Chronic Musculoskeletal PainNCT05020470
Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain
A study testing Virtual Auricular Point Acupressure (APA) and In-Person Training in people with Chronic Musculoskeletal Pain, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Virtual Auricular Point Acupressure (APA) and In-Person Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2021to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older.
- Receiving outpatient pain treatment for CMP condition (e.g., pain in the back, hip, knee, upper extremity, lower extremity, neck, pelvic, headache/migraine).
- Chronic pain ≥ 4 on a scale of 0-10 point numerical pain, persisting for at least 3 months or has resulted in pain on at least half the days in the past 6 months.
Who cannot join
- Disease that might confound therapeutic effects or explanation of outcomes, i.e., infection, malignant tumors, or autoimmune diseases.
- Severe ear skin issues.
- Use of some types of hearing aids (size may obstruct the placement of seeds)
- Concurrent major psychiatric disorder (i.e., participant self-report).
- Pregnant women will be excluded from the study based on the self-reported data.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
About this study
The proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes.
This study will randomly assign participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). EMA will be used to assess momentary pain outcomes and APA adherence.
Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments.
Read the detailed description
Chronic musculoskeletal pain (CMP) is the most common self-reported and clinically diagnosed pain condition in the US and costs up to $635 billion annually. Analgesics/opioids are the most common treatments utilized by patients with CMP, however, unnecessary opioid use has resulted in the current opioid epidemic. The Institute of Medicine recommended guidelines for non-pharmacologic, self-management strategies to manage pain. However, these guidelines have not been broadly implemented due to time constraints among healthcare providers, accessibility, patient's beliefs/motivations, and high cost/insurance coverage, especially among socioeconomically disadvantaged and vulnerable patients.
Auricular point acupressure (APA), a non-invasive procedure, provides acupuncture-like stimulations on ear points using small pellets instead of needles to self-manage pain. The investigator's interdisciplinary team has accumulated extensive evidence (11 clinical trials) supporting the efficacy of interventionist-administered APA to manage pain. The randomized clinical trial (RCT) comparing APA to sham APA demonstrated: (1) Significant rapid and sustained effect: APA resulted to ≥38% rapid pain relief among participants at three minutes post-APA; >44% pain relief and >28% improved physical function at follow-up after 4-weeks APA; (2) Reduced use of medications: After 4-weeks of APA, ≥60% of participants reported less use of pain medications; and (3) Significant impact on physiological measures: APA controls pain through blocking pro-inflammatory cytokines (IL-1β, IL-2) and modulating nerve sensitivity. No adverse effects from APA were reported.
The investigator's long-term goal is to eliminate pain care disparities and reduce society's reliance on opioids to manage pain. Leveraging technology, the proposed study will help advance mAPA, a novel, easy-to-initiate, rapid, safe, and non-pharmacologic tool incorporated in a self-management plan to manage pain in real-world settings. The proposed intervention promises to provide important and timely information to advance a non-opioid and self-managed pain treatment.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Virtual Auricular Point Acupressure (APA), In-Person Training, Usual Care
- Keywords
- Chronic Pain, Musculoskeletal, Auricular Point Acupressure
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Auricular Point Acupressure (APA)Device
Participants will learn how to self-administer APA by themselves.
In-Person TrainingOther
Participants will receive in-person training to self-administer APA.
Usual CareOther
Participants will continue to do whatever they are instructed by theirs physicians.
| Study group | Role | What they receive |
|---|---|---|
| Self-guided mAPA (S-mAPA) | Experimental | S-mAPA group will be provided with instructions so that participants can learn to self-administer APA weekly for four weeks and then followed by weekly telecommunication for Q \& As. Receives: Device: Virtual Auricular Point Acupressure (APA) |
| In-Person Training + mAPA (IP-mAPA) | Experimental | Participants will receive one in-person training after baseline data is collected and then will self-administer APA on the same schedule with weekly telecommunication as those in the mAPA group. Receives: Device: Virtual Auricular Point Acupressure (APA); Other: In-Person Training |
| Usual Care Control (UC) | Active comparator | Participants will receive usual care only for their pain; after enrolled, patients will receive weekly telecommunication to control for attention and time. The content of the phone/video call will focus on the pain problem they have and the investigators will provide additional information published by the National Center for Complementary and Integrative Health "Chronic Pain: In-Depth" (https://www.nccih.nih.gov/health/chronic-pain-in-depth) which the investigators used in the R01 study for participants enrolled in the control group Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.
