UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052590 |
|---|---|
| Receipt number | R000060011 |
| Scientific Title | Investigation of Factors Affecting the Therapeutic Effectiveness of Mirror Therapy for Shoulder Pain : A Randomized Crossover Trial |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2024/01/31 20:34:18 |
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Basic information
Public title
Investigation of Factors Affecting the Therapeutic Effectiveness of Mirror Therapy for Shoulder Pain : A Randomized Crossover Trial
Acronym
Investigation of Factors Affecting the Therapeutic Effectiveness of Mirror Therapy for Shoulder Pain
Scientific Title
Investigation of Factors Affecting the Therapeutic Effectiveness of Mirror Therapy for Shoulder Pain : A Randomized Crossover Trial
Scientific Title:Acronym
Investigation of Factors Affecting the Therapeutic Effectiveness of Mirror Therapy for Shoulder Pain
Region
| Japan |
Condition
Condition
shoulder pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors that influence the therapeutic efficacy of mirror therapy for shoulder pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective pain intensity during automatic flexion of the shoulder joint (Numerical Rating Scale: NRS)
Key secondary outcomes
Subjective pain intensity at rest
Mirrored-limb perception questionnaire
Pressure pain threshold
Fear during active flexion movements
Active flexion range of motion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
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
| Maneuver |
Interventions/Control_1
Mirror Therapy
10 minute
Interventions/Control_2
Control intervention (mirror covered condition)
10 minute
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pain of NRS:3 or greater during automatic shoulder flexion on either the anterior or lateral side of the shoulder on one side that has persisted for at least 4 weeks.
Key exclusion criteria
Pain complaint on the nonaffected shoulder with NRS:1 or greater and limited range of motion in automatic flexion compared to the affected shoulder.
Shoulder joint range of motion on the affected side is less than 100 of external flexion 10 of external rotation and L5 of internal rotation.
Bilateral shoulder surgery on either side.
History of total rotator cuff tear.calcific rotator cuff inflammation fracture osteonecrosis osteoarthritis or dislocation.
Pain or numbness by Spurling's test or upper limb tension test
History of autoimmune diseases (rheumatoid arthritis systemic lupus erythematosus) neurological diseases (Parkinson's disease spinocerebellar degeneration) fibromyalgia complex regional pain syndrome psychiatric diseases
Intra-articular corticosteroid injections within 3 months of study entry.
Target sample size
70
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-tyou, Mihara, Hiroshima
TEL
0848-60-1120
tomon@pu-hirosima.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Ogawa |
Organization
Hayashi Hospital
Division name
Department of Rehabilitation
Zip code
730-0029
Address
3-8 Mikawacho, Nakaku, Hiroshima City, Hiroshima Prefecture
TEL
082-248-0600
Homepage URL
taku62016201@yahoo.co.jp
Sponsor or person
Institute
Hayashi Hospital
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-tyou, Mihara, Hiroshima
Tel
0848-60-1120
tomon@pu-hirosima.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
| 2023 | Year | 10 | Month | 24 | 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
0
Results
The study title and protocol were revised and the study was discontinued
Results date posted
| 2024 | Year | 01 | Month | 31 | Day |
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
Terminated
Date of protocol fixation
| 2023 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060011
