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

NCT03589703 | Completed Results

• 2 other identifiers: HSC-SN-21-10591R01AG056587-01A1
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 2

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) 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.

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain; cLBP; pain; acupressure

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• 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

  immediately post intervention (1 month after baseline)

• APA Treatment Satisfaction as Assessed by Satisfaction Survey

  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

  Baseline

Study Arms (3)

T-APA

ACTIVE COMPARATOR

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)

NT-APA

ACTIVE COMPARATOR

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)

Enhanced Educational Control Group (CG-2)

OTHER

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)

Interventions

Target ear points related to chronic low back pain (T-APA) OTHER

Light touch using vaccaria seeds on specific points of the ear.

T-APA

Non-Target ear Points not related to chronic low back pain (NT-APA) OTHER

Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

NT-APA

Enhanced Educational Control Group (CG-2) OTHER

No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.

Enhanced Educational Control Group (CG-2)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Zhang J, Castelli G, Shen A, Li J, Kawi J, Wu H, Christo P, Campbell CM, Thrul J, Johnson CM, Lukkahatai N. Effectiveness of acupressure at different ear acupoints on Insomnia: A secondary analysis of a randomized controlled trial. Sleep Med X. 2025 Oct 15;10:100158. doi: 10.1016/j.sleepx.2025.100158. eCollection 2025 Dec 15.

  PMID: 41170529 DERIVED

• Kawi J, Yeh CH, Lukkahatai N, Wu H, Morone NE, Glick R, Schlenk EA, Campbell C, Thrul J, Huang X, Wang H, Jia HM, Christo P, Johnson C. Auricular point acupressure for older adults with chronic low back pain: a randomized controlled trial. Pain Med. 2025 Sep 1;26(9):515-526. doi: 10.1093/pm/pnaf035.

  PMID: 40152243 DERIVED

• 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.

  PMID: 31959226 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nada Lukkahatai, PhD, MSN, RN, CNE, FAAN
• Organization: Johns Hopkins University

nada.lukkahatai@jhu.edu

410-614-5297

Study Officials

• Constance Johnson, PhD, MS, RN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Nada Lukkahatai, PhD, MSN, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 18, 2018
• Study Start: March 1, 2019
• Primary Completion: December 6, 2022
• Study Completion: January 1, 2023
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)