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Postural Training Device (UPRIGHT) for Back Pain

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ClinicalTrials.gov Identifier: NCT03449160
Recruitment Status : Withdrawn (COVID 19 which is preventing outpatient and elective procedures)
First Posted : February 28, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Byron Schneider, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment Phase
Back Pain Without Radiation Back Pain, Low Device: UPRIGHT Other: physical therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physical Therapy
Receive standard physical therapy
Other: physical therapy
routine physical therapy

Experimental: posture training device
Receive a posture training device in addition to standard physical therapy
Device: UPRIGHT
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




Primary Outcome Measures :
  1. Improvement/Change in Pain [ Time Frame: Primary outcome is at 6 weeks, secondary time point 12 weeks ]
    0-10 pain scale


Secondary Outcome Measures :
  1. Improvement/Change Disability [ Time Frame: 6 weeks, 12 weeks ]
    Modified Oswestry Disability Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449160


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
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Responsible Party: Byron Schneider, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03449160    
Other Study ID Numbers: BSCHNEIDERXX
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations