somewhat Easy Somewhat Difficult Very Difficult Explain why.
Measured: week 5
Abbreviated acceptability rating profile - modified (AARP)
Acceptability
Measured: week 5
Change over time on oral consumption of analgesic medications
Measured: Week 0, week 5, week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ann Marie Nayback-Beebe, PhD, RN, Brooke Army Medical Center
- Investigators
- Ann Marie Nayback-Beebe, PhD, FNP-BC, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707094
- Sponsor's protocol ID
- TSNRP-N12-006
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02707094
- Acronym / sponsor ID
- TSNRP-N12-006
- Conditions
- Chronic Low Back Pain
- Keywords
- back, pain, chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 14 Mar 2016 (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.
The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Medication + Exercise) | Other | Other: Usual Care (Medication + Exercise)Usual Care: Participants will receive guidance on over-the-counter and prescribed pain medications to use to treat their chronic low back pain symptoms. The Research Coordinator (RC) will provide instructions for low back pain stretching and strengthening exercises. The Licensed Provider (LP) will determine if any exercises should be excluded based on their physical limitations. Participants enrolled in the usual care treatment arm will track the frequency of their back stretching and strengthening exercise sessions on the Pain Medication \& Exercise Diary. For the purpose of this study, treatment compliance will be met if participants complete the exercises a minimum of three times per week. |
| Biomodulator + Usual Care | Experimental | Device: Biomodulator, Other: Usual Care (Medication + Exercise)Biomodulator + Usual Care treatment group: Usual care, as described above, will be provided to all participants randomly allocated to this treatment group, in addition to treatment with the Biomodulator three times per week x 4 weeks. The licensed provider will review medication and treatment logs, prescribe pain medications as indicated, and assess for treatment side effects. In addition to treatment with the Biomodulator, the participant will perform back stretching and core strengthening exercises for a minimum of three times per week as instructed and will be told to use their prescribed pain medications as needed to self-treat their low back pain symptoms (as previously described above). |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- active duty Service Members (SMs) between the ages of 18 and 62, inclusive
- history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
- participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
- must be able to speak and read English and understand the study procedures
Key exclusion criteria (11 listed)
- pacemaker or implanted electronic device
- history of stroke, blood clots, or cardiac arrhythmias
- pregnancy
- no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
- open wound over site of chronic pain;
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 |
|---|---|---|
| BiomodulatorAlso: Tennant Biomodulator, Transcutaneous electrical nerve stimulator for pain reliefThe Biomodulator is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. Micro-current levels between 20-500 microampere appear to be most effective at relieving pain and inflammation and promoting tissue healing by realigning the natural electrical balance that exists within the cells that has become disrupted due to injury. | Device | Biomodulator + Usual Care |
| Usual Care (Medication + Exercise)The study LP will prescribe an analgesic medication regimen based on the participant's needs. These medications may consist of Non-steroidal anti-inflammatory Drugs (NSAIDs) (ibuprofen, naproxen sodium, etc.), muscle relaxants (Flexeril, Robaxin, valium, etc.), non-narcotic analgesic medications (acetaminophen, aspirin, tramadol, etc.), or narcotic medications (Tylenol #3, Percocet, Vicodin, etc.) depending on the severity of their pain and co-morbid conditions. The RC will also provide instructions for LBP stretching and strengthening exercises. The following exercises will be recommended as a daily regimen: the partial curl, cat and camel, pelvic tilt, quadriceps, arm/leg raises,trunk rotation, single knee to chest stretch, standing hamstring stretch, and double knee to chest stretch. | Other | Biomodulator + Usual Care, Usual Care (Medication + Exercise) |
Primary outcome
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time frame: Week 0, week 5, week 9
10 secondary outcomes
Change over time on the Patient Health Questionnaire -9 (PHQ-9)
Time frame: Week 0, week 5, week 9
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Week 0, week 5, week 9
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
Time frame: Week 0, week 5, week 9
Change over time on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0, week 5, week 9
Change over time on the Oswestry Disability Questionnaire (ODQ)
Time frame: Week 0, week 5, week 9
Change over time on the Quality of Life - Health Survey (SF-12)
Time frame: Week 0, week 5, week 9
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
Time frame: Week 0, week 5, week 9
2 questions on treatment perception
Time frame: week 5
Abbreviated acceptability rating profile - modified (AARP)
Time frame: week 5
Change over time on oral consumption of analgesic medications
Time frame: Week 0, week 5, week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- 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.
Ann Marie Nayback-Beebe, PhD, FNP-BC principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomodulator in people with Chronic Low Back Pain, run by Brooke Army Medical Center 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 4 inclusion and 11 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 5 Feb 2018. 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?
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11) (time frame: Week 0, week 5, week 9). 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 5 Feb 2018.