Measured: Up to 4 months
Pain Interference
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).
Measured: Up to 4 months
Physical Function
The Oswestry Disability Index (ODI) was used to measure a participants impairment and quality of life on 10 items with 0-5 point scales. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5; a lower score indicates less disability.
Measured: Up to 4 months
Secondary outcomes (6)
Health Related Quality of Life (HRQoL)
The WHO Quality of Life-BREF (WHOQOL-BREF), used to measure quality of life. The WHOQOL-BREF, is self-administered, and measures the following broad domains: physical health, psychological health, social relationships, and environment. Each individual item of the WHOQoL is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval. The first two questions of the WHOQOL-BREF do not correspond to a domain, but are meant to provide a global assessment of quality of life. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: Up to 4 months
Treatment Satisfaction
The participants will be assessed using a 12-item Treatment Satisfaction Questionnaire, with 4 items with scored for treatment difficulty 1 (extremely difficult) - 5 (not difficult), 7 single-choice questions assessing satisfaction and effectiveness of treatment and 3 open-ended questions assessing satisfaction and effectiveness of treatment. Maximum score of 36; A higher score indicates more satisfaction from the treatment.
Measured: Up to 4 months
Fear-Avoidance
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. Maximum score of 96; A higher score indicates more strongly held fear-avoidance beliefs. The first 5 questions pertain to physical activity while the remaining 11 pertain to work. The Physical Activity subscale range 0-24 is the sum of items 2-5; the Work subscale, range 0-42 is the sum of items 6, 7, 9-12 and 15.
Measured: Up to 4 months
Placebo effect
Placebo effects will be measured via Healing Encounters and Attitudes Lists (HEAL) Treatment Expectation questionnaire. HEAL is an item bank comprised of 6 domains. The Treatment Expectancy questionnaire consists of 6 items on a 5 point scale - not at all to very much. Score range of 6-30 with higher score indicating better outcome.
Measured: Up to 4 months
Pain and Catastrophizing Scale (PCS)
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.
Measured: Up to 4 months
Positive Outlook
Pre and post treatment positive outlook effects will be measured via Healing Encounters and Attitudes Lists (HEAL) Positive Outlook scale. The participants will be assessed using a 6-item questionnaire, scored for outlook on life 1 (not at all) - 5 (very much). Score range of 6- 30; A higher score indicates more positive outlook and satisfaction with ones life.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start22 Sep 2021
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Factorial
- Model description
- This prospective, multisite study will randomly assign at least 30 participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments. Participants assigned to IP-mAPA but are unable to come in for the in person training can choose to be in the S-mAPA group; this data will be collected. EMA will be used to assess momentary pain outcomes and APA adherence. This pilot study will collect feasibility and pain-related outcomes at more than 1 study site. The consent process will occur virtually (via secure email). Due to the nature of this pilot study, the anticipated enrollment will be a total of at least N = 30.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Hsing Yeh, PhD, Principal investigator, Johns Hopkins School of NursingJennifer Kawi, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020470
- Sponsor's protocol ID
- IRB00290512
- Status last verified
- Jun 2023
- First submitted
- 19 Aug 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawi J, Yeh CH, Lukkahatai N, Hardwicke RL, Murphy T, Christo PJ. Exploring the Feasibility of Virtually Delivered Auricular Point Acupressure in Self-Managing Chronic Pain: Qualitative Study. Evid Based Complement Alternat Med. 2022 Aug 29;2022:8079691. doi: 10.1155/2022/8079691. eCollection 2022.
PubMed 36072397Yeh CH, Kawi J, Ni A, Christo P. Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study. Pain Manag Nurs. 2022 Jun;23(3):301-310. doi: 10.1016/j.pmn.2021.11.007. Epub 2021 Dec 25.
PubMed 34961729Kawi J, Yeh CH, Li M, Caswell Bs K, Mazraani Md M, Lukkahatai PhD Rn N, Mensah Rn S, Taylor J, Budhathoki C, Christo P. Auricular Point Acupressure Smartphone Application to Manage Chronic Musculoskeletal Pain: A Longitudinal, One-Group, Open Pilot Trial. Glob Adv Health Med. 2021 Jan 22;10:2164956120987531. doi: 10.1177/2164956120987531. eCollection 2021.
