Postural Training Device (UPRIGHT) for Back Pain

Vanderbilt University Medical Center

Status

Withdrawn

Conditions

Back Pain, Low

Back Pain Without Radiation

Treatments

Other: physical therapy

Device: UPRIGHT

Study type

Interventional

Funder types

Other

Identifiers

NCT03449160

BSCHNEIDERXX

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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