Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain

Stopped early · Phase 1

Conditions studied: Low Back Pain

In brief

The purpose of this research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low intensity treadmill walking exercise. Preliminary data regarding subject compliance, self-report of function, pain control, ambulatory activity, and exercise capacity will be collected to assess the response to this combined acupuncture/treadmill exercise protocol. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.

Key facts

Study ID

NCT00502619

Run by

VA Maryland Health Care System

People needed

10

Starts

2007-09-01

Expected to finish

2010-01-01

Last updated by the study team

2011-08-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veterans eligible for this study are men or women between 25 and 65 years old with non-malignant low back pain greater than 6 months duration and pain scores greater than 4 (on a Numeric Pain Scale of 0 = No Pain and 10 = Worst Imaginable Pain) on most days out of the preceding month.
• Eligible subjects will also need to be able to tolerate 3 minutes walking at a rate of 0.5 miles per hour on a horizontal surface.

You may not qualify if…

• Inability to provide informed consent
• Diagnosis of dementia
• Severe depression (Beck Depression Inventory score > 30), suicidality, or untreated mental illness
• Severe anxiety (Beck Anxiety Inventory score > 30)
• Evidence of current substance abuse or alcoholism on the TICS
• Ongoing litigation related to the low back pain complaint
• Pregnancy or intent to become pregnant during time of study
• Ambulation requiring an assistive device
• Neurological, orthopedic, or other conditions impairing ambulation that would affect exercise safety
• Progressive neurological changes, altered sensation, or a history of cauda equina syndrome
• Pain below the knee that limits ambulation
• Lower extremity amputation proximal to the toes
• Low back pain problem requiring surgical intervention or impending surgery
• A history of lumbar vertebral fracture; and
• A history of prior lumbar surgery. Additional exclusion criteria include medical conditions that would affect an exercise program, such as rheumatologic, infectious, cardiac, peripheral vascular and pulmonary conditions, or ongoing cancer treatment.

Where it is running

• Baltimore VAMC — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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