Low Back PainPACe-LBPNCT02327325
Physical Activity for Older Adults Chronic Low Back Pain
A study testing Physical Activity and Cognitive Behavioral Therapy in people with Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physical Activity and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2015to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Physical Activity, Cognitive Behavioral Therapy
- Keywords
- Low Back Pain, Exercise, Cognitive Behavioral Therapy, Aged
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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 TherapyBehavioural
Telephone-based training in multiple skills for managing low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Only | Experimental | 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. Receives: Behavioral: Physical Activity |
| Physical Activity + Cognitive Behavioral Therapy | Experimental | 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. Receives: Behavioral: Physical Activity; Behavioral: Cognitive Behavioral Therapy |
| Wait List Control Group | No intervention | Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12-week follow-up
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.
Measured: Change from baseline to 12-week follow-up
Secondary outcomes (3)
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).
Measured: Change from baseline to 12-week follow-up
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.
Measured: Change from baseline to 12-week follow-up
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.
Measured: Change from baseline to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study start21 May 2015
- Primary completion30 Nov 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327325
- Sponsor's protocol ID
- E1569-P
- Acronym
- PACe-LBP
- Status last verified
- Sep 2018
- First submitted
- 8 Dec 2014
- Last updated
- 6 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29669086
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP
- ClinicalTrials.gov ID
- NCT02327325
- Acronym / sponsor ID
- PACe-LBP / E1569-P
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Exercise, Cognitive Behavioral Therapy, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Duke University
- Study start
- 21 May 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 6 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Only | Experimental | Behavioral: Physical Activity12-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 + Cognitive Behavioral Therapy | Experimental | Behavioral: Physical Activity, Behavioral: Cognitive Behavioral Therapy12-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. |
| Wait List Control Group | No intervention | –Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity12-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. | Behavioural | Physical Activity + Cognitive Behavioral Therapy, Physical Activity Only |
| Cognitive Behavioral TherapyTelephone-based training in multiple skills for managing low back pain. | Behavioural | Physical Activity + Cognitive Behavioral Therapy |
Primary outcome
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.
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.
3 secondary outcomes
Patient Specific Functional Scale
Time frame: Change from baseline to 12-week follow-up
Roland-Morris Disease Specific Disability Questionnaire
Time frame: Change from baseline to 12-week follow-up
Satisfaction With Physical Function Scale
Time frame: Change from baseline to 12-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29669086Goode 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Cognitive Behavioral Therapy in people with Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Get-Up-And Go (time frame: Change from baseline to 12-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.