Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain

February 17, 2011 updated by: University of Pittsburgh

Functional Impact of PENS for 65+ 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar PENS + exercise
Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
Other: Lumbar PENS + General Conditioning and Aerobic Exercise
As above
Active Comparator: Lumbar PENS
Lumbar PENS twice a week for 6 weeks
Other: Lumbar PENS
As above
Placebo Comparator: Control PENS
Control lumbar PENS twice a week for 6 weeks
Other: Control Lumbar PENS
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Active Comparator: Control PENS + exercise
Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise
Other: Control PENS + exercise
as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Roland and Morris questionnaire
Time Frame: Baseline, post-intervention, 6 months
Baseline, post-intervention, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 10, 2005

First Submitted That Met QC Criteria

January 10, 2005

First Posted (Estimate)

January 11, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000985-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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