Low Back PainNCT05423145
Self-Administered Acupressure for Veterans With Chronic Back Pain
A study testing self-administered acupressure in people with Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- self-administered acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 30 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans enrolled at VA Ann Arbor Healthcare System
- non-specific low back pain confirmed through electronic medical records (i.e., ICD-10 codes: M54.5, M54.40, 41, 42, M54.89)
- reported pain severity of 4/10 that has persisted for at least 3 months and present on most days
- medically stable (no hospitalizations in the past month lasting 3 or more days)
- no changes in pain medication regimen in past 4 weeks
- no planned surgery or injections for back pain during the next 10 weeks
Who cannot join
- pregnant
- had back surgery in the past 2 years
- received acupuncture or acupressure in past 3 months
- evidence of cognitive impairment that could interfere with the ability to provide consent and follow the study protocol (defined as a score of 3 using the Callahan et al. 6-item screener)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
About this study
Official title: Self-Administered Acupressure for Veterans With Chronic Back Pain: A Multisite Evaluation of Effectiveness and Implementation
Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain.
This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks.
Read the detailed description
This is a hybrid Type 1 effectiveness implementation study. The primary aim is to conduct a 2-group, randomized controlled trial to examine the effectiveness of stimulating acupressure compared to a waitlist control group for Veterans with chronic low back pain. Study participants will include Veterans Health Administration patients within the VA Ann Arbor Healthcare System who suffer from chronic low back pain and are interested in trying acupressure as a form of pain management. The second aim is to assess facilitators and barriers to implementing this type of acupressure program in VHA.
Specifically, this study will determine the effectiveness of a 6-week self-administered acupressure protocol on outcomes of pain interference, fatigue, sleep quality, and disability, at 6- and 10-weeks post baseline compared to a waitlist control group. The investigators hypothesize that outcomes will be improved from baseline for Veterans after 6 weeks of acupressure practice, and improvements will persist for the following 4 weeks. Intervention effects will be moderated by opioid use at baseline, age, sex, and baseline pain interference.
The study will recruit and enroll 300 Veterans with chronic low back pain, who will be randomized into one of two study arms: stimulating acupressure or a waitlist control group. These Veterans will be recruited in multiple ways, including through Whole Health classes offered at the study facilities, provider referral and proactive outreach, with potentially eligible participants identified using electronic health record data available through the VHA's Corporate Data Warehouse. All participants will attend an introductory acupressure class, conducted either virtually or in person, that provides a general overview of acupressure for chronic back pain, demonstrates how to find an acupressure point and how much pressure to apply.
After completing the consent process and a baseline survey, participants will be randomized to the acupressure intervention or waitlist control group. Participants will be allocated into groups in a 1:1 ratio by block randomization with mixed block sizes and stratified by sex to ensure balance of females and males across groups. Participants randomized to the intervention will then receive a tablet computer with an app that provides specific instructions on how to self-administer stimulating acupressure and identify acupressure points for treating back pain. Intervention participants will be asked to follow a 6-week protocol that involves performing acupressure once per day, for approximately 30 minutes, guided by the app. After 6 weeks, they will be asked to stop acupressure for 4 weeks so persisting effects can be determined. Participants in the waitlist control group will receive a tablet with the app at the end of 10 weeks. Survey based outcome assessments will be conducted at 6 weeks and 10 weeks.
The ultimate goal of this study is to identify effective and accessible non-pharmacological treatments for chronic pain, which are critically needed both inside and outside VHA.
- Conditions
- Low Back Pain
- Being tested
- self-administered acupressure
- Keywords
- acupressure, complementary therapies
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered acupressureBehavioural
The acupressure intervention is self-administered. The intervention group receives an app that instructs them on how to perform a stimulating acupressure protocol, consisting of six acupoints with four of the acupoints performed on both the left and the right sides of the body for a total of ten points. Each of the ten acupoints is to be stimulated for 3 minutes per point for a total treatment time of 30 minutes daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| acupressure intervention | Experimental | Receives access to the acupressure intervention Receives: Behavioral: self-administered acupressure |
| wait list control | No intervention | No access to the acupressure intervention during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PROMIS 6b pain interference scale
The Pain Interference Scale provides an assessment of the impact of pain on several aspects of functioning, including social and emotional processes as well as physical function (e.g., how much did pain interfere with your day to day activities) based on 6 items rated on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing greater interference (worse function). PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 60 represents a score that is 1 standard deviation above the US national average, and a 40 represents a score that is 1 standard deviation below the national average.
Measured: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Secondary outcomes (3)
change in PROMIS 8a fatigue scale
The fatigue scale consists of 8 items that assess the degree and impact of fatigue with each item rated on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse fatigue. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 60 represents a score that is 1 standard deviation above the US national average, and a 40 represents a score that is 1 standard deviation below the national average.
Measured: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
change in PROMIS 8b sleep disturbance scale
The sleep disturbance scale consists of 8 items that assess sleep quality with each item rated on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse sleep disturbance. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 60 represents a score that is 1 standard deviation above the US national average, and a 40 represents a score that is 1 standard deviation below the national average.
Measured: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
change in Roland Morris Disability scale
The Roland Morris disability scale is an assement of back pain specific disability based on the total number of items checked, ranging from a minimum of 0 to a maximum of 24, with higher scores indicating more disability.
Measured: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start3 Oct 2022
- Primary completion2 Mar 2026
- Study completion30 Mar 2026
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 Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- two groups, intervention and wait list control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah L. Krein, PhD RN, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423145
- Sponsor's protocol ID
- IIR 20-242
- Other IDs
- 1I01HX003302-01A2
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy SL, Zick SM, Harris RE, Smith SN, Sen A, Alexander NB, Caldararo J, Roman P, Firsht E, Belancourt P, Maciasz R, Perzhinsky J, Mitchinson A, Krein SL. Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial. Contemp Clin Trials. 2023 Jul;130:107232. doi: 10.1016/j.cct.2023.107232. Epub 2023 May 18.
PubMed 37207810
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Acupressure for Veterans With Chronic Back Pain: A Multisite Evaluation of Effectiveness and Implementation
- ClinicalTrials.gov ID
- NCT05423145
- Acronym / sponsor ID
- IIR 20-242
- Conditions
- Low Back Pain
- Keywords
- acupressure, complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 21 Jun 2022 (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.
Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain.
This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks.
Detailed description
This is a hybrid Type 1 effectiveness implementation study. The primary aim is to conduct a 2-group, randomized controlled trial to examine the effectiveness of stimulating acupressure compared to a waitlist control group for Veterans with chronic low back pain. Study participants will include Veterans Health Administration patients within the VA Ann Arbor Healthcare System who suffer from chronic low back pain and are interested in trying acupressure as a form of pain management. The second aim is to assess facilitators and barriers to implementing this type of acupressure program in VHA.
Specifically, this study will determine the effectiveness of a 6-week self-administered acupressure protocol on outcomes of pain interference, fatigue, sleep quality, and disability, at 6- and 10-weeks post baseline compared to a waitlist control group. The investigators hypothesize that outcomes will be improved from baseline for Veterans after 6 weeks of acupressure practice, and improvements will persist for the following 4 weeks. Intervention effects will be moderated by opioid use at baseline, age, sex, and baseline pain interference.
The study will recruit and enroll 300 Veterans with chronic low back pain, who will be randomized into one of two study arms: stimulating acupressure or a waitlist control group. These Veterans will be recruited in multiple ways, including through Whole Health classes offered at the study facilities, provider referral and proactive outreach, with potentially eligible participants identified using electronic health record data available through the VHA's Corporate Data Warehouse. All participants will attend an introductory acupressure class, conducted either virtually or in person, that provides a general overview of acupressure for chronic back pain, demonstrates how to find an acupressure point and how much pressure to apply.
After completing the consent process and a baseline survey, participants will be randomized to the acupressure intervention or waitlist control group. Participants will be allocated into groups in a 1:1 ratio by block randomization with mixed block sizes and stratified by sex to ensure balance of females and males across groups. Participants randomized to the intervention will then receive a tablet computer with an app that provides specific instructions on how to self-administer stimulating acupressure and identify acupressure points for treating back pain. Intervention participants will be asked to follow a 6-week protocol that involves performing acupressure once per day, for approximately 30 minutes, guided by the app. After 6 weeks, they will be asked to stop acupressure for 4 weeks so persisting effects can be determined. Participants in the waitlist control group will receive a tablet with the app at the end of 10 weeks. Survey based outcome assessments will be conducted at 6 weeks and 10 weeks.
The ultimate goal of this study is to identify effective and accessible non-pharmacological treatments for chronic pain, which are critically needed both inside and outside VHA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups, intervention and wait list control
| Arm | Type | Receives |
|---|---|---|
| acupressure intervention | Experimental | Behavioral: self-administered acupressureReceives access to the acupressure intervention |
| wait list control | No intervention | –No access to the acupressure intervention during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans enrolled at VA Ann Arbor Healthcare System
- non-specific low back pain confirmed through electronic medical records (i.e., ICD-10 codes: M54.5, M54.40, 41, 42, M54.89)
- reported pain severity of 4/10 that has persisted for at least 3 months and present on most days
- medically stable (no hospitalizations in the past month lasting 3 or more days)
- no changes in pain medication regimen in past 4 weeks
Key exclusion criteria (4 listed)
- pregnant
- had back surgery in the past 2 years
- received acupuncture or acupressure in past 3 months
- evidence of cognitive impairment that could interfere with the ability to provide consent and follow the study protocol (defined as a score of 3 using the Callahan et al. 6-item screener)
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 |
|---|---|---|
| self-administered acupressureThe acupressure intervention is self-administered. The intervention group receives an app that instructs them on how to perform a stimulating acupressure protocol, consisting of six acupoints with four of the acupoints performed on both the left and the right sides of the body for a total of ten points. Each of the ten acupoints is to be stimulated for 3 minutes per point for a total treatment time of 30 minutes daily for 6 weeks. | Behavioural | acupressure intervention |
Primary outcome
change in PROMIS 6b pain interference scale
Time frame: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
The Pain Interference Scale provides an assessment of the impact of pain on several aspects of functioning, including social and emotional processes as well as physical function (e.g., how much did pain interfere with your day to day activities) based on 6 items rated on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing greater interference (worse function). PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 60 represents a score that is 1 standard deviation above the US national average, and a 40 represents a score that is 1 standard deviation below the national average.
3 secondary outcomes
change in PROMIS 8a fatigue scale
Time frame: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
change in PROMIS 8b sleep disturbance scale
Time frame: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
change in Roland Morris Disability scale
Time frame: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
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 2 Apr 2026.
- Background: PubMed 37207810Murphy SL, Zick SM, Harris RE, Smith SN, Sen A, Alexander NB, Caldararo J, Roman P, Firsht E, Belancourt P, Maciasz R, Perzhinsky J, Mitchinson A, Krein SL. Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial. Contemp Clin Trials. 2023 Jul;130:107232. doi: 10.1016/j.cct.2023.107232. Epub 2023 May 18.
- 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.
Sarah L. Krein, PhD RN principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administered acupressure in people with Low Back Pain, run by VA Office of Research and Development at 1 site 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 6 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: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change in PROMIS 6b pain interference scale (time frame: baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)). 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 NCT05423145, 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 2 Apr 2026.