Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain
TerminatedPhase 1NCT00502619
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Pilot Study to Determine the Efficacy and Feasibility of a Structured Acupuncture and Treadmill Program to Treat Chronic Low Back Pain Patients to Improve Function, Exercise Capacity, and Pain Control.
- Conditions
- Interventions
- Procedure: Acupuncture
- Other: Treadmill Exercise
- Sponsor
- VA Maryland Health Care System
- Collaborators
- Samueli Institute for Information Biology
- Start date
- 2007-09
- Primary completion
- 2010-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00502619