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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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
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 groups in NCT02327325
Study groupRoleWhat they receive
Physical Activity OnlyExperimental12-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 TherapyExperimental12-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 GroupNo interventionWill 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted30 Dec 2014 (estimated)
  2. Study start21 May 2015
  3. Primary completion30 Nov 2016
  4. Study completion1 Mar 2017

Resources

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)
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
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

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.

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