Chronic Low Back PainNCT03589703

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

A study testing Target ear points related to chronic low back pain (T-APA) and Non-Target ear Points not related to chronic low back pain (NT-APA) in people with Chronic Low Back Pain, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Target ear points related to chronic low back pain (T-APA) and Non-Target ear Points not related to chronic low back pain (NT-APA)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: 2 sitesUnited States
Study dates: 1 Mar 2019to 1 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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
Being tested: Target ear points related to chronic low back pain (T-APA), Non-Target ear Points not related to chronic low back pain (NT-APA), Enhanced Educational Control Group (CG-2)
Keywords: Chronic Low Back Pain, cLBP, pain, acupressure
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Target ear points related to chronic low back pain (T-APA)Other
Light touch using vaccaria seeds on specific points of the ear.
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).
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.

Study groups in NCT03589703
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Enhanced Educational Control Group (CG-2)

What is being measured

The primary outcome is the main question the study is designed to answer.

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")
Measured: 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")
Measured: 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").
Measured: 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").
Measured: 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).
Measured: 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).
Measured: 1 month post completion of the treatment (2 months after baseline)

Secondary outcomes (18)

Number of Participants Who Use Opioids
Measured: Baseline
Number of Participants Who Use Opioids
Measured: 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:
1. - Completely satisfied
2. - Somewhat satisfied
3. - Neither satisfied nor dissatisfied
4. - Somewhat dissatisfied
5. - Very dissatisfied
Measured: 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:
1. - Completely satisfied
2. - Somewhat satisfied
3. - Neither satisfied nor dissatisfied
4. - Somewhat dissatisfied
5. - Very dissatisfied
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month post completion of the treatment (2 months after baseline)
Relaxation as Assessed by Relaxation Response
Measured: Baseline
Relaxation as Assessed by Relaxation Response
Measured: 1 month post completion of the treatment (2 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20191 Jan 2023

First posted18 Jul 2018
Study start1 Mar 2019
Primary completion6 Dec 2022
Study completion1 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03589703
Sponsor's protocol ID: HSC-SN-21-1059
Other IDs: 1R01AG056587-01A1
Status last verified: Apr 2024
First submitted: 22 May 2018
Last updated: 24 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lukkahatai N, Benjasirisan C, Huang X, Wu H, Kawi J, Zhang J, Campbell CM, Johnson CM, Christo PJ, Thrul J. Smartphone-Based Ecological Momentary Assessment of Pain in Older Adults Undergoing Auricular Point Acupressure for Chronic Low Back Pain: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2026 Mar 4;10:e79612. doi: 10.2196/79612.
PubMed 41780915
Lukkahatai N, Wang H, Huang X, Chen W, Wu H, Kawi J, Yu Z, M Johnson C, Christo P. Effects of auricular point acupressure on inflammatory signaling in chronic low back pain: a secondary analysis of a randomized controlled trial. BMC Complement Med Ther. 2025 Dec 29;26(1):35. doi: 10.1186/s12906-025-05227-9.
PubMed 41462220
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.
PubMed 41170529
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.
PubMed 40152243
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.
PubMed 31959226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
ClinicalTrials.gov ID: NCT03589703
Acronym / sponsor ID: HSC-SN-21-1059
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain, cLBP, pain, acupressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Johns Hopkins University
Study start: 1 Mar 2019 (actual)
Primary completion: 6 Dec 2022 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 18 Jul 2018 (actual)
Results: Posted 24 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
T-APA	Active comparator	Other: Target ear points related to chronic low back pain (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.
NT-APA	Active comparator	Other: Non-Target ear Points not related to chronic low back pain (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.
Enhanced Educational Control Group (CG-2)	Other	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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Target ear points related to chronic low back pain (T-APA)Light touch using vaccaria seeds on specific points of the ear.	Other	T-APA
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	NT-APA
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.	Other	Enhanced Educational Control Group (CG-2)

Primary outcome

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 (2 months after 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 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 (2 months after 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").
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 (2 months after 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).

