Physical Activity for Older Adults Chronic Low Back Pain



Status:Completed
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:65 - Any
Updated:9/8/2018
Start Date:May 21, 2015
End Date:March 1, 2017

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Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP

Chronic low back pain (cLBP) is one of the most common and disabling conditions among US
military Veterans. Although physical activity can improve cLBP outcomes, the majority of
Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can
help older Veterans with cLBP to increase their physical activity and improve associated
outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk
for functional limitations. The proposed project will be a pilot study of a telephone-based
physical activity program or physical activity combined with cognitive behavioral pain
management for older adult Veterans with cLBP. Older Veterans are of particular interest
because prior studies of physical activity for cLBP have not addressed this vulnerable
patient group. This study will also inform the VA about whether certain patients with cLBP,
who have greater pain sensitivity, may benefit from other treatment to supplement a physical
activity program.

Chronic low back pain (cLBP) is one of the most common and disabling conditions among US
military Veterans, and the prevalence is rising even more rapidly than other chronic
conditions such as diabetes and hypertension. Studies have shown that physical activity (PA)
can improve outcomes in patients with cLBP, but a major gap in this research is the lack of
studies focusing on older adults; patient samples have been primarily middle-aged and have
included few patients' age 65 years. Therefore, the investigators' lack an evidence base for
the feasibility and effectiveness of PA interventions in this vulnerable group of patients
with cLBP. This is particularly important given the accumulating evidence showing that older
adults with cLBP have significant lower extremity functional limitations, resulting in
difficulty performing necessary daily tasks. Another area of limited investigation among
older adults with cLBP is whether there is added benefit of incorporating cognitive
behavioral therapy for pain management (CBT-P) skills with PA interventions. CBT-P can help
to restructure pain perception and improve pacing of PA. Some patients with cLBP do not
respond favorably to isolated PA interventions, and it is possible that heightened pain
sensitization may underlie this lack of response in some patients. Since CBT-P has been shown
to alter pain processing, older adults with cLBP who have greater pain sensitization may
respond better to a program that combines PA and CBT-P (vs. PA alone); however, this has not
been studied. This information has practical implications for a larger trial to determining
whether a subset of patients with greater central pain sensitivity may need additional
intervention to supplement a PA program.

The investigators will conduct a pilot study of a 12-week home-based PA and PA + CBT-P
programs, both with weekly telephone support, compared with a waiting list control group.
Participants will be 60 older Veterans (age 65) with cLBP. Enrollment of participants will
occur via referrals from geriatric and primary care clinics at the Durham VAMC. The PA
program will be comprehensive, including stretching, strengthening, and aerobic activities,
and the specific types and intensities of the activities will be geared toward older adults.
The CBT-P program will include five different skills, woven into the telephone-based
sessions, with specific application to PA and cLBP. Both interventions will be jointly
delivered by a physical therapist and exercise counselor, who has complementary areas of
expertise (e.g., training in clinical exercise prescription and motivational interviewing
skills to encourage PA adherence, respectively). Telephone calls will involve
patient-specific goal-setting and address barriers to PA and CBT-P skills. Participants will
receive a booklet with instructions and photographs for stretching and strengthening
exercises, as well as an exercise video appropriate for older adults with cLBP. Participants
in the combined intervention will also receive written and audio instructions regarding CBT-P
skills. Feasibility measures will include the proportion of completed intervention calls,
adherence to home-based PA recommendations and CBT-P skills use, and participant feedback on
the programs. Outcomes will be assessed at baseline and 12-week follow-up. Primary measures
of efficacy will be assessments of general physical function, both objective and
self-reported (PROMIS Health Assessment Questionnaire). Secondary outcomes will include
measures cLBP-specific pain and disability. Central pain sensitivity will be assessed via
Pain Pressure Threshold (PPT) testing and the Central Sensitization Inventory (CSI).
Statistical analyses will include comparison of baseline and follow-up outcomes across study
groups, as well as examination of potential trends for differential intervention response
according to baseline PPT and CSI scores.

Inclusion Criteria:

1. Self-report having had lower back pain on most days for greater than three months.

2. Can complete a 10 second semi-tandem stand and walk 8' in 6.0 seconds.

3. Report they are not satisfied with their current state of functional ability, based on
reporting "dissatisfied" with at least one aspect of physical function on the
Satisfaction with Physical Function Scale.

4. Can safely participate in the intervention based upon the physical therapist baseline
examination and clinical expertise.

Exclusion Criteria:

1. unilateral or bilateral sciatica that physical therapist determines could make the
study intervention unsafe or inappropriate; isolated coccyx pain (based on self-report
at screener);

2. dementia or other significant cognitive impairment;

3. movement or motor neuron disorders (e.g., Parkinson's Disease, Multiple Sclerosis,
Amyotrophic Lateral Sclerosis);

4. rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease;

5. hospitalization for a stroke, myocardial infarction, heart failure, or coronary artery
revascularization in the past 3 months;

6. significant hearing impairment (must be able to talk on the telephone);

7. psychosis or current, uncontrolled substance abuse disorder;

8. any other health conditions determined by the study team to be contraindications to
performing mild to moderate home exercises.
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: Kelli Dominick Allen, PhD
Phone: (919) 286-6936
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mi
from
Durham, NC
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