Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain
|ClinicalTrials.gov Identifier: NCT00502619|
Recruitment Status : Terminated (Inadequate recruitment of study subjects and inadequate retention.)
First Posted : July 17, 2007
Last Update Posted : August 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Acupuncture Other: Treadmill Exercise||Phase 1|
Chronic non-malignant low back pain (CLBP) is very common. It is treated with diverse pharmacological and non-pharmacological therapies, including complementary and alternative pain treatments. Acupuncture has gained increasing acceptance among patients in the United States; however, the efficacy and duration of benefit of acupuncture treatments is often unknown, and prolonged utilization of these treatments is expensive. Successful acupuncture may provide an alternative to pain medications. Randomized studies have shown that exercise can produce long term benefits for individuals experiencing CLBP. Studies have also shown that acupuncture may be useful for the treatment of CLBP.
The purpose of the proposed research is to conduct a study to determine the feasibility of a larger efficacy study of acupuncture to decrease pain and facilitate exercise and function in Veterans with chronic low back pain (CLBP), in a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS). To test this novel approach, subjects will undergo 16 weeks of treatment, consisting of acupuncture for 4 weeks followed by an overlapping period of 12 weeks of acupuncture plus low intensity treadmill walking exercise. Preliminary data will be collected to assess the improvement, if any, of: a) self-report of function, b) pain control, c) ambulatory activity, and d) exercise capacity. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.
Major objectives are to determine the rates of compliance for participation in this therapy of acupuncture plus low-intensity treadmill walking program, the completion rate of all treatment sessions and associated health assessment forms, as well as the challenges of recruitment. In addition, preliminary data to support the application for the larger pilot study will be obtained. The investigators' long-term research goal is to study this novel paradigm and its ability to reduce chronic low back pain.
The specific aims of the study are as follows:
Specific Objective 1. To determine whether individuals with CLBP receiving acupuncture plus treadmill exercise will exhibit superior improvement in function measured by Oswestry Disability Index II.
Specific Objective 2. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will exhibit reduced pain scores measured by the Numeric Pain Intensity Rating Scale.
Specific Objective 3. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will have improved home and community based ambulatory activity levels quantified by Step Activity Monitors (SAM).
Specific Objective 4. CLBP patients receiving acupuncture plus exercise will have greater gains in cardiovascular fitness levels measured by exercise testing with open circuit spirometry (V02 Max).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: Acupuncture plus Treadmill Exercise
Acupuncture plus Treadmill Exercise
A specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks.Other: Treadmill Exercise
After the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments.
- Primary outcome measures are: (1) Numeric Pain Scale, (2) Oswestry Disability Index II, (3) fitness level determined by treadmill exercise, and (4) free-range ambulatory activity using step activity monitors. [ Time Frame: 16 weeks ]
- Self-reports, including function, depression, anxiety, and sleep; a physical performance test battery. [ Time Frame: 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502619
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Robert A Lavin, M.D.||VA Maryland Health Care System|