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NCT03589703 · ClinicalTrials.gov registry record · NA
Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 272
- Enrollment target
NCT03589703 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 272 participants.
The verdict
NCT03589703, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 272 participants
- Enrollment target
Study Summary
Almost one-third (30%) of persons 60 years and older suffer from cLBP and cause a significant negative impact on individuals and society in the U.S. The goal of managing cLBP is decreased pain and disability.To accomplish this, cLBP sufferers often use analgesics including opioids to decrease pain and facilitate activity, but the side effects caused by these medications are problematic. A better pain management strategy clearly needs to be developed. The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and an innovative solution for chronic low back pain (cLBP) in older adults. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage participants' pain. Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. Studies suggest that stimulation of ear points (1) excites the somatotopic reflex system in the brain and that pathological brain patterns are electrically reset to stop the unwanted activation of spinal pain pathways, explaining the possible immediate pain relief that patients feel after APA and (2) cause a broad spectrum of systemic effects, such as vasodilation, by releasing endorphin to elic
Interventions
- OTHER Target ear points related to chronic low back pain (T-APA)
- OTHER Non-Target ear Points not related to chronic low back pain (NT-APA)
- OTHER Enhanced Educational Control Group (CG-2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2023-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03589703
The ClinicalTrials.gov registry entry for NCT03589703 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Target ear points related to chronic low back pain (T-APA) is the first listed.
NCT03589703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03589703 about?
NCT03589703 is a clinical study titled "Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure". Almost one-third (30%) of persons 60 years and older suffer from cLBP and cause a significant negative impact on individuals and society in the U.S. The goal of managing cLBP is decreased pain and disability.To accomplish this, cLBP sufferers often use analgesics including opioids to decrease pain a...
What is the current status of trial NCT03589703?
This trial is currently completed. It is a NA study. The enrollment target is 272 participants. The study started on 2019-03-01. Estimated completion is 2023-01-01.
What interventions are being tested in trial NCT03589703?
The interventions under investigation include: Target ear points related to chronic low back pain (T-APA) (OTHER), Non-Target ear Points not related to chronic low back pain (NT-APA) (OTHER), Enhanced Educational Control Group (CG-2) (OTHER).
Who is sponsoring clinical trial NCT03589703?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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