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

Functional Impact of PENS for 65+ Chronic Low Back Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00101387

Enrollment

200

Registered

2005-01-11

Start date

2003-09-30

Completion date

2008-01-31

Last updated

2011-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Aged, Acupuncture

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.

Interventions

OTHERLumbar PENS + General Conditioning and Aerobic Exercise

As above

OTHERLumbar PENS

As above

OTHERControl Lumbar PENS

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

OTHERControl PENS + exercise

as above

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Roland and Morris questionnaire	Baseline, post-intervention, 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026