N/A
N=60
Physical Activity for Older Adults Chronic Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02327325 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Sep 2018
Primary outcome: Primary: Timed Get-Up-And Go — -1.84; -2.15; 1.11 seconds — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Activity (Behavioral); Cognitive Behavioral Therapy (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed Get-Up-And Go |
-1.84; -2.15; 1.11 | 0.08 |
| PRIMARY PROMIS Health Assessment Questionnaire |
-2.90; -0.89; 3.21 | 0.07 |
| SECONDARY Patient Specific Functional Scale |
3.72; 3.00; 0.08 | 0.097 |
| SECONDARY Roland-Morris Disease Specific Disability Questionnaire |
-3.21; -1.11; 0.89 | <0.01 sig |
| SECONDARY Satisfaction With Physical Function Scale |
3.11; 3.06; 2.96 | 0.95 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Self-report having had lower back pain on most days for greater than three months.
- Can complete a 10 second semi-tandem stand and walk 8' in 6.0 seconds.
- 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.
- Can safely participate in the intervention based upon the physical therapist baseline examination and clinical expertise.
Exclusion Criteria
- 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);
- dementia or other significant cognitive impairment;
- movement or motor neuron disorders (e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis);
- rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease;
- hospitalization for a stroke, myocardial infarction, heart failure, or coronary artery revascularization in the past 3 months;
- significant hearing impairment (must be able to talk on the telephone);
- psychosis or current, uncontrolled substance abuse disorder;
- any other health conditions determined by the study team to be contraindications to performing mild to moderate home exercises.
Data sourced from ClinicalTrials.gov (NCT02327325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.