Postural Training Device (UPRIGHT) for Back Pain

NCT03449160 | Withdrawn

• 1 other identifier: BSCHNEIDERXX
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Back Pain Without Radiation; Back Pain, Low

Outcome Measures

Primary Outcomes (1)

• Improvement/Change in Pain

  0-10 pain scale

  Primary outcome is at 6 weeks, secondary time point 12 weeks

Secondary Outcomes (1)

• Improvement/Change Disability

  6 weeks, 12 weeks

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR

Receive standard physical therapy

Other: physical therapy

posture training device

EXPERIMENTAL

Receive a posture training device in addition to standard physical therapy

Device: UPRIGHT

Interventions

UPRIGHT DEVICE

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

posture training device

physical therapy OTHER

routine physical therapy

Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \*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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 28, 2018
• Study Start: May 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)