Aromatase Inhibitor-Associated Musculoskeletal SyndromeAKUNCT07909785
AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome
A study testing Manual Acupuncture in people with Aromatase Inhibitor-Associated Musculoskeletal Syndrome and Arthralgia Syndrome, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial summary
Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome, Early Breast Cancer (EBC)
- What is being tested?
- Manual Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Oct 2021to 31 Mar 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary invasive hormone receptor-positive (HR+) breast cancer.
- Adjuvant therapy with a third-generation aromatase inhibitor (anastrozole, letrozole, or exemestane) for more than 3 months prior to study enrollment.
- Postmenopausal status, or premenopausal status under LHRH agonist therapy for > 30 days prior to study entry with an anticipated duration of use of at least another 1 year.
- ECOG Performance Status 0-2.
- Aromatase inhibitor-related multi-joint musculoskeletal pain with a baseline Brief Pain Inventory (BPI) pain score > 3 out of 10 (and a score ≥ 4 at screening visit).
- Signed written informed consent.
Who cannot join
- Prior acupuncture treatment within 12 months prior to study entry.
- Requirement for any ongoing analgesic therapy (NSAIDs, opioid analgesics, topical analgesics).
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) ≤ 7 days prior to enrollment and during the following 3 months.
- Regular use of psychotropic drugs, hypnotics, or sedatives.
- Acute infectious disease within the preceding 14 days.
- Use of antibiotics.
Show all 18Show fewer
- Chemotherapy, immunotherapy, or radiotherapy during the preceding 90 days.
- Anticoagulant therapy or underlying coagulation/bleeding disorders.
- Use of herbal remedies and dietary supplements 7 days before and 3 months after completion of acupuncture.
- Systemic or topical immunomodulatory therapy (oral, intramuscular, or intra-articular corticosteroids).
- Use of anticonvulsants (e.g., gabapentin, pregabalin).
- Bone fractures or orthopedic bone surgery within 12 months prior to enrollment.
- Other joint diseases or systemic conditions (e.g., rheumatoid arthritis).
- Inability to undergo needle insertion due to skin disorders.
- Use of alternative therapies.
- Known allergy to metals.
- Severe needle phobia.
- Any modification of endocrine therapy during the study period, including switching between different aromatase inhibitor agents (results in participant discontinuation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Aromatase Inhibitors-related Musculoskeletal Syndrome in Breast Cancer Patients
Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival.
The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory [BPI], Rheumatoid Arthritis Pain Scale [RAPS], Pittsburgh Sleep Quality Index [PSQI], and Hospital Anxiety and Depression Scale [HADS]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).
Read the detailed description
Background and Rationale: Adjuvant endocrine therapy with third-generation aromatase inhibitors (AIs; anastrozole, letrozole, or exemestane) significantly improves disease-free and overall survival in hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) develops in approximately 50% of treated patients, presenting as joint pain (arthralgia), morning stiffness, and restricted mobility, predominantly affecting the small joints of the hands and wrists. AIMSS is a leading cause of non-adherence or early treatment discontinuation, which has been directly correlated with reduced long-term overall survival. Standard management options (oral non-steroidal anti-inflammatory drugs, exercise) offer limited efficacy, and long-term use of systemic analgesics entails significant side effects. Manual acupuncture is a recommended non-pharmacological supportive care option (e.g., within NCCN guidelines), yet available clinical evidence remains limited by small sample sizes and methodological variability.
Study Design and Interventions: This is a prospective, randomized (1:1), open-label, parallel-group clinical trial enrolling 200 female patients experiencing AIMSS. Participants are stratified at baseline according to age (≤ 50, 51-64, > 65 years), ECOG performance status (0 vs. 1-2), and baseline Brief Pain Inventory (BPI) pain score (4-6 vs. 7-10).
Experimental Group (Arm I, n = 100): Participants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week intervention period. Acupuncture is administered by trained, licensed physicians according to STRICTA guidelines using sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) inserted at traditional depths. Mandatory bilateral needle stimulation is performed at 4 core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional optional points (e.g., ST36, BL60, KI3, PC6, CV6) may be selected based on individual clinical presentation and are systematically logged.
Control Group (Arm II, n = 100): Participants receive standard care without acupuncture and undergo functional testing and questionnaire completion on the exact same schedule as Arm I.
Visit Schedule and Patient Evaluations: Total participant involvement lasts 22 weeks across 4 primary evaluation milestones:
Baseline (Week 1 / Visit 1): Screening of inclusion/exclusion criteria, written informed consent, demographic data collection, baseline BPI pain assessment (threshold score ≥ 4 required), baseline patient-reported outcome questionnaires (RAPS, PSQI, HADS, HAQ), and objective upper-limb physical testing (Hand Grip Strength Test and Grip Ability Test).
Week 10 (Visit 10 for Arm I / Visit 2 for Arm II - End of Intervention): Primary assessment of pain reduction, muscle strength, dexterity, sleep quality, and psychological distress.
Week 14 (Visit 11 for Arm I / Visit 3 for Arm II - 4 Weeks Post-Intervention): Evaluation of early persistence of therapeutic relief and functional outcomes.
Week 22 (Visit 12 for Arm I / Visit 4 for Arm II - 3 Months Post-Intervention): Final study evaluation assessing long-term maintenance of treatment effect and study completion.
Safety Monitoring and Data Management: Adverse events associated with acupuncture (e.g., localized bleeding, infection, vasovagal collapse, periosteal/nerve irritation, fatigue, or temporary symptom exacerbation) are monitored at each treatment visit and at final follow-up. All clinical data are recorded in a validated electronic Case Report Form (eCRF) hosted on secure servers maintained by the CZECRIN research infrastructure, adhering to Good Clinical Practice (GCP) and GDPR guidelines.
- Conditions
- Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome, Early Breast Cancer (EBC)
- Being tested
- Manual Acupuncture
- Keywords
- Acupuncture, Aromatase Inhibitors, Aromatase Inhibitor-Induced Musculoskeletal Syndrome, Early Breast Cancer, Arthralgia, Adjuvant Endocrine Therapy
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual AcupunctureDevice
Participants undergo 10 weekly sessions of manual acupuncture lasting 20 minutes per session over a total period of 10 weeks. Acupuncture is administered by trained physicians in accordance with STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. Sterile, single-use ENERGY Wuxi Jiajian acupuncture needles (dimensions: 25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Each session requires mandatory bilateral stimulation of four core acupuncture points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, CV6, or other points) may be selected based on the participant's individual clinical presentation and are systematically recorded.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Acupuncture | Experimental | Participants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week period. Sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Mandatory bilateral needle stimulation is performed at four core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, and CV6) may be selected and documented based on individual clinical presentation. Participants complete patient-reported outcome questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo physical testing for hand grip strength and finger dexterity (Hand Grip Strength Test and Grip Ability Test) at Baseline (Week 1), Week 10, Week 14, and Week 22 (3 months post-intervention), across a total of 12 study visits. Receives: Device: Manual Acupuncture |
| Arm II: Control | No intervention | Participants receive standard care without acupuncture intervention. Participants complete the identical battery of questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo objective functional testing for hand grip strength and finger dexterity at the exact same time points as Arm I (Baseline, Week 10, Week 14, and Week 22). Total participation for Arm II comprises 5 study visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Brief Pain Inventory Short Form (BPI-SF)
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.
Measured: Baseline, Week 10, Week 14, and Week 22.
Change from Baseline in Upper Limb Muscle Strength as Assessed by the Hand Grip Strength Test (HGS)
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.
Measured: Baseline (Week 1), Week 10, Week 14, and Week 22.
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Rheumatoid Arthritis Pain Scale (RAPS)
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.
Measured: Baseline, Week 10, Week 14, and Week 22.
Change from Baseline in Finger Dexterity and Hand Function as Assessed by the Grip Ability Test (GAT)
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.
Measured: Baseline (Week 1), Week 10, Week 14, and Week 22.
Secondary outcomes (5)
Change from Baseline in Anxiety Score as Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
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.
Measured: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Change from Baseline in Overall Sleep Quality Score as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Durability and Duration of Pain Relief Post-Intervention as Assessed by Brief Pain Inventory Short Form (BPI-SF)
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.
Measured: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Number of Participants With Treatment-Related Adverse Events
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.
Measured: Continuously at each treatment session (Weeks 1 through 10) and at the final follow-up visit at Week 22.
Change from Baseline in Depression Score as Assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
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.
Measured: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start5 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aromatase Inhibitor-Associated Musculoskeletal SyndromeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, parallel-group trial. A total of 200 eligible participants are randomly allocated in a 1:1 ratio into two parallel groups: Arm I (Experimental - Acupuncture) and Arm II (Control - Standard Care / No Intervention). Electronic randomization is stratified using three baseline variables: Age (≤ 50 vs. 51-64 vs. \> 65 years), ECOG Performance Status (0 vs. 1-2), Baseline Brief Pain Inventory (BPI) pain score (4-6 vs. 7-10, calculated as the arithmetic mean of BPI questions 3-6). Participants in Arm I undergo 10 weekly 20-minute manual acupuncture sessions over 10 weeks, while participants in Arm II receive standard care without acupuncture. Both groups undergo identical questionnaire evaluations and physical performance assessments at Baseline, Week 10, Week 14, and Week 22.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909785
- Sponsor's protocol ID
- N55/21
- Acronym
- AKU
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Aromatase Inhibitors-related Musculoskeletal Syndrome in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07909785
- Acronym / sponsor ID
- AKU / N55/21
- Conditions
- Aromatase Inhibitor-Associated Musculoskeletal Syndrome, Arthralgia Syndrome, Early Breast Cancer (EBC)
- Keywords
- Acupuncture, Aromatase Inhibitors, Aromatase Inhibitor-Induced Musculoskeletal Syndrome, Early Breast Cancer, Arthralgia, Adjuvant Endocrine Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival.
The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory [BPI], Rheumatoid Arthritis Pain Scale [RAPS], Pittsburgh Sleep Quality Index [PSQI], and Hospital Anxiety and Depression Scale [HADS]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).
Detailed description
Background and Rationale: Adjuvant endocrine therapy with third-generation aromatase inhibitors (AIs; anastrozole, letrozole, or exemestane) significantly improves disease-free and overall survival in hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) develops in approximately 50% of treated patients, presenting as joint pain (arthralgia), morning stiffness, and restricted mobility, predominantly affecting the small joints of the hands and wrists. AIMSS is a leading cause of non-adherence or early treatment discontinuation, which has been directly correlated with reduced long-term overall survival. Standard management options (oral non-steroidal anti-inflammatory drugs, exercise) offer limited efficacy, and long-term use of systemic analgesics entails significant side effects. Manual acupuncture is a recommended non-pharmacological supportive care option (e.g., within NCCN guidelines), yet available clinical evidence remains limited by small sample sizes and methodological variability.
Study Design and Interventions: This is a prospective, randomized (1:1), open-label, parallel-group clinical trial enrolling 200 female patients experiencing AIMSS. Participants are stratified at baseline according to age (≤ 50, 51-64, > 65 years), ECOG performance status (0 vs. 1-2), and baseline Brief Pain Inventory (BPI) pain score (4-6 vs. 7-10).
Experimental Group (Arm I, n = 100): Participants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week intervention period. Acupuncture is administered by trained, licensed physicians according to STRICTA guidelines using sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) inserted at traditional depths. Mandatory bilateral needle stimulation is performed at 4 core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional optional points (e.g., ST36, BL60, KI3, PC6, CV6) may be selected based on individual clinical presentation and are systematically logged.
Control Group (Arm II, n = 100): Participants receive standard care without acupuncture and undergo functional testing and questionnaire completion on the exact same schedule as Arm I.
Visit Schedule and Patient Evaluations: Total participant involvement lasts 22 weeks across 4 primary evaluation milestones:
Baseline (Week 1 / Visit 1): Screening of inclusion/exclusion criteria, written informed consent, demographic data collection, baseline BPI pain assessment (threshold score ≥ 4 required), baseline patient-reported outcome questionnaires (RAPS, PSQI, HADS, HAQ), and objective upper-limb physical testing (Hand Grip Strength Test and Grip Ability Test).
Week 10 (Visit 10 for Arm I / Visit 2 for Arm II - End of Intervention): Primary assessment of pain reduction, muscle strength, dexterity, sleep quality, and psychological distress.
Week 14 (Visit 11 for Arm I / Visit 3 for Arm II - 4 Weeks Post-Intervention): Evaluation of early persistence of therapeutic relief and functional outcomes.
Week 22 (Visit 12 for Arm I / Visit 4 for Arm II - 3 Months Post-Intervention): Final study evaluation assessing long-term maintenance of treatment effect and study completion.
Safety Monitoring and Data Management: Adverse events associated with acupuncture (e.g., localized bleeding, infection, vasovagal collapse, periosteal/nerve irritation, fatigue, or temporary symptom exacerbation) are monitored at each treatment visit and at final follow-up. All clinical data are recorded in a validated electronic Case Report Form (eCRF) hosted on secure servers maintained by the CZECRIN research infrastructure, adhering to Good Clinical Practice (GCP) and GDPR guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, parallel-group trial. A total of 200 eligible participants are randomly allocated in a 1:1 ratio into two parallel groups: Arm I (Experimental - Acupuncture) and Arm II (Control - Standard Care / No Intervention). Electronic randomization is stratified using three baseline variables: Age (≤ 50 vs. 51-64 vs. > 65 years), ECOG Performance Status (0 vs. 1-2), Baseline Brief Pain Inventory (BPI) pain score (4-6 vs. 7-10, calculated as the arithmetic mean of BPI questions 3-6). Participants in Arm I undergo 10 weekly 20-minute manual acupuncture sessions over 10 weeks, while participants in Arm II receive standard care without acupuncture. Both groups undergo identical questionnaire evaluations and physical performance assessments at Baseline, Week 10, Week 14, and Week 22.
| Arm | Type | Receives |
|---|---|---|
| Arm I: Acupuncture | Experimental | Device: Manual AcupunctureParticipants undergo 10 weekly 20-minute sessions of manual acupuncture over a 10-week period. Sterile, single-use ENERGY Wuxi Jiajian needles (25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Mandatory bilateral needle stimulation is performed at four core points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, and CV6) may be selected and documented based on individual clinical presentation. Participants complete patient-reported outcome questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo physical testing for hand grip strength and finger dexterity (Hand Grip Strength Test and Grip Ability Test) at Baseline (Week 1), Week 10, Week 14, and Week 22 (3 months post-intervention), across a total of 12 study visits. |
| Arm II: Control | No intervention | –Participants receive standard care without acupuncture intervention. Participants complete the identical battery of questionnaires (BPI, RAPS, PSQI, HADS, and HAQ) and undergo objective functional testing for hand grip strength and finger dexterity at the exact same time points as Arm I (Baseline, Week 10, Week 14, and Week 22). Total participation for Arm II comprises 5 study visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed primary invasive hormone receptor-positive (HR+) breast cancer.
- Adjuvant therapy with a third-generation aromatase inhibitor (anastrozole, letrozole, or exemestane) for more than 3 months prior to study enrollment.
- Postmenopausal status, or premenopausal status under LHRH agonist therapy for > 30 days prior to study entry with an anticipated duration of use of at least another 1 year.
- ECOG Performance Status 0-2.
- Aromatase inhibitor-related multi-joint musculoskeletal pain with a baseline Brief Pain Inventory (BPI) pain score > 3 out of 10 (and a score ≥ 4 at screening visit).
Key exclusion criteria (18 listed)
- Prior acupuncture treatment within 12 months prior to study entry.
- Requirement for any ongoing analgesic therapy (NSAIDs, opioid analgesics, topical analgesics).
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) ≤ 7 days prior to enrollment and during the following 3 months.
- Regular use of psychotropic drugs, hypnotics, or sedatives.
- Acute infectious disease within the preceding 14 days.
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 |
|---|---|---|
| Manual AcupunctureParticipants undergo 10 weekly sessions of manual acupuncture lasting 20 minutes per session over a total period of 10 weeks. Acupuncture is administered by trained physicians in accordance with STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. Sterile, single-use ENERGY Wuxi Jiajian acupuncture needles (dimensions: 25×0.25 mm, 40×0.25 mm, 40×0.20 mm) are applied at traditional depths. Each session requires mandatory bilateral stimulation of four core acupuncture points: GB41, GB34, TE5, and LI4 (8 needles total). Additional points (such as ST36, BL60, KI3, PC6, CV6, or other points) may be selected based on the participant's individual clinical presentation and are systematically recorded. | Device | Arm I: Acupuncture |
Primary outcome
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Brief Pain Inventory Short Form (BPI-SF)
Time frame: 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.
Change from Baseline in Upper Limb Muscle Strength as Assessed by the Hand Grip Strength Test (HGS)
Time frame: 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.
Change from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Rheumatoid Arthritis Pain Scale (RAPS)
Time frame: 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.
Change from Baseline in Finger Dexterity and Hand Function as Assessed by the Grip Ability Test (GAT)
Time frame: 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.
5 secondary outcomes
Change from Baseline in Anxiety Score as Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Change from Baseline in Overall Sleep Quality Score as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Durability and Duration of Pain Relief Post-Intervention as Assessed by Brief Pain Inventory Short Form (BPI-SF)
Time frame: Baseline (Week 1), Week 10 (end of intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
Number of Participants With Treatment-Related Adverse Events
Time frame: Continuously at each treatment session (Weeks 1 through 10) and at the final follow-up visit at Week 22.
Change from Baseline in Depression Score as Assessed by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time frame: Baseline (Week 1), Week 10 (end of 10-week intervention), Week 14 (4 weeks post-intervention), and Week 22 (3 months post-intervention).
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture in people with Aromatase Inhibitor-Associated Musculoskeletal Syndrome and Arthralgia Syndrome, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
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 18 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 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 Czechia. 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?
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 from Baseline in Musculoskeletal Pain Severity Score as Assessed by the Brief Pain Inventory Short Form (BPI-SF) (time frame: Baseline, Week 10, Week 14, and Week 22.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.