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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: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable")

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

FieldValue
Enrollment Target 272 participants
Start Date 2019-03-01
Est. Completion 2023-01-01
Phase NA

What the finished NCT03589703 record still lists

NCT03589703 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03589703's enrollment target sits among peer trials

272 387th of 2000 higher than 1,614 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03589703, the US trial registry maintained by the National Library of Medicine. NCT03589703 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.