Back to resultsShort-Term Effects of PT on Physical Activity
Primary Purpose
Low Back Pain, Motor Activity, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
1. Patient referred to outpatient PT with a LBP related diagnosis
2. LBP without radiating pain distally to the knee > 3 months in duration
3. Ability to read and write in English or Spanish
4. Age between 18 and 70 years
5. Able to ambulate independently without assistive devices
6. Access to a computer or cell phone with an email address and/or the ability to receive short text messages
Exclusion Criteria:
1. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine
2. 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
3. No surgical or biological fusion to the spine
4. No previous spinal surgery
5. No known diagnosis of osteoporosis or rheumatoid arthritis
6. No use of oral steroids within the past 6 months
7. No epidural injection over the previous 4-weeks to the lumbar spine region
8. No current litigation, workman's compensation or disability claim for a low back injury
9. No known pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical Therapy
Arm Description
Treatment arm: manipulation, exercise, and education
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02823756
Brief Title
Short-Term Effects of PT on Physical Activity
Official Title
The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
At session 1: Participants are screened for eligibility. Baseline outcome measures are conducted (self-report questionnaires and physical performance tests). Accelerometer which is an instrument to measure physical activity is issued.
At session 2 (To occur at least one-week later): Accelerometer data is retrieved and downloaded to a computer. Participant numerically rates low back pain level at rest and in most painful position. Participant receives a manual distraction procedure. Participant rates pain level again. Participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is reissued again.
At session 3 (At least one-week later): Accelerometer is collected and data is retrieved. Participant continues with the intervention (manipulation, exercise, education).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Motor Activity, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy
Arm Type
Experimental
Arm Description
Treatment arm: manipulation, exercise, and education
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Exercise, education, spinal manipulation
Primary Outcome Measure Information:
Title
Change in Physical Activity Levels
Description
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
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Visual Analog Scale
Description
A 10 cm horizontal line that the subject will use to descibe how intense their pain is before and after receiving a spinal manipulation by placing a vertical hash mark along the horizontal line to denote how intense his or her pain is.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patient referred to outpatient PT with a LBP related diagnosis
2. LBP without radiating pain distally to the knee > 3 months in duration
3. Ability to read and write in English or Spanish
4. Age between 18 and 70 years
5. Able to ambulate independently without assistive devices
6. Access to a computer or cell phone with an email address and/or the ability to receive short text messages
Exclusion Criteria:
1. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine
2. 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
3. No surgical or biological fusion to the spine
4. No previous spinal surgery
5. No known diagnosis of osteoporosis or rheumatoid arthritis
6. No use of oral steroids within the past 6 months
7. No epidural injection over the previous 4-weeks to the lumbar spine region
8. No current litigation, workman's compensation or disability claim for a low back injury
9. No known pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne A Brewer, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29208007
Citation
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.
Results Reference
derived
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Short-Term Effects of PT on Physical Activity
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