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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Frozen shoulder

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

Surface electromyography was used to collect the muscle activity of pectoralis major, teres major, infraspinatus, upper and lower trapezius

Timepoint [1]

Immediately before and after the muscle relaxation treatment

Primary outcome [2]

shoulder kinematics including shoulder flexion, scapular posterior tipping, and upward rotation were measured by Liberty electromagnetic tracking system

Timepoint [2]

Immediately before and after the muscle relaxation treatment

Secondary outcome [1]

shoulder active and passive range of motion in each directions (flexion, abduction, external and internal rotation) by an universal goniometer

Timepoint [1]

Immediately before and after the muscle relaxation treatment

Secondary outcome [2]

Shoulder muscle strength recorded by a hand-held dynanometer.

Timepoint [2]

Immediately before and after the muscle relaxation treatment

Secondary outcome [3]

Pain intensity assessed by visual analog scale (VAS)

Timepoint [3]

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]

Taiwan, Province Of China

State/province [1]

Taipei

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Nil

Address [1]

Nil

Country [1]

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]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Taipei City Hospital Institutional Review Board

Ethics committee address [1]

No.145, Zhengzhou Rd., Datong Dist., Taipei City 10341, Taiwan (R.O.C.)

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

08/07/2014

Approval date [1]

08/08/2014

Ethics approval number [1]

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

A/Prof 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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

Email

yfshih@ym.edu.tw

Contact person for public queries

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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

Email

yfshih@ym.edu.tw

Contact person for scientific queries

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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

Email

yfshih@ym.edu.tw

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

Source	Title	Year of Publication	DOI
Embase	The immediate effect of muscle release intervention on muscle activity and shoulder kinematics in patients with frozen shoulder: A cross-sectional, exploratory study.	2017	https://dx.doi.org/10.1186/s12891-017-1867-8

N.B. These documents automatically identified may not have been verified by the study sponsor.