Postural Training Device (UPRIGHT) for Back Pain

Not Applicable

Withdrawn

• Conditions: Back Pain, Low; Back Pain Without Radiation
• Interventions: Other: physical therapy; Device: UPRIGHT

• Registration Number: NCT03449160
• Lead Sponsor: 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Study Start: 2020-05-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Therapy	physical therapy	Receive standard physical therapy
posture training device	UPRIGHT	Receive a posture training device in addition to standard physical therapy

Primary Outcome Measures

Name	Time	Method
Improvement/Change in Pain	Primary outcome is at 6 weeks, secondary time point 12 weeks	0-10 pain scale

Secondary Outcome Measures

Name	Time	Method
Improvement/Change Disability	6 weeks, 12 weeks	Modified Oswestry Disability Index

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States