Sacral Nerve Root Cysts |
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Clinical Trial: Effects of Electrical Acupuncture and Exercise in Older Adults with Chronic Low Back Pain
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Low Back Pain | Procedure: Percutaneous electrical nerve stimulation (PENS) Behavior: General conditioning and aerobic exercise (GCAE) | Phase III |
MedlinePlus related topics: Back Pain
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Functional Impact of PENS for 65+ Chronic Low Back Pain
Expected Total Enrollment: 200
Study start: September 2003; Expected completion: May 2007
Last follow-up: May 2007; Data entry closure: May 2007
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.
Eligibility
Ages Eligible for Study: 65 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Pennsylvania
Pain Evaluation and Treatment Institute, Pittsburgh, Pennsylvania, 15206, United States; Recruiting
Haley Hepner 412-665-8050
Debra K. Weiner, MD, Principal Investigator
Debra K. Weiner, MD, Principal Investigator, Pain Evaluation and Treatment Institute
More Information
Record last reviewed: January 2005
Last Updated: January 10, 2005
Record first received: January 10, 2005
ClinicalTrials.gov Identifier: NCT00101387
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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