Short-Term Effects of PT on Physical Activity
The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels
1 other identifier
interventional
27
0 countries
N/A
Brief Summary
The primary purpose is to examine the impact that physical therapy (PT) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (LBP) as measured both objectively with an accelerometer and subjectively with questionnaires. The secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk distance, lower extremity muscle endurance. The tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Mar 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedJuly 6, 2016
June 1, 2016
1.1 years
June 29, 2016
June 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Physical Activity Levels
Accelerometer issued to subject at the initial data collection session and then data collected and downloaded one week later. Subject receives the intervention session, then is reissued the accelerometer. Subject returns the accelerometer one week after this intervention session with data that reflects physical activity levels that are after the intervention session
2 weeks
Other Outcomes (1)
Visual Analog Scale
1 day
Study Arms (1)
Physical Therapy
EXPERIMENTALTreatment arm: manipulation, exercise, and education
Interventions
Eligibility Criteria
You may qualify if:
- \. Patient referred to outpatient PT with a LBP related diagnosis
- \. LBP without radiating pain distally to the knee \> 3 months in duration
- \. Ability to read and write in English or Spanish
- \. Age between 18 and 70 years
- \. Able to ambulate independently without assistive devices
- \. Access to a computer or cell phone with an email address and/or the ability to receive short text messages
You may not qualify if:
- \. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine
- \. No clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee
- \. No surgical or biological fusion to the spine
- \. No previous spinal surgery
- \. No known diagnosis of osteoporosis or rheumatoid arthritis
- \. No use of oral steroids within the past 6 months
- \. No epidural injection over the previous 4-weeks to the lumbar spine region
- \. No current litigation, workman's compensation or disability claim for a low back injury
- \. No known pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Brewer W, Swanson BT, Roddey TS, Adewale H, Ashmore C, Frerich J, Perrin C, Ortiz A. A pilot study to determine the effect of one physical therapy session on physical activity levels for individuals with chronic low back pain. BMC Res Notes. 2017 Dec 6;10(1):691. doi: 10.1186/s13104-017-3006-x.
PMID: 29208007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne A Brewer, PhD
Texas Woman's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 6, 2016
Study Start
March 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
July 6, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share