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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomodulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11) | Week 0, week 5, week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time on the Patient Health Questionnaire -9 (PHQ-9) | Week 0, week 5, week 9 | |
| Change over time on the Generalized Anxiety Disorder - 7 (GAD-7) | Week 0, week 5, week 9 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Marie Nayback-Beebe, PhD, FNP-BC | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 7, 2018 | |
| Unrelease | Yes | |
| Release | Mar 19, 2018 | |
| Reset | Apr 19, 2018 | |
| Release | Jan 30, 2026 | |
| Reset | Feb 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 7, 2018 | Yes | |||
| Mar 19, 2018 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D000698 | Analgesia |
| D004304 | Dosage Forms |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000760 | Anesthesia and Analgesia |
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| 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. |
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| Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5 |
| Week 0, week 5, week 9 |
| Change over time on the Pittsburgh Sleep Quality Index (PSQI) | Week 0, week 5, week 9 |
| Change over time on the Oswestry Disability Questionnaire (ODQ) | Week 0, week 5, week 9 |
| Change over time on the Quality of Life - Health Survey (SF-12) | Week 0, week 5, week 9 |
| Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF) | Week 0, week 5, week 9 |
| 2 questions on treatment perception |
| week 5 |
| Abbreviated acceptability rating profile - modified (AARP) | Acceptability | week 5 |
| Change over time on oral consumption of analgesic medications | Week 0, week 5, week 9 |
| Apr 19, 2018 |
| Jan 30, 2026 | Feb 17, 2026 |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D004364 |
| Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |