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:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01670292
Eligibility Criteria:
Inclusion Criteria:
* NRS score, AVERAGE within the past 24 hours
* Must be ≥4 at the phone screen or baseline 1 visit
* Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
* Roland Morris Disability ≥6
* Age 21-65
* Signed informed consent document
* Chronic (12+ weeks) low back pain
Exclusion Criteria:
* Compliance concerns
* No manipulable lesion in L1-L5 or SI joints
* The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
* Ongoing treatment for low back pain by outside provider
* Comorbid conditions
* Serious concomitant illness
* Inflammatory or destructive spinal tissue change
* Ankylosing Spondylytis
* Fibromyalgia
* Rheumatoid Arthritis
* Confirmed or suspected disc herniation with neurological signs
* Neuromuscular disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis
* Spinal surgery \<6 months
* Suspicion of drug or alcohol dependence or abuse
* Uncontrolled hypertension
* Lower extremity peripheral arterial disease
* Undetermined, infections or visceral source of low back pain
* Other comorbid conditions prohibiting treatment and/or testing
* Safety concerns
* Bleeding disorders
* Contraindications to High Velocity Low Amplitude Spinal Manipulation
* Inability to tolerate or obtain positon for flexion-relaxation test without condition aggravation
* Inability to tolerate or perform/receive any study procedure without condition aggravation
* Quebec Task Force (QTF) criterion 4-11:
* QTF 4: Pain + radiation to upper/lower limb with neurologic signs
* QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram
* QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques
* QTF 7: Spinal Stenosis
* QTF 8: Postsurgical status, 1-6 months after intervention
* QTF 9: Postsurgical status, \>6 months after intervention
* QTF 10: Chronic pain syndrome
* QTF 11: Other diagnoses
* Pregnancy
* Pacemaker or defibrillator
* Inability to read or verbally comprehend English
* Joint replacement
* Use of spinal manipulation within past 4 weeks
* Sensitivity to adhesive
* Diagnostic procedures other than x-ray/UA necessary
* BDI-II ≥29
* Retention of legal advice and open or pending case related to low back pain
* BMI ≥40
* Unwilling to have low back and wrist shaved
* Moving from Quad Cities area within next 8 weeks
* Unwilling to postpone treatments for low back pain from another provider
* Seeking or receiving compensation for any disability
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01670292
Study Brief:
Protocol Section:
NCT01670292