Postural Training Device (UPRIGHT) for Back Pain | NCT03449160

Studies
Postural Training Device (UPRIGHT) for Back Pain

NCT03449160

Sponsor

Vanderbilt University Medical Center

Status

Withdrawn

Last Update Posted

Oct 19, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Back Pain Without Radiation
Back Pain, Low

Interventions

UPRIGHT
physical therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID 19 which is preventing outpatient and elective procedures

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Jan 4, 2018

First Submission Date that Met QC Criteria

Feb 27, 2018

First Posted Date

Feb 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2020

Last Update Posted Date

Oct 19, 2020Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001416	Back Pain
D017116	Low Back Pain

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation