Chronic Pain (Back / Neck)NCT07179016
Evaluating the Auricular Point Acupressure-Self Management Program for Chronic Musculoskeletal Pain Among Rural Populations
A study testing Auricular Point Acupressure (APA) - Self Management (SM) in people with Chronic Pain (Back / Neck) and Chronic Pain Management, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial summary
The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain (Back / Neck), Chronic Pain Management, Chronic Knee Pain
- What is being tested?
- Auricular Point Acupressure (APA) - Self Management (SM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Sep 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receive any pain management for CMP (neck, back, shoulder, hands, hips, knees, feet)
- Have CMP ≥ 4 on a scale of 0-10 that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months
Who cannot join
- Severe ear skin disorder (Diagnosed with conditions e.g., eczema, lupus with skin involvement) which often require medical intervention and severe allergy to tape
- Inability or unwillingness to provide informed consent
- Use of some type of hearing aid where size may obstruct seed placement
- Not living in rural area
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Jennifer Kawi, PhD, MSN, FNP-BC, FAAN, 713-500-2293, jennifer.kawi@uth.tmc.edu
Sarah Pace, PhD, 803-220-5294, PACE3@email.sc.edu
- Not yet recruiting
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107
Jane Bolin, PhD, JD, BSN, 979-571-6536, Jane.Bolin@unthsc.edu
Tonychris Nnaka, PhD, MPH, RN, CPH, 817-735-5877, tonychris.nnaka@unthsc.edu
- Not yet recruiting
The University of Texas Health science Center at Houston
Houston, Texas, 77030
Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, 702-544-8426, Jennifer.Kawi@uth.tmc.edu
Jungkyung Min, PhD, MS, RN, 9794502091, Jungkyung.Min@uth.tmc.edu
About this study
Official title: A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.
The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). To maximize self-management of pain, the investigators developed a smartphone app which will allow the participants to learn to self-administer APA. The investigators will have 3 arms (APA-SM self-guided with remote training, APA-SM with in-person training, and Education Control) with 231 participants per arm (total=693 for 3 arms). The investigators will evaluate the clinical effectiveness of our 4-week APA-SM intervention compared to control in primary outcomes (pain intensity, pain interference, activity), secondary outcomes (HEAL Clinical Pain Core common data elements), and analgesic use up to 6 months follow-up.
Read the detailed description
The investigators integrated ecological momentary assessment into our app to measure real-world outcomes resulting in participants being able to self-monitor their progress, using this as an innovative behavior change strategy based on Bandura's self-efficacy, successfully initiating and maintaining behavior change. The primary endpoint will be immediate post-intervention with secondary endpoints at 1-month, 3-month, and 6-month follow-ups after the intervention. The investigators will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidence-based interventions while addressing pain care disparities for rural individuals with limited resources and/or endure long distances to specialty pain care. Study recruitment will be 3 1/2 to 4 years followed by data analysis.
- Being tested
- Auricular Point Acupressure (APA) - Self Management (SM), Education Control
- Keywords
- Chronic Pain, Rural population, Self-management, Chronic musculoskeletal pain, Auricular point acupressure
- Medical subject headings
- Chronic Pain, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Point Acupressure (APA) - Self Management (SM)Behavioural
APA is a noninvasive and needle-free pain management therapy based on the principles of acupuncture. The APA-SM intervention program is aimed to manage chronic musculoskeletal pain leveraging a mobile app containing APA videos and remote vs in-person guidance or coaching to practice APA based on APA study assignment.
Education ControlBehavioural
Education Control group receive an app but the content will be specific to pain and self-management (no APA content) and they practice pain self-management skills (no APA practice).
| Study group | Role | What they receive |
|---|---|---|
| Remote APA-SM Training | Experimental | APA-SM self-guided with remote training Receives: Behavioral: Auricular Point Acupressure (APA) - Self Management (SM) |
| In-person APA-SM Training | Experimental | APA-SM with in-person training Receives: Behavioral: Auricular Point Acupressure (APA) - Self Management (SM) |
| Pain Education | Active comparator | Education Control Receives: Behavioral: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey
This is a three-item questionnaire and each is scored from 0 (no pain) to 10(worst pain) for a maximum score of 30. Higher score indicating worse outcome
Measured: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months
Secondary outcomes (15)
Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)
This is a six-item questionnaire and each is scored from 0 (not at all) to 4 (all the time) for a maximum score of 24. Higher score indicating greater pain catastrophizing.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)
This is a 16-item questionnaire. Each item is scored from 0 (completely disagree) to 6 (completely agree) for a maximum score of 96. Higher score indicating greater fear-avoidance beliefs.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )
This is a two-item questionnaire and each is scored from 0 (not at all) to 3(nearly every day) for a maximum score of 6. Higher score indicating greater depression.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)
This is a two-item questionnaire and each is scored from 0 (not at all) to 3 (nearly every day) for a maximum score of 6. Higher score indicating more anxiety.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From
This consist of six-item questionnaire regarding pain severity and nine-item questionnaire regarding pain interference. Higher score indicates greater pain severity and interference.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b)
This is a six-item questionnaire and each is scored from 1 (unable to do) to 5 (without any difficulty) for a maximum score of 30. Higher score indicates better physical function.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ)
This is a 24-item questionnaire and each is scored 0 (no) or 1 (yes) for a maximum score of 24. Higher score indicates greater disability.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration)
This is a six-item questionnaire and each is scored from 1 (very good) to 5 (very poor) for a maximum score of 30. Higher scores indicate worse sleep disturbance. It also includes an additional single item (+Sleep Duration) assessing hours and minutes of sleep per night. Higher values indicates longer sleep duration.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2)
This is a two-item questionnaire and each is scored from 0 (not at all confident) to 6 (completely confident) for a maximum score of 12. Higher score indicating greater pain self-efficacy.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener
This is a five-item questionnaire and each is scored from 0 (daily or almost daily) to 4 (never) for a maximum score of 20. Higher score indicates lower substance use.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2)
This is a two-item questionnaire and each is scored from 1 (very poor/dissatisfied) to 5 (very good/satisfied) for a maximum score of 10. Higher score indicating better quality of life.
