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Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure

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ClinicalTrials.gov Identifier: NCT03589703
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: APA Other: Comparison Group (CG-1) Other: Enhanced Educational Control Group (CG-2) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: APA
Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.
Other: APA
Light touch using vaccaria seeds on specific points of the ear.

Sham Comparator: Comparison Group (CG-1)

The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil.

These points are chosen for the sham APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.

Other: Comparison Group (CG-1)
Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

Enhanced Educational Control Group (CG-2)
Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Other: Enhanced Educational Control Group (CG-2)
No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 1 month post completion of the treatment ]
    The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

  2. Pain Interference [ Time Frame: 1 month post completion of the treatment ]
    The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, was used to assess the impact of back pain on their daily functioning. The score ranged from 0 (no disability) to 24 (maximum disability).

  3. Physical Function [ Time Frame: 1 month post completion of the treatment ]
    The Oswestry Disability Index (ODI) was used to measure a participants impairment and quality of life on 10 items with 0-5 point scales [37]. The score ranges from 0-100%; a lower score indicates less disability.


Secondary Outcome Measures :
  1. Health Related Quality of Life (HRQoL) [ Time Frame: Day 28 ]
    The WHO Quality of Life-BREF (WHOQOL-BREF), used to measure quality of life. The WHOQOL-BREF, is self-administered, and measures the following broad domains: physical health, psychological health, social relationships, and environment. Each individual item of the WHOQoL is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale.

  2. Treatment Satisfaction [ Time Frame: Day 28 ]
    The participants will be assessed using a 12-item scale, each item with score between 0-5 with 5 being most satisfied with treatment progress. Highest score of 60 (maximum satisfaction) and lowest score of 0 (least satisfaction)

  3. Fear-Avoidance [ Time Frame: Day 28 ]
    It is measured by Fear-avoidance beliefs questionnaire (FABQ) that focuses on participants beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. A higher score indicates more strongly held fear-avoidance beliefs.

  4. Placebo effect [ Time Frame: Baseline ]
    Treatment and nonspecific psychological placebo effects will be measured via HEAL treatment expectation and HEAL provider connection questionnaires. The participants will be asked few questions about their; confidence in treatment, treatment expectations, their value to the treatment, how good they feel about the treatment.

  5. Pain and Catastrophizing Scale (PCS) [ Time Frame: Day 28 ]
    The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of 13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain.This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," and high scores indicate stronger catastrophizing.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589703


Contacts
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Contact: Chao Hsing Yeh, PhD 4126239168 cyeh13@jhu.edu
Contact: Asha Krishna, MS 2407140803 akrish19@jhu.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Chao Hsing Yeh, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Chao Hsing Yeh, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03589703     History of Changes
Other Study ID Numbers: IRB00175409
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Chronic Low Back Pain
cLBP
pain
acupressure

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms