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Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lumbar PENS + General Conditioning and Aerobic Exercise
Lumbar PENS
Control Lumbar PENS
Control PENS + exercise
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Aged, Acupuncture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Low back pain for at least 3 months Able to walk without an assistive device (e.g., cane or walker) Exclusion Criteria: Serious underlying illness causing back pain Nerve root compression History of back surgery Has pacemaker Current use of blood thinners Major psychiatric disorder Chest pains or heart problems that interfere with daily activity Fibromyalgia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    Lumbar PENS + exercise

    Lumbar PENS

    Control PENS

    Control PENS + exercise

    Arm Description

    Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise

    Lumbar PENS twice a week for 6 weeks

    Control lumbar PENS twice a week for 6 weeks

    Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise

    Outcomes

    Primary Outcome Measures

    Roland and Morris questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    January 10, 2005
    Last Updated
    February 17, 2011
    Sponsor
    University of Pittsburgh
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00101387
    Brief Title
    Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
    Official Title
    Functional Impact of PENS for 65+ Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.
    Detailed Description
    Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP. Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumbar PENS + exercise
    Arm Type
    Experimental
    Arm Description
    Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
    Arm Title
    Lumbar PENS
    Arm Type
    Active Comparator
    Arm Description
    Lumbar PENS twice a week for 6 weeks
    Arm Title
    Control PENS
    Arm Type
    Placebo Comparator
    Arm Description
    Control lumbar PENS twice a week for 6 weeks
    Arm Title
    Control PENS + exercise
    Arm Type
    Active Comparator
    Arm Description
    Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
    Intervention Type
    Other
    Intervention Name(s)
    Lumbar PENS + General Conditioning and Aerobic Exercise
    Intervention Description
    As above
    Intervention Type
    Other
    Intervention Name(s)
    Lumbar PENS
    Intervention Description
    As above
    Intervention Type
    Other
    Intervention Name(s)
    Control Lumbar PENS
    Intervention Description
    Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Control PENS + exercise
    Intervention Description
    as above
    Primary Outcome Measure Information:
    Title
    Roland and Morris questionnaire
    Time Frame
    Baseline, post-intervention, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Low back pain for at least 3 months Able to walk without an assistive device (e.g., cane or walker) Exclusion Criteria: Serious underlying illness causing back pain Nerve root compression History of back surgery Has pacemaker Current use of blood thinners Major psychiatric disorder Chest pains or heart problems that interfere with daily activity Fibromyalgia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Debra K. Weiner, MD
    Organizational Affiliation
    Pain Evaluation and Treatment Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain

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