Postural Training Device (UPRIGHT) for Back Pain

Back Pain, Low Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03449160
• Other study ID #: BSCHNEIDERXX
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: October 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Without Radiation
• Back Pain, Low
• Low Back Pain

Intervention

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

Other:
• physical therapy
routine physical therapy

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement/Change in Pain	0-10 pain scale	Primary outcome is at 6 weeks, secondary time point 12 weeks
Secondary	Improvement/Change Disability	Modified Oswestry Disability Index	6 weeks, 12 weeks