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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02261233
Eligibility Criteria:
Inclusion Criteria:
All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for LBP participants:
* Age 21-65 years
* Independently ambulatory
* Able to speak and read English
* Able to understand study procedures and to comply with them for the entire length of the study.
* Willing to be randomized to either immediate or delayed treatment group.
* Musculoskeletal pain - primarily in the low back region
* Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain
* Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire
Exclusion Criteria:
All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.
Below is a list of exclusion criteria:
* Inability or unwillingness of individual to give written informed consent.
* Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment
* Workers' compensation benefits in the past 3 months or ongoing medical legal issues
* Possibly pregnant
* Obesity (BMI\>32)
* Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)
History of:
* Spinal surgery
* Spinal fracture
* Spinal infection (e.g., osteomyelitis)
* Cancer
Unresolved symptoms from:
* Head trauma
* Inner ear infection with associated balance and coordination problems
* Orthostatic hypotension
* Uncontrolled hypertension
* Vestibular disorder (e.g. vertigo)
Current diagnosis of:
* Significant spinal deformity (e.g., scoliosis \> 20 degrees, torticollis)
* Ankylosing spondylitis
* Spondylolisthesis grades III or IV
* Cauda equine syndrome
* Rheumatoid arthritis
* Osteoporosis
* Angina or congestive heart failure symptoms
* Active bleeding or infection in the back
* Blindness
* Seizures
* Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)
Conditions recognized by a physician any time during the study:
* Significant or worsening signs of neurologic deficit
* Symptoms are not consistent with mechanical findings
* Other conditions impeding protocol implementation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02261233
Study Brief:
Protocol Section:
NCT02261233