PubMed 33623727Yeh CH, Kawi J, Grant L, Huang X, Wu H, Hardwicke RL, Christo PJ. Self-Guided Smartphone Application to Manage Chronic Musculoskeletal Pain: A Randomized, Controlled Pilot Trial. Int J Environ Res Public Health. 2022 Nov 11;19(22):14875. doi: 10.3390/ijerph192214875.
PubMed 36429591Kawi J, Yeh CH, Grant L, Huang X, Wu H, Hua C, Christo P. Retention, adherence, and acceptability testing of a digital health intervention in a 3-group randomized controlled trial for chronic musculoskeletal pain. Complement Ther Med. 2024 May;81:103030. doi: 10.1016/j.ctim.2024.103030. Epub 2024 Mar 2.
PubMed 38437926
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing A Theory-Driven Self-Management Intervention for Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05020470
- Acronym / sponsor ID
- IRB00290512
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Chronic Pain, Musculoskeletal, Auricular Point Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 25 Aug 2021 (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 proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes.
This study will randomly assign participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). EMA will be used to assess momentary pain outcomes and APA adherence.
Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments.
Detailed description
Chronic musculoskeletal pain (CMP) is the most common self-reported and clinically diagnosed pain condition in the US and costs up to $635 billion annually. Analgesics/opioids are the most common treatments utilized by patients with CMP, however, unnecessary opioid use has resulted in the current opioid epidemic. The Institute of Medicine recommended guidelines for non-pharmacologic, self-management strategies to manage pain. However, these guidelines have not been broadly implemented due to time constraints among healthcare providers, accessibility, patient's beliefs/motivations, and high cost/insurance coverage, especially among socioeconomically disadvantaged and vulnerable patients.
Auricular point acupressure (APA), a non-invasive procedure, provides acupuncture-like stimulations on ear points using small pellets instead of needles to self-manage pain. The investigator's interdisciplinary team has accumulated extensive evidence (11 clinical trials) supporting the efficacy of interventionist-administered APA to manage pain. The randomized clinical trial (RCT) comparing APA to sham APA demonstrated: (1) Significant rapid and sustained effect: APA resulted to ≥38% rapid pain relief among participants at three minutes post-APA; >44% pain relief and >28% improved physical function at follow-up after 4-weeks APA; (2) Reduced use of medications: After 4-weeks of APA, ≥60% of participants reported less use of pain medications; and (3) Significant impact on physiological measures: APA controls pain through blocking pro-inflammatory cytokines (IL-1β, IL-2) and modulating nerve sensitivity. No adverse effects from APA were reported.
The investigator's long-term goal is to eliminate pain care disparities and reduce society's reliance on opioids to manage pain. Leveraging technology, the proposed study will help advance mAPA, a novel, easy-to-initiate, rapid, safe, and non-pharmacologic tool incorporated in a self-management plan to manage pain in real-world settings. The proposed intervention promises to provide important and timely information to advance a non-opioid and self-managed pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This prospective, multisite study will randomly assign at least 30 participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments. Participants assigned to IP-mAPA but are unable to come in for the in person training can choose to be in the S-mAPA group; this data will be collected. EMA will be used to assess momentary pain outcomes and APA adherence. This pilot study will collect feasibility and pain-related outcomes at more than 1 study site. The consent process will occur virtually (via secure email). Due to the nature of this pilot study, the anticipated enrollment will be a total of at least N = 30.
| Arm | Type | Receives |
|---|---|---|
| Self-guided mAPA (S-mAPA) | Experimental | Device: Virtual Auricular Point Acupressure (APA)S-mAPA group will be provided with instructions so that participants can learn to self-administer APA weekly for four weeks and then followed by weekly telecommunication for Q \& As. |
| In-Person Training + mAPA (IP-mAPA) | Experimental | Device: Virtual Auricular Point Acupressure (APA), Other: In-Person TrainingParticipants will receive one in-person training after baseline data is collected and then will self-administer APA on the same schedule with weekly telecommunication as those in the mAPA group. |
| Usual Care Control (UC) | Active comparator | Other: Usual CareParticipants will receive usual care only for their pain; after enrolled, patients will receive weekly telecommunication to control for attention and time. The content of the phone/video call will focus on the pain problem they have and the investigators will provide additional information published by the National Center for Complementary and Integrative Health "Chronic Pain: In-Depth" (https://www.nccih.nih.gov/health/chronic-pain-in-depth) which the investigators used in the R01 study for participants enrolled in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age or older.
