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

University of Pittsburgh

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Other: Control Lumbar PENS; Other: Lumbar PENS; Other: Lumbar PENS + General Conditioning and Aerobic Exercise; Other: Control PENS + exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00101387

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

Lumbar PENS + exercise

Experimental group

Description:

Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise

Treatment:

Other: Lumbar PENS + General Conditioning and Aerobic Exercise

Lumbar PENS

Active Comparator group

Description:

Lumbar PENS twice a week for 6 weeks

Treatment:

Other: Lumbar PENS

Control PENS

Placebo Comparator group

Description:

Control lumbar PENS twice a week for 6 weeks

Treatment:

Other: Control Lumbar PENS

Control PENS + exercise

Active Comparator group

Description:

Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise

Treatment:

Other: Control PENS + exercise