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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biomodulator
Usual Care (Medication + Exercise)
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring back, pain, chronic

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual Care (Medication + Exercise)

Biomodulator + Usual Care

Arm Description

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 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).

Outcomes

Primary Outcome Measures

Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)

Secondary Outcome Measures

Change over time on the Patient Health Questionnaire -9 (PHQ-9)
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
Change over time on the Pittsburgh Sleep Quality Index (PSQI)
Change over time on the Oswestry Disability Questionnaire (ODQ)
Change over time on the Quality of Life - Health Survey (SF-12)
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
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.
Abbreviated acceptability rating profile - modified (AARP)
Acceptability
Change over time on oral consumption of analgesic medications

Full Information

First Posted
January 22, 2014
Last Updated
January 31, 2018
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02707094
Brief Title
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Official Title
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
back, pain, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (Medication + Exercise)
Arm Type
Other
Arm Description
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.
Arm Title
Biomodulator + Usual Care
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Biomodulator
Other Intervention Name(s)
Tennant Biomodulator, Transcutaneous electrical nerve stimulator for pain relief
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care (Medication + Exercise)
Intervention Description
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 Measure Information:
Title
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time Frame
Week 0, week 5, week 9
Secondary Outcome Measure Information:
Title
Change over time on the Patient Health Questionnaire -9 (PHQ-9)
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Oswestry Disability Questionnaire (ODQ)
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Quality of Life - Health Survey (SF-12)
Time Frame
Week 0, week 5, week 9
Title
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
Time Frame
Week 0, week 5, week 9
Title
2 questions on treatment perception
Description
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.
Time Frame
week 5
Title
Abbreviated acceptability rating profile - modified (AARP)
Description
Acceptability
Time Frame
week 5
Title
Change over time on oral consumption of analgesic medications
Time Frame
Week 0, week 5, week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Marie Nayback-Beebe, PhD, FNP-BC
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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