Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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10 December 2018 |
Main ID: |
ACTRN12617000044325 |
Date of registration:
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10/01/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Immediate effect of myofascial trigger points therapy in patients with unilateral shoulder impingement syndrome
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Scientific title:
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Effectiveness of myofascial trigger point therapy combined with corticosteroid injection versus myofascial trigger point therapy or corticosteroid injection alone on pain, pressure pain sensitivity, shoulder range of motion, shoulder function, and motor control in patients with unilateral shoulder impingement syndrome |
Date of first enrolment:
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08/08/2016 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12617000044325.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Countries of recruitment
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Taiwan, Province Of China
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Contacts
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Name:
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A/Prof Tzyy-Jiuan Wang
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Address:
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National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Taiwan, Province Of China |
Telephone:
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+886228267091 |
Email:
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tjwang@ym.edu.tw |
Affiliation:
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Name:
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A/Prof Tzyy-Jiuan Wang
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Address:
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National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Taiwan, Province Of China |
Telephone:
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+886228267091 |
Email:
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tjwang@ym.edu.tw |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 20-65 patients with chronic unilateral nontraumatic shoulder pain
2. Meet at least 1 following 3 clinical diagnostic test: Neer tests (pain during passive abduction) / Hawkins test / painful arc sign
3. Numerical pain rating scale (NRS): >3/10 points during shoulder movement
4. Diagnosis of SIS by physiatrists
Exclusion criteria: 1. History of shoulder fractures or dislocation
2. Cervical radiculopathy
3. Previous interventions with steroid injections in past three months
4. Previous history of shoulder surgery
5. Systemic diseases (rheumatoid arthritis, Reiter’s syndrome, diabetes
6. Neurological diseases or other severe medical or psychiatric disorders
7. Frozen shoulder
8. Full-thickness rotator cuff tear
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Musculoskeletal - Other muscular and skeletal disorders
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Patients with unilateral shoulder impingement syndrome; Patients with unilateral shoulder impingement syndrome
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Intervention(s)
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1. The trigger point therapy group will receive one session of myofascial trigger point therapy by an experienced physiotherapist. Treatment process will be repeated 3 times on each active/latent trigger point in seven following muscles: upper trapezius, levator scapulae, rhomboids, pectoralis minors, supraspinatus, infraspinatus, teres minors. Pressure on each trigger point will be maintained for 30-60 seconds (<1 minute), The whole treatment lasts between 20 and 30 minutes. These procedures are performed only once. 2. The ultrasonographic (US)-guided subacromial injection group will receive corticosteroid injection into the subacromial bursa (Triamcinolone 1 ml of 10mg/1mL with 1% lidocaine is injected) by a physiatrist. This injection is performed only once. 3. The combined treatment group will receive myofascial trigger point therapy and corticosteroid injection (Triamcinolone 1 ml of 10mg/1mL with 1% lidocaine) into the subacromial bursa. The injection administered immediately before myofascial trigger point therapy. These procedures/injection are performed only once. 4. Since only one treatment is administered, fidelity issue is not applicable.
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Primary Outcome(s)
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Pressure pain threshold assessed by digital algometer
[Baseline, immediately after one session intervention, and at 7 days after intervention]
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Pain intensity assessed by numeric rating scale (NRS).
[Baseline, immediately after one session intervention, and at 7 days after intervention]
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Shoulder motor control ability by kinetic shoulder motor control test
[Baseline, immediately after one session intervention, and at 7 days after intervention]
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Secondary Outcome(s)
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Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
[Baseline and at 7 days after intervention
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Functional activity assessed by patient specific-functional scale (PSFS)
[Baseline and at 7 days after intervention]
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Global rating of change scale
[Immediately after one session intervention, and at 7 days after intervention
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Shoulder range of motion assessed by goniometer and inclinometer
[Baseline, immediately after one session intervention, and at 7 days after intervention
]
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Source(s) of Monetary Support
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Shin Kong Wu Ho-Su Memorial Hospital
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National Yang-Ming University
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Ethics review
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Status: Approved
Approval date:
Contact:
Shin Kong Wu Ho-Su Memorial Hospital Institutional Review Board (IRB)
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Results
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Results available:
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Yes |
Date Posted:
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03/12/2018 |
Date Completed:
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16/06/2017 |
URL:
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