Clinical trial NCT03449160: Postural Training Device (UPRIGHT) for Back Pain
Official title: Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Back Pain Without Radiation
Back Pain, Low
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Improvement/Change in Pain
timeFrame: Primary outcome is at 6 weeks, secondary time point 12 weeks
Secondary outcomes:
measure: Improvement/Change Disability
timeFrame: 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: