Baltimore, Maryland 21205

  • Chronic Low Back Pain

Purpose:

Almost one-third (30%) of persons 65 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 short-term analgesic effects or neuropeptide-induced anti-inflammatory cytokines, which may explain long-term effects. The Ecological Momentary Assessment (EMA) smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. Neuro-transmitters is measured by inflammatory biomarkers. Blood samples will be collected for serum collection and a multiplex bead-based immunofluorescence assay performed to check for serum levels. Mini-Mental State Examination will be used to screen for cognitive function, also HRQoL, satisfaction, treatment beliefs and expectations, sleep, relaxation effects, catastrophizing and fear/avoidance, and placebo effects will be measured.


Criteria:

Inclusion Criteria: - Age 65 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 months49 - The 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 4-weekly study visits and up to 12-months follow-up. - Able to apply pressure to the seeds with tapes on their ears. Exclusion Criteria: - Malignant or autoimmune diseases (e.g., rheumatoid arthritis). - 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.


NCT ID:

NCT03589703


Primary Contact:

Principal Investigator
Chao Hsing Yeh, PhD
Johns Hopkins University

Chao Hsing H Yeh, PhD
Phone: 6672087637
Email: cyeh13@jhu.edu


Backup Contact:

Email: cyeh13@jhu.edu
Chao Hsing H Yeh, MS
Phone: 6672087637


Location Contact:

Baltimore, Maryland 21205
United States



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Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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