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OpenTrials
Completed

NCT Number: NCT00101387

Effects of Lumbar PENS and Exercise in Older Adults With 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar PENS + General Conditioning and Aerobic Exercise

Other

As above

Lumbar PENS

Other

As above

Control Lumbar PENS

Other

Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.

Control PENS + exercise

Other

as above

Primary outcomes

  1. Roland and Morris questionnaire

    Time frame: Baseline, post-intervention, 6 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute on Aging (NIA)

Registry information

Official study title

Functional Impact of PENS for 65+ Chronic Low Back Pain

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2005
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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