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Effects of Electrical Acupuncture and Exercise in Older Adults with Chronic Low Back Pain - Article


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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.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

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

Further Study Details: 

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

Lori G. Thiry      412-665-8052 

Pennsylvania
      Pain Evaluation and Treatment Institute, Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting
Lori G. Thiry  412-665-8052 
Haley Hepner  412-665-8050 
Debra K. Weiner, MD,  Principal Investigator

Study chairs or principal investigators

Debra K. Weiner, MD,  Principal Investigator,  Pain Evaluation and Treatment Institute   

More Information

Study ID Numbers:  AT000985-01A2
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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Page Updated: September 6, 2005
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