Measured: Baseline, post intervention(4 weeks after baseline)
Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL)
This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater positive outlook.
Measured: Baseline, post intervention(4 weeks after baseline)
Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL)
This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater treatment expectancy.
Measured: Baseline, post intervention(4 weeks after baseline)
Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL)
This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates more positive attitude toward CAM.
Measured: Baseline, post intervention (4 weeks after baseline)
Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary
Daily self-reported analgesic and opioid use (type, dose, frequency) recorded via EMA diary
Measured: Baseline, post intervention (4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start11 Sep 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain (Back / Neck)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 693 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Kawi, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179016
- Sponsor's protocol ID
- HSC-SN-25-0443
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have a Data Management and Sharing Plan and will comply with the policy set forth by NIH.
Publications
Kawi J, Bolin J, Wu H, Min J, Bora R, Pace S, Akpan IN, Lockman A, Nnaka T. Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial. BMJ Open. 2026 Jun 8;16(6):e117632. doi: 10.1136/bmjopen-2026-117632.
PubMed 42259555
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.
- ClinicalTrials.gov ID
- NCT07179016
- Acronym / sponsor ID
- HSC-SN-25-0443
- Keywords
- Chronic Pain, Rural population, Self-management, Chronic musculoskeletal pain, Auricular point acupressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). To maximize self-management of pain, the investigators developed a smartphone app which will allow the participants to learn to self-administer APA. The investigators will have 3 arms (APA-SM self-guided with remote training, APA-SM with in-person training, and Education Control) with 231 participants per arm (total=693 for 3 arms). The investigators will evaluate the clinical effectiveness of our 4-week APA-SM intervention compared to control in primary outcomes (pain intensity, pain interference, activity), secondary outcomes (HEAL Clinical Pain Core common data elements), and analgesic use up to 6 months follow-up.
Detailed description
The investigators integrated ecological momentary assessment into our app to measure real-world outcomes resulting in participants being able to self-monitor their progress, using this as an innovative behavior change strategy based on Bandura's self-efficacy, successfully initiating and maintaining behavior change. The primary endpoint will be immediate post-intervention with secondary endpoints at 1-month, 3-month, and 6-month follow-ups after the intervention. The investigators will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidence-based interventions while addressing pain care disparities for rural individuals with limited resources and/or endure long distances to specialty pain care. Study recruitment will be 3 1/2 to 4 years followed by data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote APA-SM Training | Experimental | Behavioral: Auricular Point Acupressure (APA) - Self Management (SM)APA-SM self-guided with remote training |
| In-person APA-SM Training | Experimental | Behavioral: Auricular Point Acupressure (APA) - Self Management (SM)APA-SM with in-person training |
| Pain Education | Active comparator | Behavioral: Education ControlEducation Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receive any pain management for CMP (neck, back, shoulder, hands, hips, knees, feet)
- Have CMP ≥ 4 on a scale of 0-10 that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months
Key exclusion criteria (4 listed)
- Severe ear skin disorder (Diagnosed with conditions e.g., eczema, lupus with skin involvement) which often require medical intervention and severe allergy to tape
- Inability or unwillingness to provide informed consent
- Use of some type of hearing aid where size may obstruct seed placement
- Not living in rural area
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 |
|---|---|---|
| Auricular Point Acupressure (APA) - Self Management (SM)APA is a noninvasive and needle-free pain management therapy based on the principles of acupuncture. The APA-SM intervention program is aimed to manage chronic musculoskeletal pain leveraging a mobile app containing APA videos and remote vs in-person guidance or coaching to practice APA based on APA study assignment. | Behavioural | In-person APA-SM Training, Remote APA-SM Training |
| Education ControlEducation Control group receive an app but the content will be specific to pain and self-management (no APA content) and they practice pain self-management skills (no APA practice). | Behavioural | Pain Education |
Primary outcome
Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey
Time frame: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months
This is a three-item questionnaire and each is scored from 0 (no pain) to 10(worst pain) for a maximum score of 30. Higher score indicating worse outcome
15 secondary outcomes
Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2)
Time frame: Baseline, post intervention(4 weeks after baseline)
Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL)
Time frame: Baseline, post intervention(4 weeks after baseline)
Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL)
Time frame: Baseline, post intervention(4 weeks after baseline)
Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL)
Time frame: Baseline, post intervention (4 weeks after baseline)
Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary
Time frame: Baseline, post intervention (4 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42259555Kawi J, Bolin J, Wu H, Min J, Bora R, Pace S, Akpan IN, Lockman A, Nnaka T. Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial. BMJ Open. 2026 Jun 8;16(6):e117632. doi: 10.1136/bmjopen-2026-117632.
- Individual participant dataSharing planned: No. We have a Data Management and Sharing Plan and will comply with the policy set forth by NIH.
Related trials for Chronic Pain (Back / Neck)
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain
Spine, Low Back Pain
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Lumbosacral Radiculopathy, Sciatica
Recruiting
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Chronic Back Pain, Chronic Pain (Back / Neck)
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.
Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Point Acupressure (APA) - Self Management (SM) in people with Chronic Pain (Back / Neck) and Chronic Pain Management, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN (713-500-2293, Jennifer.Kawi@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey (time frame: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months). 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 NCT07179016, which also lists 1 linked publication.
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 1 Oct 2025.