Status:
WITHDRAWN
Postural Training Device (UPRIGHT) for Back Pain
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Back Pain Without Radiation
Back Pain, Low
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device
Detailed Description
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device. Physical th...
Eligibility Criteria
Inclusion
- Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions
- Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation
- 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation
- Pain duration of at least 2 months
- Patient owns and is familiar with the use of a personal smart phone
- Patient consents to treatment with postural based physical therapy. In order to maintain blinding, patients will not be provided with details of the treatment plan until after the randomization process has been performed. They will only be informed of the treatment protocol for the group to which they have been assigned.
Exclusion
- \*History of prior thoracic or lumbar fusion surgery
- Acute Spine fracture
- Current pregnancy
- BMI over 40
- Inability to sense UPRIGHT vibration
- Active Systemic inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus)
- Medical conditions causing significant functional disability (e.g. stroke, spinal cord injury, amputation)
- Severe Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)
- Severe clinical depression, or psychotic features
- Implanted electrical medical device (i.e. cardiac pacemaker/defibrillator, spinal cord stimulator, bladder stimulator)
- Allergic skin reaction to tapes or adhesives
- Worker's compensation claim or legal action related to the thoracic or lumbar pain
- Patients unable to read English and complete the assessment instruments
- Patients unable to attend assigned physical therapy sessions
- Incarcerated patients
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03449160
Start Date
May 1 2020
End Date
February 1 2022
Last Update
October 19 2020
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212