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

Overview

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 short-term analgesic effects or neuropeptide-induced anti-inflammatory cytokines, which may explain long-term effects. The Ecological Momentary Assessment (EMA) smart phone 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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 6, 2022

Interventions

  • Other: Target ear points related to chronic low back pain (T-APA)
    • Light touch using vaccaria seeds on specific points of the ear.
  • Other: Non-Target ear Points not related to chronic low back pain (NT-APA)
    • Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: T-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.
  • Active Comparator: NT-APA
    • 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 non-target ear points of 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: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Pain intensity as assessed by the Numeric Rating Scale (NRS)
    • Time Frame: Baseline
    • 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”)
  • Pain intensity as assessed by the Numeric Rating Scale (NRS)
    • Time Frame: 1 month post completion of the treatment
    • 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”)
  • Pain interference as assessed by the Brief Pain Inventory-short form pain interference subscale
    • Time Frame: Baseline
    • Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0=”does not interfere” and 10=”completely interferes”).
  • Pain interference as assessed by the Brief Pain Inventory-short form pain interference subscale
    • Time Frame: 1 month post completion of the treatment
    • Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0=”does not interfere” and 10=”completely interferes”).
  • Physical Function as assessed by the Roland Morris Disability Questionnaire (RMDQ)
    • Time Frame: Baseline
    • The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability).
  • Physical Function as assessed by the Roland Morris Disability Questionnaire (RMDQ)
    • Time Frame: 1 month post completion of the treatment
    • The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability).

Secondary Measures

  • Number of participants who use opioids
    • Time Frame: Baseline
  • Number of participants who use opioids
    • Time Frame: 1 month post completion of the treatment
  • Treatment Satisfaction as assessed by Satisfaction Survey
    • Time Frame: immediately post intervention
    • Satisfaction is assessed using a 5-point numeric rating scale: Completely satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied
  • Treatment Satisfaction as assessed by Satisfaction Survey
    • Time Frame: 1 month post completion of the treatment
    • Satisfaction is assessed using a 5-point numeric rating scale: Completely satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Anxiety
    • Time Frame: Baseline
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Anxiety
    • Time Frame: 1 month post completion of the treatment
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Depression
    • Time Frame: Baseline
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Depression
    • Time Frame: 1 month post completion of the treatment
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Sleep Disturbance
    • Time Frame: Baseline
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) – Sleep Disturbance
    • Time Frame: 1 month post completion of the treatment
    • PROMIS-29 is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains: anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and satisfaction with participation in social roles. Each subscale includes 4 items of a 5-point Likert Scale (1 to 5). Scores will be summed to determine a domain’s health QOL, ranging from 4 to 20, and this score is converted to a T-score. T-score is reported here, and it ranges from 0 to 100, the higher the score, the better the quality of the domain.
  • Fear-Avoidance as assessed by the Fear-avoidance beliefs questionnaire (FABQ)
    • Time Frame: Baseline
    • 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.
  • Fear-Avoidance as assessed by the Fear-avoidance beliefs questionnaire (FABQ)
    • Time Frame: 1 month post completion of the treatment
    • 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.
  • Pain Catastrophizing as assessed by the Pain Catastrophizing Scale (PCS)
    • Time Frame: Baseline
    • 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.
  • Pain Catastrophizing as assessed by the Pain Catastrophizing Scale (PCS)
    • Time Frame: 1 month post completion of the treatment
    • 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.
  • Memory as assessed by the Stroop Test
    • Time Frame: Baseline
    • T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
  • Memory as assessed by the Stroop Test
    • Time Frame: 1 month post completion of the treatment
    • T-score will be reported, with a range of 0-100, with a higher score indicating better memory.
  • Relaxation as assessed by Relaxation Response
    • Time Frame: Baseline
  • Relaxation as assessed by Relaxation Response
    • Time Frame: 1 month post completion of the treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Constance Johnson, Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Constance Johnson, PhD, MS, RN, Principal Investigator, The University of Texas Health Science Center, Houston
    • Nada Lukkahatai, PhD, MSN, RN, Principal Investigator, Johns Hopkins University

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