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Trial registered on ANZCTR


Registration number
ACTRN12617001234303
Ethics application status
Approved
Date submitted
26/02/2017
Date registered
23/08/2017
Date last updated
24/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prognostic factors for the effect of motor control training combined with myofascial trigger point therapy for patients with subacromial impingement syndrome
Scientific title
Prognostic factors for the effect of motor control training combined with myofascial trigger point therapy for patients with subacromial impingement syndrome
Secondary ID [1] 291282 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder impingement 302230 0
Condition category
Condition code
Musculoskeletal 301828 301828 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Motor control training combined with MTrP therapy include (1) manual compression on MTrPs of shoulder muscles (levator scapulae, pectoralis minor, infraspinatus, teres minor, trapezius, rhomboids), each point for 30-60 sec, 2-3 repetitions. MTrP treatment was administered by each patient's physical therapist. (2) Immediately after the MTrp treatment, shoulder range of motion exercise with stretching to achieve maximum painfree shoulder flexion, abduction, internal and external rotation was performed. (3) Shoulder motor control retraining: Patients were instructed to maintain a scapular neutral position and consequently taught to find the neutral position themselves. Patients were shown and told to avoid several incorrect muscle activation strategies. The patient was asked to control the orientation of the scapula whilst performing arm flexion to 90° in the sagittal plane, arm abduction to 60° in the scapular plane and arm medial rotation to 60°. Movements were performed 3 sets of 10 repetitions for each direction. Once scapular control had improved, external resistance exercises with a light weight or a thera-band were added to the program. Same exercise intensity (3 sets of 10 repetitions for each direction) was used. The duration of the exercise and MTrP therapy within each session was about 1 hour.
2. The socio-demographic data, occupational factors, characteristics of shoulder complaints, shoulder aberrant movements, pressure pain threshold, and shoulder range of motion will be evaluated as potential prognostic factors. All patients will receive motor control exercises combined with MTrP therapy twice a week for 8 weeks or until patients achieve their goals.
Intervention code [1] 297295 0
Diagnosis / Prognosis
Intervention code [2] 298853 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301245 0
Pain intensity assessed by numeric rating scale (NRS).
Timepoint [1] 301245 0
Baseline, upon completion of 8 weeks of intervention, and 6-month followup
Primary outcome [2] 301246 0
Shoulder disability: Patient-Specific Functional Scale
Timepoint [2] 301246 0
Baseline, upon completion of 8 weeks of intervention
Primary outcome [3] 301606 0
Global Rating of Change Score
Timepoint [3] 301606 0
Baseline, upon completion of 8 weeks of intervention, and 6-month followup
Secondary outcome [1] 337536 0
Number of muscles with trigger points assessed by physical examination by a physiotherapist.
Timepoint [1] 337536 0
Baseline, upon completion of 8 weeks of intervention
Secondary outcome [2] 337537 0
Shoulder motor control impairments assessed by physical examination by a physiotherapist.
Timepoint [2] 337537 0
Baseline, upon completion of 8 weeks of intervention
Secondary outcome [3] 337538 0
Shoulder Disability (Quick DASH)
Timepoint [3] 337538 0
Baseline, upon completion of 8 weeks of intervention
Secondary outcome [4] 337539 0
Exercise compliance by calculating the percentage of exercise sessions successfully completed at the clinic.
Timepoint [4] 337539 0
Baseline, upon completion of 8 weeks of intervention

Eligibility
Key inclusion criteria
unilateral shoulder impingement syndrome
Subjects had to demonstrate at least 3 of the following:
(1) Neer impingement test: +
(2) Hawkins impingement test: +
(3) Painful arc
(4) Pain with isometric resisted abduction
(5) Pain with palpation of the rotator cuff tendons
(6) Pain with active shoulder elevation
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral shoulder pain
Affected shoulder dislocation, fracture, adhesive capsulitis, previous surgery
Full-thickness rotator cuff tear
Reproduction of shoulder symptoms with cervical spine examination
History of any systemic or neurologic disease affecting the shoulder

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
(1) Univariate analysis
Responders and non-responders: possible predictors
Independent t tests: continuous variables (p<0.15)
Chi-square tests: categorical variables (p<0.15)

(2) Multivariate stepwise logistic regression analysis
Significant predictors for treatment response (p<0.05)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
110
Final
Recruitment outside Australia
Country [1] 8692 0
Taiwan, Province Of China
State/province [1] 8692 0

Funding & Sponsors
Funding source category [1] 295746 0
Hospital
Name [1] 295746 0
Shin Kong Memorial Wu Ho-Su Hospital
Country [1] 295746 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Shin Kong Memorial Wu Ho-Su Hospital
Address
No. 95, Wen Chang Road, Shih Lin District, Taipei City
Country
Taiwan, Province Of China
Secondary sponsor category [1] 296168 0
None
Name [1] 296168 0
Address [1] 296168 0
Country [1] 296168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297045 0
Shin Kong Memorial Wu Ho-Su Hospital Institutional Review Board (IRB)
Ethics committee address [1] 297045 0
No. 95, Wen Chang Road, Shih Lin District, Taipei City
Ethics committee country [1] 297045 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297045 0
20/03/2016
Approval date [1] 297045 0
16/06/2016
Ethics approval number [1] 297045 0
20160405R

Summary
Brief summary
Background: Subacromial impingement syndrome (SIS) was one of the most common causes of shoulder pain. Theoretically, exercise focus on motor control training combined with myofascial trigger points (MTrP) therapy can result in positive treatment outcome. However, there were still patients did not respond more to this kind of treatment than general therapeutic exercise for their SIS. Purposes: (1) To investigate the predictors for the effects from motor control training combined with MTrP therapy in patients with SIS. (2) To specifically determine the influencing factors of the magnitude of changes in function and pain after receiving motor control training combined with MTrP therapy. Research design: A prospective cohort study design. Methods: We plan to recruit 120 patients of SIS treated with motor control training combined with MTrP therapy for 8 weeks. Their socio-demographic data, occupational factors, characteristics of shoulder complaints, shoulder aberrant movements and fear avoidance belief were recorded. Outcome assessments were performed after intervention. The treatment responders were determined by fulfilling two of the two criteria: (1) increase of function (Patient Specific Functional Scale) > 1.2, (2) decrease of pain (Numeric Pain Rating Scale) > 2.17. Statistical analyses: For study purpose 1: univariate analyses comparing differences between responders and non-responders will be used to identify possible predictors (p<0.15). Then, a multivariate stepwise logistic regression analysis will be used to identify significant predictors for the treatment effect (p<0.05). For study purpose 2: the correlation analyses will be performed to find the possible affecting factor of the changing of the pain and function (p<0.15), then multivariate analysis will be used to identify those factors associated with the improvement of pain and function (p<0.05).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72798 0
A/Prof Tzyy-Jiuan Wang
Address 72798 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei
Country 72798 0
Taiwan, Province Of China
Phone 72798 0
+886-2-2826-7091
Fax 72798 0
+886-2-2820-1841
Email 72798 0
[email protected]
Contact person for public queries
Name 72799 0
Tzyy-Jiuan Wang
Address 72799 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei
Country 72799 0
Taiwan, Province Of China
Phone 72799 0
+886-2-2826-7091
Fax 72799 0
+886-2-2820-1841
Email 72799 0
[email protected]
Contact person for scientific queries
Name 72800 0
Tzyy-Jiuan Wang
Address 72800 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei
Country 72800 0
Taiwan, Province Of China
Phone 72800 0
+886228267091
Fax 72800 0
Email 72800 0
[email protected]

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