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

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Other: Lumbar PENS; Other: Control Lumbar PENS; Other: Lumbar PENS + General Conditioning and Aerobic Exercise; Other: Control PENS + exercise

• Registration Number: NCT00101387
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-01-10
• Study First Submitted QC: 2005-01-10
• Study First Posted: 2005-01-11
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar PENS	Lumbar PENS	Lumbar PENS twice a week for 6 weeks
Control PENS	Control Lumbar PENS	Control lumbar PENS twice a week for 6 weeks
Lumbar PENS + exercise	Lumbar PENS + General Conditioning and Aerobic Exercise	Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise
Control PENS + exercise	Control PENS + exercise	Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise

Primary Outcome Measures

Name	Time	Method
Roland and Morris questionnaire	Baseline, post-intervention, 6 months