Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000031460
Ethics application status
Approved
Date submitted
24/11/2015
Date registered
18/01/2016
Date last updated
18/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of muscle release technique on muscle activity and associated shoulder kinematics in patients with frozen shoulder
Scientific title
In patients with frozen shoulder, what is the effect of muscle release technique on shoulder muscle activity and shoulder kinematics and the relationship among the two?
Secondary ID [1] 287956 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frozen shoulder 296833 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297061 297061 0 0
Physiotherapy
Musculoskeletal 297062 297062 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Frozen shoulder patients first received thermotherapy, a electrical heating pad was applied on the shoulder region for 15 minutes. Patients with frozen shoulder could control the heating temperature by themselves. After the thermotherapy followed by one-session muscle release treatment for about 30 minutes right after the pre-test examination. There was a single 45-minute treatment session only. All treatments were done by a licensed physical therapist with at least 2 years of clinical experience. The target muscle was positioned in the lengthen position, while physical therapist gave a sustain pressure directly on the muscle belly for 60 to 90 seconds. This intervention mainly focused on pectoralis major, upper trapezius, infraspinatus, teres major and posterior deltoid. There was no any strategy used to monitor the intervention.
Intervention code [1] 293313 0
Rehabilitation
Intervention code [2] 293398 0
Treatment: Other
Comparator / control treatment
The healthy control subjects were recruited in this study in order to compare the baseline data of the shoulder muscle activity and shoulder kinematics with patients with frozen shoulder.
Control group
Active

Outcomes
Primary outcome [1] 296682 0
Surface electromyography was used to collect the muscle activity of pectoralis major, teres major, infraspinatus, upper and lower trapezius
Timepoint [1] 296682 0
Immediately before and after the muscle relaxation treatment
Primary outcome [2] 296683 0
shoulder kinematics including shoulder flexion, scapular posterior tipping, and upward rotation were measured by Liberty electromagnetic tracking system
Timepoint [2] 296683 0
Immediately before and after the muscle relaxation treatment
Secondary outcome [1] 319113 0
shoulder active and passive range of motion in each directions (flexion, abduction, external and internal rotation) by an universal goniometer
Timepoint [1] 319113 0
Immediately before and after the muscle relaxation treatment
Secondary outcome [2] 319114 0
Shoulder muscle strength recorded by a hand-held dynanometer.
Timepoint [2] 319114 0
Immediately before and after the muscle relaxation treatment
Secondary outcome [3] 319115 0
Pain intensity assessed by visual analog scale (VAS)
Timepoint [3] 319115 0
Immediately before and after the muscle relaxation treatment

Eligibility
Key inclusion criteria
Inclusion criteria for patient group including (1) Diagnosed with frozen shoulder or at least a 25% limitation on shoulder passive range of motion in at least two directions (glenohumeral joint flexion, abduction, external and internal rotation), (2) pain and stiffness over the affected shoulder region > 3months, (3) no resting pain or night pain in the affected shoulder region, and willing to participate in this study. Asymptomatic subjects were recruited from personal contacts and age, gender, BMI, and tested shoulder matched with frozen shoulder subject.
Minimum age
43 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusive criteria for all subjects were: (1) history of a surgery or fracture of the shoulder complex, (2) shoulder joint dislocation, (3) rheumatoid arthritis, (4) osteoarthritis of the particular shoulder joint, (5) cervical radiculopathy, or (6) shoulder ROM limitation due to stroke or spinal cord injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
17/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7353 0
Taiwan, Province Of China
State/province [1] 7353 0
Taipei

Funding & Sponsors
Funding source category [1] 292439 0
Self funded/Unfunded
Name [1] 292439 0
Nil
Country [1] 292439 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] 291132 0
None
Name [1] 291132 0
Nil
Address [1] 291132 0
Nil
Country [1] 291132 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293898 0
Taipei City Hospital Institutional Review Board
Ethics committee address [1] 293898 0
No.145, Zhengzhou Rd., Datong Dist., Taipei City 10341, Taiwan (R.O.C.)
Ethics committee country [1] 293898 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 293898 0
08/07/2014
Approval date [1] 293898 0
08/08/2014
Ethics approval number [1] 293898 0
TCHIRB-1030708-E

Summary
Brief summary
The purposes of this study are to compare differences in shoulder muscle activity and kinematics between patients with frozen shoulder and matched healthy subjects; and to determine the effects of one-session muscle release techniques on shoulder muscle activity and shoulder kinematics. 20 patients with unilateral frozen shoulder and 20 asymptomatic subjects were recruited. All subjects received pre-test examination including shoulder kinematics, range of motion and muscle strength, pain scale, and electromyography of pectoralis major(PM), infraspinatus(IS), teres major(TM), upper trapezius(LT), and lower trapezius(LT). The data of shoulder muscle activity and kinematics were recorded during scaption, hand to neck and thumb to waist. Patients then received one-session muscle release treatment and the post-test examination immediately. Compared to the asymptomatic controls, the patients with frozen shoulder revealed significantly decreased LT and IS muscle activity , and increased PM activity during functional tasks. After one-session of muscle release treatment, both UT and LT muscle activity improved during shoulder elevation. The TM muscle activity decreased 4.38% (p=0.033) which was closer to the level of the asymptomatic controls. In addition, the angle of shoulder flexion (SF), scapular posterior tilt (PT) and upward rotation (UR) were significantly decreased in patient group, and after one-session of intervention, scapular posterior tilt was improved 3.14 degree during shoulder elevation. Conclusion: Patients with frozen shoulder showed abnormal muscle activity and shoulder kinematics during three functional tasks. After one-session of muscle release techniques, the abnormal muscle activity was normalized accompanying with improved scapular kinematics. Clinical Relevance: The abnormal shoulder muscle activity, especially of the trapezius muscles, may contribute to abnormal scapular dynamic control in patients with frozen shoulder and may influence functional movements in their daily life.
Trial website
Trial related presentations / publications
This study has not published.
Public notes

Contacts
Principal investigator
Name 61218 0
A/Prof Yi-Fen Shih
Address 61218 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 61218 0
Taiwan, Province Of China
Phone 61218 0
+886 2 2826 7340
Fax 61218 0
+886 2 2820 1841
Email 61218 0
[email protected]
Contact person for public queries
Name 61219 0
A/Prof Yi-Fen Shih
Address 61219 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 61219 0
Taiwan, Province Of China
Phone 61219 0
+886 2 2826 7340
Fax 61219 0
+886 2 2820 1841
Email 61219 0
[email protected]
Contact person for scientific queries
Name 61220 0
A/Prof Yi-Fen Shih
Address 61220 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 61220 0
Taiwan, Province Of China
Phone 61220 0
+886 2 2826 7340
Fax 61220 0
+886 2 2820 1841
Email 61220 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe immediate effect of muscle release intervention on muscle activity and shoulder kinematics in patients with frozen shoulder: A cross-sectional, exploratory study.2017https://dx.doi.org/10.1186/s12891-017-1867-8
N.B. These documents automatically identified may not have been verified by the study sponsor.