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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT01658735
Eligibility Criteria:
Inclusion Criteria:
* Chronic Low Back Pain of at least 3 months duration
* ages 18-65
* Current VAS Pain Rating of 5 on 10 point scale
* No pain below the knee
* 75% of pain located in low back or buttock pain rather than lower extremity pain
* Proficient in English
* Able to complete and tolerate treatment for the study period.
Exclusion Criteria:
* Prior home use of H-Wave Device or TENS.
* Prior history of spinal fusion or failed spinal surgery syndrome.
* Laminectomy, laminotomy or discectomy within 12 months of enrollment.
* Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
* Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
* Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).
* Patients currently or who become pregnant will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01658735
Study Brief:
Protocol Section:
NCT01658735