UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049035 |
|---|---|
| Receipt number | R000055679 |
| Scientific Title | Randomized trial of combined intervention of pain neuroscience education and patient-led goal setting approach for aromatase inhibitor-induced musculoskeletal symptoms |
| Date of disclosure of the study information | 2022/10/16 |
| Last modified on | 2023/01/26 13:22:02 |
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Basic information
Public title
Effectiveness of combined exercise program and educational intervention for musculoskeletal symptoms (arthralgia, myalgia, stiffness) caused by hormone therapy
Acronym
Effectiveness of combined exercise program and educational intervention for musculoskeletal symptoms caused by hormone therapy
Scientific Title
Randomized trial of combined intervention of pain neuroscience education and patient-led goal setting approach for aromatase inhibitor-induced musculoskeletal symptoms
Scientific Title:Acronym
Effects of a Combined Pain Education and Goal-Setting Approach Intervention on Aromatase Inhibitor-Induced Musculoskeletal Symptoms -Randomized controlled trial-
Region
| Japan |
Condition
Condition
Aromatase inhibitor-induced musculoskeletal symptoms (AIMSS)
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study whether combined pain education and goal-setting approach intervention for breast cancer survivors with AIMSS is more effective than conventional exercise therapy in reducing pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Brief Pain Inventory intensity (worst) at 12 months after start
Key secondary outcomes
Central Sensitization Inventory-9
Quantitative Sensory Testing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Combined intervention of pain neuroscience education and goal setting approach
3 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Hormone receptor-positive clinical stage I-III breast cancer
(2)Duration of AI treatment for more than 6 months
(3)Onset of Pain or Stiffness after AI treatment
(4) BPI intensity (worst pain)3 or more in the past week, pain or stiffness lasting more than 3 months
(5)Moderate aerobic exercise less than 90 min per week and no strength training twice a week.
Key exclusion criteria
(1) Specific pain-related symptoms (neuropathic pain, rheumatic diseases, history of orthopedic surgery, severe osteoarthritis, inflammatory diseases, fibromyalgia)
(2) Recurrence of cancer
(3) Restricted from exercising by doctor.
(4) Having received form of PNE in the past.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishigami |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-053
Address
1-1 Gakuen-cho, Mihara, Hiroshima
TEL
0848-60-1120
tomon@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Manfuku |
Organization
Breast Care Sensyu Clinic
Division name
Department of Rehabilitation
Zip code
596-0076
Address
2-17-11 Noda-cho, Kishiwada-shi, Osaka
TEL
072-430-0811
Homepage URL
sunday_attinente@yahoo.co.jp
Sponsor or person
Institute
Breast Care Sensyu Clinic
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara, Hiroshima
Tel
0848-60-1120
tomon@pu-hiroshima.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055679
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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