UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040855 |
|---|---|
| Receipt number | R000046649 |
| Scientific Title | A prospective study of selective nerve block and individualized rehabilitation for the frozen shoulder |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2020/06/22 17:53:33 |
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Basic information
Public title
A prospective study of selective nerve block and individualized rehabilitation for the frozen shoulder
Acronym
A prospective study of selective nerve block and individualized rehabilitation for the frozen shoulder
Scientific Title
A prospective study of selective nerve block and individualized rehabilitation for the frozen shoulder
Scientific Title:Acronym
A prospective study of selective nerve block and individualized rehabilitation for the frozen shoulder
Region
| Japan |
Condition
Condition
Frozen shoulder
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of selective nerve block and rehabilitation on frozen shoulders with conventional intra-articular injection treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Quick DASH score (JSSH version) up to 8 weeks after treatment intervention.
Key secondary outcomes
Shoulder range of motion, pain intensity (visual analog scale), analgesic usage, treatment satisfaction (visual analog scale), muscle elasticity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
selective nerve block(Once a week for up to 4 weeks)
Interventions/Control_2
intra-articular injection(Once a week for up to 4 weeks)
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with frozen shoulders diagnosed as frozen stage.
(1) Frozen shoulder diagnostic criteria
1. Shoulder pain and contracture of the shoulder joint in more than one direction (flexion 90 degrees or less, external rotation 30 degrees or less, or internal sacrum or less)
2. Excludes organic diseases such as calcareous rotator cuff inflammation and rotator cuff tear using X-ray/MRI/echo.
(2) Diagnostic criteria for frozen stage
1. Within 3 months of onset.
2. Assessed pain intensity with visual analog scale is less than 30.
3. The contracture remains.
Key exclusion criteria
(1) Patients with a history of trauma or other shoulder disease
(2) Patients with a history of diabetes
(3) Patients with a history of thyroid disease
(4) Patients with mental illness
(5) Patients who are allergic to local anesthetics
(6) Patients participating in other studies
(7) Patients who are not qualified by the doctor in charge
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba, Sendai, Miyagi, 980-8574 Japan
TEL
022-717-7321
anes@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Norifumi |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba, Sendai, Miyagi, 980-8574 Japan
TEL
022-717-7321
Homepage URL
anes@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Perioperative Medicine,Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, AMED.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
東北大学病院（宮城県）
水谷痛みのクリニック（静岡県）
環状通東整形外科（北海道）
麻生整形外科病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046649