18 secondary outcomes

Number of Participants Who Use Opioids
Time frame: Baseline
Number of Participants Who Use Opioids
Time frame: 1 month post completion of the treatment (2 months after baseline)
APA Treatment Satisfaction as Assessed by Satisfaction Survey
Time frame: immediately post intervention (1 month after baseline)
APA Treatment Satisfaction as Assessed by Satisfaction Survey
Time frame: 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
Time frame: Baseline
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 (2 months after baseline)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
Time frame: Baseline
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 (2 months after baseline)
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
Time frame: Baseline
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 (2 months after baseline)
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline
Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
Time frame: 1 month post completion of the treatment (2 months after baseline)
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: 1 month post completion of the treatment (2 months after baseline)
Memory as Assessed by the Stroop Test
Time frame: Baseline
Memory as Assessed by the Stroop Test
Time frame: 1 month post completion of the treatment (2 months after baseline)
Relaxation as Assessed by Relaxation Response
Time frame: Baseline
Relaxation as Assessed by Relaxation Response
Time frame: 1 month post completion of the treatment (2 months after baseline)

Results and safety

Results posted to the registry on 24 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T-APA	92	81
NT-APA	91	68
Enhanced Educational Control Group (CG-2)	89	71

Primary outcome: Pain Intensity as Assessed by the Numeric Rating Scale (NRS)

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	T-APA n = 92	NT-APA n = 91	Enhanced Educational Control Group (CG-2) n = 89
Value	7.4 (1.7)	7.0 (1.8)	7.3 (1.7)

Primary outcome: Pain Intensity as Assessed by the Numeric Rating Scale (NRS)

Time frame: 1 month post completion of the treatment (2 months after baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	T-APA n = 81	NT-APA n = 72	Enhanced Educational Control Group (CG-2) n = 69
Value	5.6 (2.7)	5.3 (2.7)	6.6 (2.2)

Population analysed: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.

Primary outcome: Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	T-APA n = 92	NT-APA n = 91	Enhanced Educational Control Group (CG-2) n = 89
Value	3.2 (1.7)	3.3 (1.7)	3.1 (1.6)

Primary outcome: Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale

Time frame: 1 month post completion of the treatment (2 months after baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	T-APA n = 81	NT-APA n = 72	Enhanced Educational Control Group (CG-2) n = 69
Value	2.7 (1.9)	2.5 (1.6)	2.9 (1.7)

Population analysed: Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: from start of intervention to end of intervention (4 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T-APA	0 of 92 (0%)	69 of 92 (75%)	0 of 92
NT-APA	0 of 91 (0%)	48 of 91 (52.7%)	0 of 91
Enhanced Educational Control Group (CG-2)	0 of 89 (0%)	0 of 89 (0%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41780915Lukkahatai N, Benjasirisan C, Huang X, Wu H, Kawi J, Zhang J, Campbell CM, Johnson CM, Christo PJ, Thrul J. Smartphone-Based Ecological Momentary Assessment of Pain in Older Adults Undergoing Auricular Point Acupressure for Chronic Low Back Pain: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2026 Mar 4;10:e79612. doi: 10.2196/79612.
Derived from this study: PubMed 41462220Lukkahatai N, Wang H, Huang X, Chen W, Wu H, Kawi J, Yu Z, M Johnson C, Christo P. Effects of auricular point acupressure on inflammatory signaling in chronic low back pain: a secondary analysis of a randomized controlled trial. BMC Complement Med Ther. 2025 Dec 29;26(1):35. doi: 10.1186/s12906-025-05227-9.
Derived from this study: PubMed 41170529Zhang 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.
Derived from this study: PubMed 40152243Kawi 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.
Derived from this study: PubMed 31959226Yeh 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity as Assessed by the Numeric Rating Scale (NRS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589703, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.