The Association of Breathing Pattern Dysfunction and Low Back Pain Presentation and Outcomes Following Physical Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in baseline value of breath-by-breath gas analysis
Study Overview
Brief Summary
The goal of this study is to identify if there is a significant prevalence of abnormal respiratory patterns in a sample of patients with low back pain (LBP), and if the presence of abnormal respiratory patterns are predictive of rehabilitation outcomes in this population. In addition, the investigators will assess the response to inspiratory muscle training (IMT) for a subgroup of subjects that maintain abnormal breathing patterns after 1 month of physical therapy. Patients seeking physical therapy for LBP within the Uhealth system will be recruited. The first phase of this study will be observational. A comprehensive assessment of their respiratory function will be performed at the beginning of their therapy and after 1 month of therapy. Subjects that demonstrate abnormal respiratory patterns after 1 month of therapy will be offered the opportunity to participate in the second phase of the study in which they will receive 1 month of inspiratory muscle training (IMT). The respiratory assessment will then be repeated at the end of the IMT training program.
Detailed Description
The purpose of the first stage of this study is to assess the association and prognostic value of respiratory variables to low back pain presentation and outcomes with standard physical therapy care. Thus, a prospective longitudinal cohort, observational repeated measures (pre and post testing), design will be used for this portion of the study. Both the treating physical therapist and the patient will be blinded to the findings of the respiratory assessment in order to minimize the risk of treatment bias. Further, the physical therapy plan of care and the interventions administered will be at the therapists' discretion and will not be standardized. Typically a multimodal treatment approach is used for LBP, which includes: patient education, therapeutic exercises to improve strength, flexibility, and motor control deficits, manual therapy to decrease pain and improve joint and soft tissue mobility, and physical agents for pain management. By allowing therapists to use their clinical judgment, we are maintaining a real world environment which improves generalizability of the results. Although this will introduce variability that may confound results, there is no evidence that any single treatment approach is superior for addressing all LBP patients. Thus, allowing therapists to use their clinical reasoning to subgroup and treat accordingly maintains the standard of practice for all patient care.
A sample of convenience, consisting of 75 consecutive subjects seeking physical therapy for low back pain, will be selected. These subjects will be measured at the initiation of their physical therapy program and then retested 1 month later, using the procedures described below. Subjects with unresolved BPD's at the time of reassessment will be offered the opportunity to receive 1 month of inspiratory muscle training (IMT), which will be the second phase of this study. Subjects that complete the IMT will be retested following the same protocol at the end of the IMT program. All subject
recruitment and data collection will occur through UM facilities, but faculty at Nova Southeastern University will be involved with data analysis. Thus, IRB approval will be obtained from the University of Miami with a reliance agreement with Nova Southeastern University. It is anticipated that data collection will last from 6/2015-6/2016.
RESEARCH DESIGN AND METHODS
Subject recruitment
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18-65,
- •seeking physical therapy services for lumbar or pelvic pain will be recruited for this study.
- •Subjects must intend to complete their prescribed physical therapy plan of care.
Exclusion Criteria
- •Patients unable to consent, complete questionnaires independently, or fulfill all testing requirements will be excluded from the study.
- •All vulnerable populations will be excluded including:
- •prisoners,
- •children,
- •terminally ill patients, and
- •individuals with cognitive, emotional, or communication impairments that require them to have a guardian.
Arms & Interventions
Inspiratory Muscle Training
Subjects will receive 8 weeks of IMT
Intervention: Inspiratory muscle training (Other)
Outcomes
Primary Outcomes
Change in baseline value of breath-by-breath gas analysis
Time Frame: baseline, after 1 month of therapy, after 2 months of IMT
Measure of breathing pattern and respiratory gases at rest and with activity
Secondary Outcomes
- Number of Participants improved on the Oswestry Disability Index(baseline, after 1 month of therapy, after 2 months of IMT)
- Number of Participants improved on the Numeric Pain Rating Scale(baseline, after 1 month of therapy, after 2 months of IMT)
- Change in baseline value of Maximal inspiratory pressure(baseline, after 1 month of therapy, after 2 months)
- Change in baseline value of sustained maximal inspiratory pressure(baseline, after 1 month of therapy, after 2 months)
- Change in baseline value of maximal expiratory pressure(baseline, after 1 month of therapy, after 2 months)
Investigators
Marlon Wong
Physical Therapist
University of Miami