Physical Activity for Older Adults Chronic Low Back Pain (PACe-LBP)

• ClinicalTrials.gov Identifier: NCT02327325
• Recruitment Status: Completed
• First Posted: December 30, 2014
• Results First Posted: September 6, 2018
• Last Update Posted: September 6, 2018
• Sponsor: VA Office of Research and Development
• Collaborator: Duke University
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Physical Activity; Behavioral: Cognitive Behavioral Therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP
• Actual Study Start Date: May 21, 2015
• Actual Primary Completion Date: November 30, 2016
• Actual Study Completion Date: March 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Behavioral: Cognitive Behavioral Therapy; Telephone-based training in multiple skills for managing low back pain.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Timed Get-Up-And Go [ Time Frame: 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.
2. PROMIS Health Assessment Questionnaire [ Time Frame: 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 Outcome Measures :

1. Patient Specific Functional Scale [ Time Frame: 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).
2. Roland-Morris Disease Specific Disability Questionnaire [ Time Frame: 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.
3. Satisfaction With Physical Function Scale [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

VA Office of Research and Development

Duke University

Investigators

• Principal Investigator: Kelli Dominick Allen, PhD; Durham VA Medical Center, Durham, NC

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] September 19, 2016

More Information

Publications of Results:

Goode AP, Taylor SS, Hastings SN, Stanwyck C, Coffman CJ, Allen KD. Effects of a Home-Based Telephone-Supported Physical Activity Program for Older Adult Veterans With Chronic Low Back Pain. Phys Ther. 2018 May 1;98(5):369-380. doi: 10.1093/ptj/pzy026.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02327325
• Other Study ID Numbers: E1569-P
• First Posted: December 30, 2014
• Results First Posted: September 6, 2018
• Last Update Posted: September 6, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Low Back Pain; Exercise; Cognitive Behavioral Therapy; Aged

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations