Trial · NCT07909785
AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome
NCT07909785, Not applicable, Active not recruiting, Masaryk Memorial Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome. Trials, record NCT07909785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome
- NCT number
- NCT07909785
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Conditions
- Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome, Early Breast Cancer (EBC)
- Interventions
- Manual Acupuncture
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Brief Pain Inventory Short Form (BPI-SF) | Baseline, Week 10, Week 14, and Week 22. | Musculoskeletal pain severity is evaluated using the Brief Pain Inventory Short Form (BPI-SF) pain severity score, calculated as the arithmetic mean of items 3 through 6 (worst pain, least pain, average pain, and pain right now in the last 24 hours). The pain severity score ranges from 0 to 10, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Higher scores indicate greater pain severity (worse outcome). Change is calculated as the post-baseline score minus the baseline score. |
| Primary | Change from Baseline in Upper Limb Muscle Strength as Assessed by the Hand Grip Strength Test (HGS) | Baseline (Week 1), Week 10, Week 14, and Week 22. | Upper limb muscle strength will be objectively evaluated using the Hand Grip Strength Test (HGS). Muscle strength is measured in kilograms (kg) and calculated as the arithmetic mean of 3 consecutive measurements on the dominant/tested arm. Higher values indicate greater muscle strength (better outcome). Change is calculated as post-baseline value minus baseline value. |
| Primary | Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Rheumatoid Arthritis Pain Scale (RAPS) | Baseline, Week 10, Week 14, and Week 22. | Musculoskeletal pain severity is evaluated using the Rheumatoid Arthritis Pain Scale (RAPS) questionnaire, a 24-item self-report questionnaire assessing pain across physiological, affective, sensory, and cognitive dimensions. Each item is scored on a 0 to 6 scale (0 = Never, 6 = Always), yielding a total score ranging from 0 to 144. Higher scores indicate greater pain severity and pain impact (worse outcome). Change is calculated as the post-baseline score minus the baseline score. |
| Primary | Change from Baseline in Finger Dexterity and Hand Function as Assessed by the Grip Ability Test (GAT) | Baseline (Week 1), Week 10, Week 14, and Week 22. | Finger dexterity and upper limb coordination will be objectively evaluated using the Grip Ability Test (GAT). The test measures the time required in seconds to complete standard functional hand tasks (such as putting a Tubigrip sock on a item, attaching a paperclip to an envelope, and pouring water from a pitcher). Lower values (shorter time in seconds) indicate better dexterity and hand function (better outcome). Change is calculated as post-baseline value minus baseline value. |
| Secondary | Change from Baseline in Anxiety Score as Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention). | Psychological anxiety will be evaluated using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items scored on a 4-point Likert scale (0 to 3), yielding a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity (worse outcome). Change is calculated as post-baseline score minus baseline score. |
| Secondary | Change from Baseline in Overall Sleep Quality Score as Assessed by the Pittsburgh Sleep Quality Index (PSQI) | Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention). | Sleep quality and sleep disturbances will be evaluated using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The PSQI assesses sleep quality over a 1-month time interval through 19 individual items grouped into 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). Each component is scored from 0 to 3, yielding a total Global PSQI Score ranging from 0 to 21. Higher scores indicate poorer sleep quality and greater sleep disturbance (worse outcome). Change is calculated as the post-baseline score minus the baseline score. |
| Secondary | Durability and Duration of Pain Relief Post-Intervention as Assessed by Brief Pain Inventory Short Form (BPI-SF) | Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention). | Evaluates the persistence and duration of therapeutic pain relief following the completion of the 10-week intervention. Pain severity is assessed using the Brief Pain Inventory Short Form (BPI-SF) pain severity score (range 0 to 10, where higher scores indicate worse pain) across post-intervention follow-up visits (Week 14 and Week 22) compared to Week 10 to determine the maintenance of pain reduction over time. |
| Secondary | Number of Participants With Treatment-Related Adverse Events | Continuously at each treatment session (Weeks 1 through 10) and at the final follow-up visit at Week 22. | Safety and tolerability of the acupuncture intervention will be evaluated by monitoring the incidence, type, severity, and potential causality of adverse events. Tracked events include localized bleeding, site infection, vasovagal collapse, nerve or periosteal irritation, increased fatigue, and transient symptom exacerbation. The outcome will report the number of participants experiencing one or more treatment-related adverse events. |
| Secondary | Change from Baseline in Depression Score as Assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) | Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention). | Psychological depression and mood will be evaluated using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items scored on a 4-point Likert scale (0 to 3), yielding a total score ranging from 0 to 21. Higher scores indicate greater depression severity (worse outcome). Change is calculated as post-baseline score minus baseline score. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07909785
GET https://conductscience.org/api/trials/v1/NCT07909785/registered