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

NCT ID: NCT03589703

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Group Type: OTHER

Enhanced Educational Control Group (CG-2)

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Constance Johnson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constance Johnson, PhD, MS, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Nada Lukkahatai, PhD, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40152243 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31959226 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01AG056587-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SN-21-1059

Identifier Type: -

Identifier Source: org_study_id