Postural Training Device (UPRIGHT) for Back Pain

Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Back Pain, Low; Back Pain Without Radiation
• Intervention / Treatment: Other: physical therapy; Device: UPRIGHT

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement/Change in Pain	0-10 pain scale	Primary outcome is at 6 weeks, secondary time point 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement/Change Disability	Modified Oswestry Disability Index	6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: BSCHNEIDERXX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No