Improving Function in Elders With Chronic Lower Back Pain
BACKGROUND
For the period of 1991-2002, Medicare data indicates a 132% increase in patients with low back pain (LBP) and a 387% increase in LBP related charges. Musculoskeletal pain, which includes LBP, is a well-documented cause of functional decline and disability in older adults (individuals > 65 years), yet little research has been conducted in this population. With 75% of long term care residents and 50% of community dwelling older adults reporting chronic musculoskeletal pain (Helme et al. 2001), it is necessary for clinicians and researchers to gain a better understanding of this condition. Enhanced understanding may allow the development of effective, cost-conscious intervention strategies.
Assessing physical function in older adults through self-report and performance-based measures is common practice in epidemiology research, yet, less common in clinical practice. Reuben et al reported that the assessment of physical function in older adults is best performed by a combination of self-report instruments and observed measures of physical function (Reuben et al. 1995). Mobility assessment allows corroboration of the individual’s perceived level of function. Researchers have demonstrated that mobility status is predictive of functional decline, mortality, and disability in elderly adults (Guralnik et al. 2000). In older adults with LBP mobility deficits such as decreased walking speed and increased chair rise time are found (Reid et al. 2005). Furthermore, Hicks and colleagues have shown that moderate to severe LBP is associated with functional decline (Hicks et al. 2005).
This study combines self-report assessments and performance measures such as walking speed, stair climbing speed, and time needed to rise from a chair to evaluate individuals with chronic LBP. Chronic LBP is defined as pain in the lower back of greater than 3 months. The study also looks at measures of trunk muscle function in older adults with low back pain using magnetic resonance imaging (MRI) and real-time ultrasound, in an attempt to better understand what is happening at the musculoskeletal level.
DESCRIPTION OF STUDY
Using a randomized controlled trial design (RCT), 62 community dwelling older adults ages 60-85 years with chronic low back pain (LBP), as defined by LBP of greater than 3 months duration, who have never had extensive spinal surgery and have no prominent pain in sites other than the back, will receive one of two interventions: 1) trunk muscle training plus neuromuscular electrical stimulation or 2) massage, modalities, and exercises. Individuals will attend physical therapy 2 times per week for 12 weeks. Prior to initiating treatment (baseline), immediately after the last treatment session (12 weeks post baseline), and 3 months later (6 month post-baseline), subjects will be evaluated by a physical therapist using a variety of assessments designed to record pain level, mood, coping strategies, and physical abilities. Evaluations will also include the use of magnetic resonance imaging and rehabilitative ultrasound to examine muscle composition.
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Exclusion Criteria |
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STAGES OF THE STUDY
PHONE INTERVIEW
Prior to entering into the study, each potential subject will be interviewed by phone by a member of the research team to determine whether he/she meets preliminary criteria for inclusion in the study. He/she shall be given a detailed description of the study and have all questions answered. Should the subject elect to participate, he/she will be mailed a packet of information regarding the study and forms to complete prior to his or her physical therapy evaluation.
If the subject seeks participation without a physician’s referral, the research team will contact the subject's physician for medical clearance .
PHYSICAL THERAPY EVALUATION
Subjects will receive a comprehensive evaluation with no out-of-pocket costs by a licensed physical therapist at the University of Delaware Physical Therapy Clinic. The evaluation will include questions regarding the individuals past medical history, concurrent medical conditions, mental state, pain, and psychosocial function. A battery of physical performance tests will be administered including rising from a chair, walking 10 feet and returning to sit in a chair; walking up and down a flight of stairs; and rotating from side-to-side as quickly as possible while sitting in a chair. The individual will walk across a computerized walkway which will record how he/she walks. Ultrasound will be used to measure trunk muscle size and function while the individual is lifting his/her leg. This session will take 2.5 to 3 hours.
MRI EVALUATION
If the subject passes all criteria and is included in the study, the individual will be requested to undergo an MRI at MRI Consultants at Abby Medical Center by Dr. Philip Chao. This MRI will document the structure of the trunk muscles. Imaging will take about 30 minutes. Subjects will be requested to have a repeat MRI at the conclusion of their physical therapy intervention sessions.
INTERVENTION AND RE-ASSESSMENT
Subjects will be randomly assigned to one of two treatment interventions. For both intervention groups, individuals will be offered treatment twice a week for 12 weeks . Subjects will be reassessed by a physical therapist who is unaware of treatment group assignment immediately after their treatment concludes and 3 months later (6 months after entering the study). Subjects will also be requested to participate in phone interviews at 1 and 2 months after his/her therapy concludes.
CONTACT INFORMATION
Please contact Martha Callahan, research coordinator, if you have further questions or would like to participate in this study. Her contact information is:
Phone: (302) 831-6202
E-mail address: mcall@udel.edu.
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