Low Back Pain
Conditions
Keywords
Low Back Pain, Exercise, Cognitive Behavioral Therapy, Aged
Brief 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.
Detailed description
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.
Interventions
12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Telephone-based training in multiple skills for managing low back pain.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Get-Up-And Go | Change from baseline to 12-week follow-up | This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Greater number of seconds is associated with poorer physical function. Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function. |
| PROMIS Health Assessment Questionnaire | Change from baseline to 12-week follow-up | Self-reported physical function/disability measure that captures both activities of daily living and instrumental activities of daily living. It consists of 20-items scored on a 0-3 scale with a summed 0-100-unit scale. Higher scores are associated with worse function. Therefore a positive change score indicates worsening over time; negative change score (e.g., lower score at follow-up) indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Functional Scale | Change from baseline to 12-week follow-up | This measure captures items that are specific functional tasks that may be missed on standardized questionnaires. The measure consists of 3 items specifically provided by the patient. Each item provided by the patient is score from a 0 (Unable to perform task) to 10 (able to complete the activity without difficulty) scale. Higher change scores from baseline to follow up indicate more improvement (total range 0-30). |
| Roland-Morris Disease Specific Disability Questionnaire | Change from baseline to 12-week follow-up | 24-item self-report measure of low back pain-specific disability. Higher scores indicate worse function, with a range of 0=no disability to 24=maximum disability measured by the scale. Therefore a positive change score indicates worsening. A negative change score (e.g., lower score at follow-up) indicates improvement. |
| Satisfaction With Physical Function Scale | Change from baseline to 12-week follow-up | This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying. All items are rated on a 7-point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). A positive change score indicates improvement, and a negative change score indicates worsening. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Only 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity. | 20 |
| Physical Activity + Cognitive Behavioral Therapy 12-week combined home-based physical activity and cognitive behavioral program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive physical activity program including stretching, strengthening and aerobic activity. Cognitive behavioral component includes training in multiple skills for managing pain.
Physical Activity: 12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain. | 20 |
| Wait List Control Group Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Excluded by Study Team | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 4 |
Baseline characteristics
| Characteristic | Physical Activity Only | Physical Activity + Cognitive Behavioral Therapy | Wait List Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 3.5 | 69.5 years STANDARD_DEVIATION 4 | 71.9 years STANDARD_DEVIATION 6.5 | 70.3 years STANDARD_DEVIATION 4.9 |
| Education Level At least some college | 13 Participants | 10 Participants | 8 Participants | 31 Participants |
| Education Level High school or technical school | 7 Participants | 10 Participants | 12 Participants | 29 Participants |
| Employment Status Disabled | 7 Participants | 8 Participants | 6 Participants | 21 Participants |
| Employment Status Other | 13 Participants | 12 Participants | 14 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 20 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Household Financial Status Low income | 4 Participants | 6 Participants | 6 Participants | 16 Participants |
| Household Financial Status Other | 16 Participants | 13 Participants | 13 Participants | 42 Participants |
| Marital Status Married | 9 Participants | 13 Participants | 16 Participants | 38 Participants |
| Marital Status Other | 11 Participants | 7 Participants | 4 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | 9 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 19 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 | 1 / 20 |
Outcome results
PROMIS Health Assessment Questionnaire
Self-reported physical function/disability measure that captures both activities of daily living and instrumental activities of daily living. It consists of 20-items scored on a 0-3 scale with a summed 0-100-unit scale. Higher scores are associated with worse function. Therefore a positive change score indicates worsening over time; negative change score (e.g., lower score at follow-up) indicates improvement.
Time frame: Change from baseline to 12-week follow-up
Population: 18 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Only | PROMIS Health Assessment Questionnaire | -2.90 units on a scale |
| Physical Activity + Cognitive Behavioral Therapy | PROMIS Health Assessment Questionnaire | -0.89 units on a scale |
| Wait List Control Group | PROMIS Health Assessment Questionnaire | 3.21 units on a scale |
Timed Get-Up-And Go
This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Greater number of seconds is associated with poorer physical function. Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function.
Time frame: Change from baseline to 12-week follow-up
Population: The analysis populations includes all participants except for one who was unable to stand without assistance and declined to perform this test at both baseline and follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Only | Timed Get-Up-And Go | -1.84 seconds |
| Physical Activity + Cognitive Behavioral Therapy | Timed Get-Up-And Go | -2.15 seconds |
| Wait List Control Group | Timed Get-Up-And Go | 1.11 seconds |
Patient Specific Functional Scale
This measure captures items that are specific functional tasks that may be missed on standardized questionnaires. The measure consists of 3 items specifically provided by the patient. Each item provided by the patient is score from a 0 (Unable to perform task) to 10 (able to complete the activity without difficulty) scale. Higher change scores from baseline to follow up indicate more improvement (total range 0-30).
Time frame: Change from baseline to 12-week follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Only | Patient Specific Functional Scale | 3.72 units on a scale |
| Physical Activity + Cognitive Behavioral Therapy | Patient Specific Functional Scale | 3.00 units on a scale |
| Wait List Control Group | Patient Specific Functional Scale | 0.08 units on a scale |
Roland-Morris Disease Specific Disability Questionnaire
24-item self-report measure of low back pain-specific disability. Higher scores indicate worse function, with a range of 0=no disability to 24=maximum disability measured by the scale. Therefore a positive change score indicates worsening. A negative change score (e.g., lower score at follow-up) indicates improvement.
Time frame: Change from baseline to 12-week follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Only | Roland-Morris Disease Specific Disability Questionnaire | -3.21 units on a scale |
| Physical Activity + Cognitive Behavioral Therapy | Roland-Morris Disease Specific Disability Questionnaire | -1.11 units on a scale |
| Wait List Control Group | Roland-Morris Disease Specific Disability Questionnaire | 0.89 units on a scale |
Satisfaction With Physical Function Scale
This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying. All items are rated on a 7-point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). A positive change score indicates improvement, and a negative change score indicates worsening.
Time frame: Change from baseline to 12-week follow-up
Population: 6 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Only | Satisfaction With Physical Function Scale | 3.11 units on a scale |
| Physical Activity + Cognitive Behavioral Therapy | Satisfaction With Physical Function Scale | 3.06 units on a scale |
| Wait List Control Group | Satisfaction With Physical Function Scale | 2.96 units on a scale |