Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00241228 | Other Identifier | University of Michigan | |
| BCRF-23-206 | Other Grant/Funding Number | Breast Cancer Research Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure Arm 1 | Other | There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point with the AcuWand giving a total treatment time of 27 minutes daily. The relaxation acupoints are unlisted in order to maintain blinding. |
|
| Acupressure Arm 2 | Other | There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes daily. The acupoints are unlisted in order to maintain blinding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Other | 9 acupoints will be stimulated for 3 minutes per point |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in joint pain | Range 0-10 after 12 weeks of intervention. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Comparison of baseline and 12 week assessment. | baseline and 12 weeks after intervention is started |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least a 2 point reduction in pain (worst) | The proportion of patients who have at least a 2-point reduction in worst pain from baseline to 12 weeks will be reported with the corresponding exact binomial confidence intervals in each treatment group. The proportions will be compared using a chi-square test for each outcome. Differences from baseline at each time point for worst pain will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in worst pain over time between groups similar to the primary endpoint. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norah Henry | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39841658 | Derived | Henry NL, Kidwell KM, Kozar S, Snyder S, Zick SM. Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial. PLoS One. 2025 Jan 22;20(1):e0311044. doi: 10.1371/journal.pone.0311044. eCollection 2025. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
researchers can request data once the primary analysis has been published
deidentified data will be available to researchers upon reasonable request
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2026 | |
| Reset | Jun 16, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2026 | Jun 16, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Participants will be randomized 1:1 to two different sets of acupressure points
Not provided
Not provided
Both clinicians and participants will be blinded to study arm.
| Acupressure |
| Other |
9 areas will be stimulated for 3 minutes per point |
|
| baseline and 12 weeks after intervention is started |
| Proportion of patients with at least a 2 point reduction in pain (average) | The proportion of patients who have at least a 2-point reduction in average pain from baseline to 12 weeks will be reported with the corresponding exact binomial confidence intervals in each treatment group. The proportions will be compared using a chi-square test for each outcome. Differences from baseline at each time point for worst pain will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in average pain over time between groups similar to the primary endpoint. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. | baseline and 12 weeks after intervention is started |
| Difference from baseline for pain interference | Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Differences from baseline at each time point for pain interference (range 0-10) will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in pain interference over time between groups similar to the primary endpoint. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in reported sleep disturbance | PROMIS Profile 29- sleep disturbance [range 32-73.3]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in reported fatigue | PROMIS Profile 29-fatigue [range 33.7-75.8]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in reported physical function | PROMIS Profile 29 -physical function [range 22.5-57]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in anxiety | PROMIS Profile 29-anxiety [range 40.3-81.6].Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in depression | PROMIS Profile 29-depression [range 41-79.4]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Change in cognitive function | PROMIS Profile 29-cognitive function [range 29.4-61.2]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome. | baseline, 6 weeks and 12 weeks after intervention is started |
| Adherence to trial intervention (number of days completed) | Adherence will be calculated based on number of days acupressure is performed The proportion of participants who are fully adherent will be compared between groups using a chi-square test. | 12 weeks after intervention is started |
| Adherence to trial intervention (number of minutes completed) | Adherence will be calculated based on number of minutes of acupressure performed each day. The proportion of participants who are fully adherent will be compared between groups using a chi-square test. | 12 weeks after intervention is started |
| safety of the intervention through reported adverse events | collected using CTCAE version 5.0 | 12 weeks after intervention is started |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |