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WithdrawnNCT03449160Updated Oct 19, 2020

Postural Training Device (UPRIGHT) for Back Pain

An interventional study of UPRIGHT and physical therapy in Back Pain Without Radiation and Back Pain, Low, sponsored by Vanderbilt University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
COVID 19 which is preventing outpatient and elective procedures
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Back Pain Without Radiation
  • Back Pain, Low
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Physical Therapy

    Receive standard physical therapy

    Other: physical therapy

  • Experimental
    posture training device

    Receive a posture training device in addition to standard physical therapy

    Device: UPRIGHT

Interventions

  • DeviceUPRIGHT

    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

  • Otherphysical therapy

    routine physical therapy

05

What researchers measure

Primary outcomes

  1. Improvement/Change in Pain

    0-10 pain scale

    Time frame: Primary outcome is at 6 weeks, secondary time point 12 weeks

Secondary outcomes

  1. Improvement/Change Disability

    Modified Oswestry Disability Index

    Time frame: 6 weeks, 12 weeks

06

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449160
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Byron Schneider (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Feb 28, 2018
Start date
May 1, 2020 (estimated)
Primary completion
Feb 1, 2021 (estimated)
Completion
Feb 1, 2022 (estimated)
Last update
Oct 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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