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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT03589703
Eligibility Criteria:
Inclusion Criteria:
* Age 60 years or older
* Able to read and write English
* cLBP that has persisted at least 3 months and has pain on at least half of the days for the previous 6 months
* Average intensity of pain ≥ 4 on a 11-point numerical pain scale in the previous week
* Have intact cognition (Mini-Mental State Examination (MMSE) \> 24)
* Willing to commit to up to 13-17 months as a study participant, depending on which group the participant is placed in
* Able to apply pressure to the seeds with tapes on their ears
Exclusion Criteria:
* Malignant or autoimmune diseases (e.g., rheumatoid arthritis), in which the pain from the disease cannot be separated from the low back pain by the participant
* Known acute compression fractures caused by osteoporosis, spinal stenosis, spondylolysis, or spondylolisthesis because these conditions may confound treatment effects or the interpretation of results
* Sciatica with leg pain greater than back pain
* Allergy to the tape
* Use of some types of hearing aids (size may obstruct the placement of seeds)
* Pain in other parts of the body that is more severe than the cLBP and which occurs daily or almost every day with at least moderate intensity or acute pain
* Neurological disorders that could interfere with pain reporting or confound performance on the other outcomes, cerebral tumor, Alzheimer's disease (or other cognitive illnesses), prior stroke, or multiple sclerosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03589703
Study Brief:
Protocol Section:
NCT03589703