Back to resultsPostural Training Device (UPRIGHT) for Back Pain
Primary Purpose
Back Pain Without Radiation, Back Pain, Low
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UPRIGHT
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain Without Radiation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
*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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical Therapy
posture training device
Arm Description
Receive standard physical therapy
Receive a posture training device in addition to standard physical therapy
Outcomes
Primary Outcome Measures
Improvement/Change in Pain
0-10 pain scale
Secondary Outcome Measures
Improvement/Change Disability
Modified Oswestry Disability Index
Full Information
NCT ID
NCT03449160
First Posted
January 4, 2018
Last Updated
October 13, 2020
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03449160
Brief Title
Postural Training Device (UPRIGHT) for Back Pain
Official Title
Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID 19 which is preventing outpatient and elective procedures
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.
At 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Without Radiation, Back Pain, Low
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Receive standard physical therapy
Arm Title
posture training device
Arm Type
Experimental
Arm Description
Receive a posture training device in addition to standard physical therapy
Intervention Type
Device
Intervention Name(s)
UPRIGHT
Intervention Description
A small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained. The device is removable, and used for only portions of the day
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
routine physical therapy
Primary Outcome Measure Information:
Title
Improvement/Change in Pain
Description
0-10 pain scale
Time Frame
Primary outcome is at 6 weeks, secondary time point 12 weeks
Secondary Outcome Measure Information:
Title
Improvement/Change Disability
Description
Modified Oswestry Disability Index
Time Frame
6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
*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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Postural Training Device (UPRIGHT) for Back Pain
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