Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
CompletedNot applicableNCT03589703
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 elicit…
Study details
- Official title
- Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
- Conditions
- 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)
- Sponsor
- The University of Texas Health Science Center, Houston
- Collaborators
- National Institute on Aging (NIA); Johns Hopkins University
- Start date
- 2019-03-01
- Primary completion
- 2022-12-06
- Sex
- All
- Age range
- from 60 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03589703