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Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Trunk Muscle Training+NMES
Passive control intervention
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 64 participants > age 65 will be recruited to participate. Participants will be included if they meet the following criteria:

- Low Back Pain for at least 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification. This criterion is necessary to guarantee a subject population that has chronic pain that is not controlled with conventional therapy. At least moderate pain intensity (> 3 on a scale of 0-10) will be required to ensure our ability to detect treatment effects, and because pain of moderate intensity has been shown to be significant in the pain literature.11 The Pain thermometer has been shown to be reliable in older adults12, 13, will be used to screen pain intensity.

Exclusion Criteria:

  • Exclusion Criteria: Subjects will be excluded from the study if any of the following exist:

    • Prominent component of radicular pain: CLBP with distal radiation below the knee
    • Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine) In these other cases, LBP may be of non-mechanical origin.
    • Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker): Since measurement of physical performance in the proposed study includes gait velocity and standing balance, conditions other than LBP that could negatively impact these measures may confound our study results.
    • Folstein Mini-Mental State Examination score of < 24 will exclude subjects because of the uncertain reliability of their answers to the self-reported outcome measures.
    • Severe visual or hearing impairment: Since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection.
    • Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae. These subjects will be promptly referred to their primary practitioners.
    • Significant pain in parts of the body other than the back or acute LBP: Since we will be specifically evaluating chronic LBP, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with LBP severity that is greater than pain severity elsewhere in the body will be included.
    • Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study.
    • Presence of a pacemaker: Since electrical stimulation will be used in this study and the effects of that stimulation on pacemakers is unknown, we will be cautious and exclude subjects with this device.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Trunk Muscle Training+NMES

    Passive control intervention

    Arm Description

    Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals

    Passive physical therapy interventions, including moist heat, ultrasound, massage and flexibility exercises

    Outcomes

    Primary Outcome Measures

    Timed Up and Go
    timed performance test

    Secondary Outcome Measures

    Gait speed
    Oswestry Low Back Pain Disability Questionnaire
    Global Rating of Functional Improvement

    Full Information

    First Posted
    June 28, 2012
    Last Updated
    September 20, 2016
    Sponsor
    University of Delaware
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01632618
    Brief Title
    Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain
    Official Title
    Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Delaware

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all visits to physicians for LBP involve individuals over 65. In older adults, LBP has been associated with a host of negative consequences, including decreased physical function, increased fall risk, increased mood disturbance and increased health care utilization. Surprisingly, little research has focused on LBP in people over 65. But, recent evidence demonstrates that LBP is associated with increased intramuscular fat infiltration in the abdominal and paraspinal muscles and that this altered muscle composition increases the risk of mobility-related functional decline in older adults. While trunk muscle training (TMT) has been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to substantially improve function and symptoms, given the compromised state of ages muscle. TMT augmented with neuromuscular electrical stimulation (NMES) known to improve strength and function beyond the capacity of volitional exercise alone, may provide greater improvements. Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized as a way to prevent functional decline and frailty progression; however this hypothesis has yet to be experimentally confirmed. In this exploratory study, the investigators will test the hypothesis that TMT plus NMES will result in reduced disability and pain severity compared to usual care in elders with chronic LBP.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trunk Muscle Training+NMES
    Arm Type
    Experimental
    Arm Description
    Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals
    Arm Title
    Passive control intervention
    Arm Type
    Active Comparator
    Arm Description
    Passive physical therapy interventions, including moist heat, ultrasound, massage and flexibility exercises
    Intervention Type
    Behavioral
    Intervention Name(s)
    Trunk Muscle Training+NMES
    Intervention Description
    Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals
    Intervention Type
    Behavioral
    Intervention Name(s)
    Passive control intervention
    Intervention Description
    Passive physical therapy approach to low back pain
    Primary Outcome Measure Information:
    Title
    Timed Up and Go
    Description
    timed performance test
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Gait speed
    Time Frame
    6 months
    Title
    Oswestry Low Back Pain Disability Questionnaire
    Time Frame
    6 months
    Title
    Global Rating of Functional Improvement
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 64 participants > age 65 will be recruited to participate. Participants will be included if they meet the following criteria: - Low Back Pain for at least 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification. This criterion is necessary to guarantee a subject population that has chronic pain that is not controlled with conventional therapy. At least moderate pain intensity (> 3 on a scale of 0-10) will be required to ensure our ability to detect treatment effects, and because pain of moderate intensity has been shown to be significant in the pain literature.11 The Pain thermometer has been shown to be reliable in older adults12, 13, will be used to screen pain intensity. Exclusion Criteria: Exclusion Criteria: Subjects will be excluded from the study if any of the following exist: Prominent component of radicular pain: CLBP with distal radiation below the knee Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine) In these other cases, LBP may be of non-mechanical origin. Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker): Since measurement of physical performance in the proposed study includes gait velocity and standing balance, conditions other than LBP that could negatively impact these measures may confound our study results. Folstein Mini-Mental State Examination score of < 24 will exclude subjects because of the uncertain reliability of their answers to the self-reported outcome measures. Severe visual or hearing impairment: Since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection. Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae. These subjects will be promptly referred to their primary practitioners. Significant pain in parts of the body other than the back or acute LBP: Since we will be specifically evaluating chronic LBP, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with LBP severity that is greater than pain severity elsewhere in the body will be included. Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study. Presence of a pacemaker: Since electrical stimulation will be used in this study and the effects of that stimulation on pacemakers is unknown, we will be cautious and exclude subjects with this device.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory E Hicks, PT, PhD
    Organizational Affiliation
    University of Delaware
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain

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