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

• ClinicalTrials.gov Identifier: NCT03589703
• Recruitment Status: Completed
• First Posted: July 18, 2018
• Last Update Posted: January 9, 2023
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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) 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: 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)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Patients in the control group were re-randomized to one of the APA groups after they completed 1-month (M) follow-up.
• 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
• Actual Primary Completion Date: December 6, 2022
• Actual Study Completion Date: January 1, 2023

Arms and Interventions

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).
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.

Outcome Measures

Primary Outcome Measures :

1. Pain intensity as assessed by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, immediately post-intervention, 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")
2. Function as assessed by the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline, immediately post-intervention, 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).

Secondary Outcome Measures :

1. Pain interference as assessed by the Brief Pain Inventory-short form, subscale [ Time Frame: Baseline, immediately post-intervention, 1 month post completion of the treatment ]
   Pain interference was assessed by the Brief Pain Inventory subscale with 7 pain-related functional interference questions using a 0-10 scale (0="does not interfere" and 10="completely interferes").
2. Fear-Avoidance as assessed by the Fear-avoidance beliefs questionnaire (FABQ) [ Time Frame: Baseline, immediately post-intervention, 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.
3. Placebo effect [ Time Frame: Baseline ]
   Treatment and nonspecific psychological placebo effects will be measured via HEAL treatment expectation questionnaire. The participants will be asked few questions about their treatment expectations about the treatment.
4. Pain as assessed by the Pain and Catastrophizing Scale (PCS) [ Time Frame: Baseline, immediately post-intervention, 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.
5. Treatment Satisfaction as assessed by Satisfaction Survey. [ Time Frame: immediately post intervention ]
   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)
6. Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 1 month post completion of the treatment ]
   PROMIS-29 is used to measure quality of life, including anxiety, depression, fatigue, and sleep disturbance. Each item includes a response scale, which is stipulated as a five-point ordinal scale.

Eligibility Criteria

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

Criteria

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 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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Paul Christo; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03589703
• Other Study ID Numbers: IRB00175409
• First Posted: July 18, 2018
• Last Update Posted: January 9, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations