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 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 Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Target ear points related to chronic low back pain (T-APA); Light touch using vaccaria seeds on specific points of the ear.
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: 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)	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")	Baseline
Pain Intensity as Assessed by the Numeric Rating Scale (NRS)	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")	1 month post completion of the treatment (2 months after baseline)
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale	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").	Baseline
Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale	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").	1 month post completion of the treatment (2 months after baseline)
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)	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).	Baseline
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)	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).	1 month post completion of the treatment (2 months after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Use Opioids		Baseline
Number of Participants Who Use Opioids		1 month post completion of the treatment (2 months after baseline)
APA Treatment Satisfaction as Assessed by Satisfaction Survey	Satisfaction is assessed using a 5-point numeric rating scale: - Completely satisfied; - Somewhat satisfied; - Neither satisfied nor dissatisfied; - Somewhat dissatisfied; - Very dissatisfied	immediately post intervention (1 month after baseline)
APA Treatment Satisfaction as Assessed by Satisfaction Survey	Satisfaction is assessed using a 5-point numeric rating scale: - Completely satisfied; - Somewhat satisfied; - Neither satisfied nor dissatisfied; - Somewhat dissatisfied; - Very dissatisfied	1 month post completion of the treatment (2 months after baseline)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.	Baseline
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.	1 month post completion of the treatment (2 months after baseline)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.	Baseline
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.	1 month post completion of the treatment (2 months after baseline)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.	Baseline
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance	The Patient-Reported Outcomes Measurement Information System (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-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.	1 month post completion of the treatment (2 months after baseline)
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)	The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's 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 and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.	Baseline
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)	The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's 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 and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.	1 month post completion of the treatment (2 months after baseline)
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)	The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 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," with higher scores indicate stronger catastrophizing.	Baseline
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)	The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 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," with higher scores indicate stronger catastrophizing.	1 month post completion of the treatment (2 months after baseline)
Memory as Assessed by the Stroop Test	T-score will be reported, with a range of 0-100, with a higher score indicating better memory.	Baseline
Memory as Assessed by the Stroop Test	T-score will be reported, with a range of 0-100, with a higher score indicating better memory.	1 month post completion of the treatment (2 months after baseline)
Relaxation as Assessed by Relaxation Response		Baseline
Relaxation as Assessed by Relaxation Response		1 month post completion of the treatment (2 months after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Johns Hopkins University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Constance Johnson, PhD, MS, RN, The University of Texas Health Science Center, Houston; Principal Investigator: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University

Publications and helpful links

General Publications

• Yeh CH, Li C, Glick R, Schlenk EA, Albers K, Suen LK, Lukkahatai N, Salen N, Pandiri S, Ma W, Perrin N, Morone NE, Christo PJ. A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol. Trials. 2020 Jan 20;21(1):99. doi: 10.1186/s13063-019-4016-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; Chronic Low Back Pain; acupressure; cLBP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HSC-SN-21-1059; 1R01AG056587-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No