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

Study Overview
=================
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.

Official Title
-----------------
Functional Impact of PENS for 65+ Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Lumbar PENS + General Conditioning and Aerobic Exercise
* Other: Lumbar PENS
* Other: Control Lumbar PENS
* Other: Control PENS + exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Acupuncture