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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01562756
Eligibility Criteria:
Inclusion Criteria:
* Age 21-65
* Signed informed consent document
* Chronic (12+ weeks) low back pain (LBP)
* Average pain within past 24 hours ≥ 2/10 at phone screen, baseline visit 1, and baseline visit 2
Exclusion Criteria:
* Compliance concerns such as refusal to shave body hair
* No manipulable lesion in L3, L4, 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)
* Comorbid Conditions:
* Serious Contaminant Illness
* Inflammatory or Destructive Spinal Tissue change
* Ankylosing Spondylitis
* Fibromyalgia
* Rheumatoid Arthritis
* Neuromuscular Disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis)
* Spinal Surgery \< 6 mo
* Suspicion of drug or alcohol abuse
* Uncontrolled hypertension
* Peripheral Arterial Disease
* Undetermined, infectious or visceral source of LBP
* Other comorbid conditions prohibiting treatment and/or testing
* Safety Concerns
* Bleeding Disorders
* Contraindications to HVLA-SM
* Quebec Task Force (QTF) criterion 4-11:
* QTF 4: Pain + radiation to upper/lower limb with 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
* Sensitivity to adhesive
* Additional diagnostic procedures other than x-ray necessary
* BDI-II \> 29
* Retention of legal advice and open or pending case related to LBP
* BMI \> 40
* Unwilling to have low back and wrist shaved
* Seeking or receiving compensation for any disability?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01562756
Study Brief:
Protocol Section:
NCT01562756