UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056519 |
|---|---|
| Receipt number | R000063467 |
| Scientific Title | Effects of a combined intervention of physiotherapy and personalized learning Pain Science Education (pPSE) on persistent post-breast cancer surgical pain |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/02/26 06:37:28 |
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Basic information
Public title
Effect of a Combined intervention Patient Education Using Smartphones and Physiotherapy on Post-Breast Cancer Surgery Pain
Acronym
Effect of a Combined Patient Education and Physiotherapy on Post-Breast Cancer Surgery Pain
Scientific Title
Effects of a combined intervention of physiotherapy and personalized learning Pain Science Education (pPSE) on persistent post-breast cancer surgical pain
Scientific Title:Acronym
Effects of a combined intervention of physical therapy and personalized learning Pain Science Education (pPSE) on persistent post-breast cancer surgical pain
Region
| Japan |
Condition
Condition
Persistent post-breast cancer surgical pain
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether physical therapy combined with personalized learning Pain Science Education (pPSE) is effective in improving pain intensity and disability in patients with persistent post-breast cancer surgical pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale(VAS) at 3 months after start
Key secondary outcomes
Disability, health-related QOL, central sensitization, cost-effectiveness, psychological symptoms, physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Combined intervention of personalized learning pain science education and physiotherapy
Interventions/Control_2
Combined intervention of pain science education and physiotherapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) More than 1 year after surgery
2) VAS 30 (maximum in the past week) more in the operated upper limb
Key exclusion criteria
1) Specific pain-related symptoms (rheumatic diseases, history of orthopedic surgery, severe osteoarthritis)
2) Cancer treatment-related pain other than post-sursical pain (e.g. CIPN, AIMSS)VAS 30 more.
3) Bilateral breast cancer
4) Metastasis or recurrent breast cancer
5) Previous PSE intervention
Target sample size
48
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
723-0053
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, 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
| 2025 | Year | 01 | Month | 01 | 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
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063467
