Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
NCT ID: NCT00101387
Last Updated: 2011-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2003-09-30
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lumbar PENS + exercise
Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
Lumbar PENS + General Conditioning and Aerobic Exercise
As above
Lumbar PENS
Lumbar PENS twice a week for 6 weeks
Lumbar PENS
As above
Control PENS
Control lumbar PENS twice a week for 6 weeks
Control Lumbar PENS
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Control PENS + exercise
Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
Control PENS + exercise
as above
Interventions
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Lumbar PENS + General Conditioning and Aerobic Exercise
As above
Lumbar PENS
As above
Control Lumbar PENS
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Control PENS + exercise
as above
Eligibility Criteria
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Inclusion Criteria
* Able to walk without an assistive device (e.g., cane or walker)
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute on Aging (NIA)
NIH
University of Pittsburgh
OTHER
Responsible Party
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University of Pittsburgh
Principal Investigators
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Debra K. Weiner, MD
Role: PRINCIPAL_INVESTIGATOR
Pain Evaluation and Treatment Institute
Other Identifiers
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