Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001584820
Ethics application status
Approved
Date submitted
6/01/2021
Date registered
19/11/2021
Date last updated
19/11/2021
Date data sharing statement initially provided
19/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alterations in central excitability and biomechanical characteristics of the shoulder complex in patients with frozen shoulder
Scientific title
Comparing patients with and without frozen shoulder to finding the differences in muscle activities, scapular kinematics, muscle tone, central excitability
Secondary ID [1] 303103 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frozen shoulder 320195 0
Condition category
Condition code
Musculoskeletal 318140 318140 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 320729 320729 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants attended a 4-hour session involving four tests performed by a well-trained physiotherapist once only:
1. Muscle tone: used myotonometer to evaluate the muscle tone of the upper trapezius, infraspinatus, and pectoralis major. 20 minutes.
2. Muscle activities: evaluated the muscle activities by surface electromyography of the upper trapezius, infraspinatus, and pectoralis major during arm elevation, hand to neck and hand to back. 30 minutes.
3. Scapular kinematics: evaluated the scapular movement by magnetic tracking system during arm elevation, hand to neck, and hand to back. 30 minutes
4. Central excitability: the active motor threshold, motor evoked potential, cortical silent period, short-interval intracortical inhibition, and short-interval intracortical facilitation of upper trapezius, infraspinatus, and pectoralis major were measured by transcranial magnetics stimulation (TMS). 150 minutes.
Intervention code [1] 319406 0
Early Detection / Screening
Comparator / control treatment
The control group will be healthy people without shoulder pain.
Control group
Active

Outcomes
Primary outcome [1] 326117 0
central excitability assessed by transcranial magnetic stimulation (TMS)
Timepoint [1] 326117 0
After the evaluation of muscle tone
Secondary outcome [1] 390189 0
muscle tone assessed by myotonometer device
Timepoint [1] 390189 0
immediately after history taking and demographic data collection
Secondary outcome [2] 390190 0
muscle activities assessed by surface electromyography
Timepoint [2] 390190 0
immediately after central excitability evaluation
Secondary outcome [3] 390191 0
scapular kinematics assessed by magnetic tracking system
Timepoint [3] 390191 0
immediately after central excitability evaluation

Eligibility
Key inclusion criteria
The frozen shoulder group:
1. 40-65 y/o
2. Medical diagnosis of frozen shoulder
3. Pain and stiffness over the affected shoulder greater than or equal to 6 months
4. No resting pain or night pain
5. Range of motion (ROM) limitation of a shoulder joint (ROM decreased more than 25% in at least two directions, and ROM decreased more than 50% or less than 30° in passive external rotation)

The healthy control group:
1. Age, gender matched with the frozen shoulder group
2. Without shoulder pain or ROM limitation
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of surgery or fracture of the shoulder complex
2. Shoulder joint dislocation
3. Rheumatoid arthritis, diabetes mellitus, rotator cuff tear, calcification tendonitis, osteoarthritis, cervical radiculopathy, or shoulder ROM limitation due to stroke or spinal cord injury
4. Contraindications for transcranial magnetic stimulation (TMS)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
Actual
11/05/2021
Date of last data collection
Anticipated
Actual
11/05/2021
Sample size
Target
60
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 23357 0
Taiwan, Province Of China
State/province [1] 23357 0

Funding & Sponsors
Funding source category [1] 307507 0
Self funded/Unfunded
Name [1] 307507 0
Nil
Country [1] 307507 0
Primary sponsor type
Individual
Name
Yi-fen Shih
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 310354 0
None
Name [1] 310354 0
Nil
Address [1] 310354 0
Nil
Country [1] 310354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307580 0
Institutional Review Board (IRB) of National Yang-Ming University
Ethics committee address [1] 307580 0
Ethics committee country [1] 307580 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 307580 0
Approval date [1] 307580 0
21/07/2020
Ethics approval number [1] 307580 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107746 0
Prof Yi-Fen Shih
Address 107746 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 107746 0
Taiwan, Province Of China
Phone 107746 0
+886 2 28267340
Fax 107746 0
Email 107746 0
[email protected]
Contact person for public queries
Name 107747 0
Yi-Fen Shih
Address 107747 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 107747 0
Taiwan, Province Of China
Phone 107747 0
+886 2 28267340
Fax 107747 0
Email 107747 0
[email protected]
Contact person for scientific queries
Name 107748 0
Yi-Fen Shih
Address 107748 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 107748 0
Taiwan, Province Of China
Phone 107748 0
+886 2 28267340
Fax 107748 0
Email 107748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.