An interventional study of Physical Therapy in Low Back Pain, Motor Activity and Chronic Pain, sponsored by Texas Woman's University. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-06.
Sponsored by Texas Woman's University · Not applicable, Interventional, and Treatment
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
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).
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Texas Woman's University is the lead sponsor of 83 studies on the registry; 5 are open to participants now.
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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
Treatment arm: manipulation, exercise, and education
Procedure: Physical Therapy
Exercise, education, spinal manipulation
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
Time frame: 2 weeks
Visual Analog Scale
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
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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