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Trial record 42 of 46 for:    CYCLOBENZAPRINE

A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02707094
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ann Marie Nayback-Beebe, PhD, RN, Brooke Army Medical Center

Brief 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 Syndrome (PTSD).

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Biomodulator Other: Usual Care (Medication + Exercise) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.
Other: 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.

Experimental: Biomodulator + Usual Care
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).
Device: Biomodulator
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.
Other Names:
  • Tennant Biomodulator
  • Transcutaneous electrical nerve stimulator for pain relief

Other: 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.




Primary Outcome Measures :
  1. Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11) [ Time Frame: Week 0, week 5, week 9 ]

Secondary Outcome Measures :
  1. Change over time on the Patient Health Questionnaire -9 (PHQ-9) [ Time Frame: Week 0, week 5, week 9 ]
  2. Change over time on the Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Week 0, week 5, week 9 ]
  3. Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5 [ Time Frame: Week 0, week 5, week 9 ]
  4. Change over time on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 0, week 5, week 9 ]
  5. Change over time on the Oswestry Disability Questionnaire (ODQ) [ Time Frame: Week 0, week 5, week 9 ]
  6. Change over time on the Quality of Life - Health Survey (SF-12) [ Time Frame: Week 0, week 5, week 9 ]
  7. Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF) [ Time Frame: Week 0, week 5, week 9 ]
  8. 2 questions on treatment perception [ Time Frame: week 5 ]
    1. Did you feel this treatment intervention was a success or failure (select one)? Complete Success Partial Success Partial Failure Complete Failure Explain why.
    2. 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.

  9. Abbreviated acceptability rating profile - modified (AARP) [ Time Frame: week 5 ]
    Acceptability

  10. Change over time on oral consumption of analgesic medications [ Time Frame: Week 0, week 5, week 9 ]


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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707094


Locations
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United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Ann Marie Nayback-Beebe, PhD, FNP-BC Brooke Army Medical Center

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Responsible Party: Ann Marie Nayback-Beebe, PhD, RN, COL, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02707094     History of Changes
Other Study ID Numbers: TSNRP-N12-006
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ann Marie Nayback-Beebe, PhD, RN, Brooke Army Medical Center:
back
pain
chronic
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs