UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045080 |
|---|---|
| Receipt number | R000051483 |
| Scientific Title | Adduction manipulation of the glenohumeral joint vs. physiotherapy for degenerative rotator cuff tears. |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2021/08/06 14:43:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Adduction manipulation of the glenohumeral joint vs. physiotherapy for degenerative rotator cuff tears.
Acronym
Utility of adduction manipulation for degenerative rotator cuff tears
Scientific Title
Adduction manipulation of the glenohumeral joint vs. physiotherapy for degenerative rotator cuff tears.
Scientific Title:Acronym
Utility of adduction manipulation for degenerative rotator cuff tears
Region
| Japan |
Condition
Condition
Degenerative rotator cuff tears
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare clinical outcomes between adduction manipulation and physiotherapy with a randomized controlled study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The American Shoulder and Elbow Surgeons (ASES) and Constant scores at the initial baseline visit and at the 1-, 3-, 6-, and 12- month follow-ups.
Key secondary outcomes
The visual analog scale (VAS), range of motion (ROM; such as flexion, abduction, external rotation, and internal rotation) at the initial baseline visit and at the 1-, 3-, 6-, and 12- month follow-ups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform an adduction manipulation for the shoulder joint after diagnosis by MRI.
Interventions/Control_2
Perform standard physiotherapy by two physical therapists, as a specialist for shoulder disorders.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Between April 2017 and March 2019, we enrolled patients in the trial, who complained of shoulder joint pain and presented rotator cuff tears with magnetic resonance imaging (MRI).
2) The inclusion criteria for patients with symptomatic degenerative rotator cuff tears were persistent symptoms for less than 6 months and normal radiologic appearance.
Key exclusion criteria
The exclusion criteria were an acute injury, already having undergone nonoperative or surgical treatment, substantial cervical pathology or radiculopathy, concomitant pathology of the affected shoulder (including instability, dislocation, acromioclavicular osteoarthritis, and scapular dyskinesia), systemic inflammation, and metabolic disorders such as rheumatoid arthritis and diabetes mellitus.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Hamada |
Organization
Kuwano Kyoritsu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
963-8034
Address
2-9-18 Shima, Koriyama, Fukushima, Japan
TEL
024-933-5422
i-hamada@koriyama-h-coop.or.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Hamada |
Organization
Kuwano Kyoritsu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
963-8034
Address
2-9-18 Shima, Koriyama, Fukushima, Japan
TEL
024-933-5422
Homepage URL
i-hamada@koriyama-h-coop.or.jp
Sponsor or person
Institute
Kuwano Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Kuwano Kyoritsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Josai International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kuwano Kyoritsu Hospital
Address
2-9-18 Shima, Koriyama, Fukushima, 963-8034, Japan
Tel
024-933-5422
sei_ojimaa@koriyama-h-coop.or.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
| 2021 | Year | 08 | Month | 06 | 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
159
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051483
