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

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute on Aging (NIA)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00101387
First received: January 10, 2005
Last updated: February 17, 2011
Last verified: February 2011
History of Changes

January 10, 2005
February 17, 2011
September 2003
January 2008   (final data collection date for primary outcome measure)
Roland and Morris questionnaire [ Time Frame: Baseline, post-intervention, 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00101387 on ClinicalTrials.gov Archive Site
Not Provided
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Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
Functional Impact of PENS for 65+ Chronic Low Back Pain

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Other: Lumbar PENS + General Conditioning and Aerobic Exercise
    As above
  • Other: Lumbar PENS
    As above
  • Other: Control Lumbar PENS
    Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
  • Other: Control PENS + exercise
    as above
  • Experimental: Lumbar PENS + exercise
    Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
    Intervention: Other: Lumbar PENS + General Conditioning and Aerobic Exercise
  • Active Comparator: Lumbar PENS
    Lumbar PENS twice a week for 6 weeks
    Intervention: Other: Lumbar PENS
  • Placebo Comparator: Control PENS
    Control lumbar PENS twice a week for 6 weeks
    Intervention: Other: Control Lumbar PENS
  • Active Comparator: Control PENS + exercise
    Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
    Intervention: Other: Control PENS + exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00101387
R01 AT000985-01A2, R01AT000985-01A2
Yes
Christine Crawford, University of Pittsburgh
University of Pittsburgh
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • National Institute on Aging (NIA)
Principal Investigator: Debra K. Weiner, MD Pain Evaluation and Treatment Institute
University of Pittsburgh
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP