Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03449160
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03449160
Study Brief:
Protocol Section:
NCT03449160