Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
Functional Impact of PENS for 65+ Chronic Low Back Pain
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 low-back-pain
Started Sep 2003
Longer than P75 for phase_3 low-back-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 10, 2005
CompletedFirst Posted
Study publicly available on registry
January 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFebruary 18, 2011
February 1, 2011
4.3 years
January 10, 2005
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Roland and Morris questionnaire
Baseline, post-intervention, 6 months
Study Arms (4)
Lumbar PENS + exercise
EXPERIMENTALLumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
Lumbar PENS
ACTIVE COMPARATORLumbar PENS twice a week for 6 weeks
Control PENS
PLACEBO COMPARATORControl lumbar PENS twice a week for 6 weeks
Control PENS + exercise
ACTIVE COMPARATORControl PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
Interventions
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Eligibility Criteria
You may qualify if:
- Low back pain for at least 3 months
- Able to walk without an assistive device (e.g., cane or walker)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra K. Weiner, MD
Pain Evaluation and Treatment Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2005
First Posted
January 11, 2005
Study Start
September 1, 2003
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
February 18, 2011
Record last verified: 2011-02