- Receiving outpatient pain treatment for CMP condition (e.g., pain in the back, hip, knee, upper extremity, lower extremity, neck, pelvic, headache/migraine).
- Chronic pain ≥ 4 on a scale of 0-10 point numerical pain, persisting for at least 3 months or has resulted in pain on at least half the days in the past 6 months.
Key exclusion criteria (5 listed)
- Disease that might confound therapeutic effects or explanation of outcomes, i.e., infection, malignant tumors, or autoimmune diseases.
- Severe ear skin issues.
- Use of some types of hearing aids (size may obstruct the placement of seeds)
- Concurrent major psychiatric disorder (i.e., participant self-report).
- Pregnant women will be excluded from the study based on the self-reported data.
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 |
|---|---|---|
| Virtual Auricular Point Acupressure (APA)Participants will learn how to self-administer APA by themselves. | Device | In-Person Training + mAPA (IP-mAPA), Self-guided mAPA (S-mAPA) |
| In-Person TrainingParticipants will receive in-person training to self-administer APA. | Other | In-Person Training + mAPA (IP-mAPA) |
| Usual CareParticipants will continue to do whatever they are instructed by theirs physicians. | Other | Usual Care Control (UC) |
Primary outcome
Pain intensity
Time frame: Up to 4 months
The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.
Pain Interference
Time frame: Up to 4 months
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).
Physical Function
Time frame: Up to 4 months
The Oswestry Disability Index (ODI) was used to measure a participants impairment and quality of life on 10 items with 0-5 point scales. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5; a lower score indicates less disability.
6 secondary outcomes
Health Related Quality of Life (HRQoL)
Time frame: Up to 4 months
Treatment Satisfaction
Time frame: Up to 4 months
Fear-Avoidance
Time frame: Up to 4 months
Placebo effect
Time frame: Up to 4 months
Pain and Catastrophizing Scale (PCS)
Time frame: Up to 4 months
Positive Outlook
Time frame: Baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 36072397Kawi J, Yeh CH, Lukkahatai N, Hardwicke RL, Murphy T, Christo PJ. Exploring the Feasibility of Virtually Delivered Auricular Point Acupressure in Self-Managing Chronic Pain: Qualitative Study. Evid Based Complement Alternat Med. 2022 Aug 29;2022:8079691. doi: 10.1155/2022/8079691. eCollection 2022.
- Background: PubMed 34961729Yeh CH, Kawi J, Ni A, Christo P. Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study. Pain Manag Nurs. 2022 Jun;23(3):301-310. doi: 10.1016/j.pmn.2021.11.007. Epub 2021 Dec 25.
- Background: PubMed 33623727Kawi J, Yeh CH, Li M, Caswell Bs K, Mazraani Md M, Lukkahatai PhD Rn N, Mensah Rn S, Taylor J, Budhathoki C, Christo P. Auricular Point Acupressure Smartphone Application to Manage Chronic Musculoskeletal Pain: A Longitudinal, One-Group, Open Pilot Trial. Glob Adv Health Med. 2021 Jan 22;10:2164956120987531. doi: 10.1177/2164956120987531. eCollection 2021.
- Results publication: PubMed 36429591Yeh CH, Kawi J, Grant L, Huang X, Wu H, Hardwicke RL, Christo PJ. Self-Guided Smartphone Application to Manage Chronic Musculoskeletal Pain: A Randomized, Controlled Pilot Trial. Int J Environ Res Public Health. 2022 Nov 11;19(22):14875. doi: 10.3390/ijerph192214875.
- Derived from this study: PubMed 38437926Kawi J, Yeh CH, Grant L, Huang X, Wu H, Hua C, Christo P. Retention, adherence, and acceptability testing of a digital health intervention in a 3-group randomized controlled trial for chronic musculoskeletal pain. Complement Ther Med. 2024 May;81:103030. doi: 10.1016/j.ctim.2024.103030. Epub 2024 Mar 2.
- 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.
Chao Hsing Yeh, PhD principal investigator
Johns Hopkins School of Nursing
Jennifer Kawi, PhD principal investigator
University of Nevada, Las Vegas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Auricular Point Acupressure (APA) and In-Person Training in people with Chronic Musculoskeletal Pain, run by Johns Hopkins University at 2 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 3 inclusion and 5 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 12 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Up to 4 months). The study lists 3 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 NCT05020470, 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 12 Jun 2023.