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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: ANZCTR
Last refreshed on: 10 December 2018
Main ID:  ACTRN12617000044325
Date of registration: 10/01/2017
Prospective Registration: No
Primary sponsor: National Yang-Ming University
Public title: Immediate effect of myofascial trigger points therapy in patients with unilateral shoulder impingement syndrome
Scientific title: 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: 08/08/2016
Target sample size: 60
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12617000044325.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial;  
Phase: 
Countries of recruitment
Taiwan, Province Of China
Contacts
Name: A/Prof Tzyy-Jiuan Wang   
Address:  National Yang-Ming University No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei Taiwan, Province Of China
Telephone: +886228267091
Email: tjwang@ym.edu.tw
Affiliation: 
Name: A/Prof Tzyy-Jiuan Wang   
Address:  National Yang-Ming University No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei Taiwan, Province Of China
Telephone: +886228267091
Email: tjwang@ym.edu.tw
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Musculoskeletal - Other muscular and skeletal disorders
Patients with unilateral shoulder impingement syndrome;
Patients with unilateral shoulder impingement syndrome
Intervention(s)
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.
Primary Outcome(s)
Pressure pain threshold assessed by digital algometer

[Baseline, immediately after one session intervention, and at 7 days after intervention]
Pain intensity assessed by numeric rating scale (NRS).

[Baseline, immediately after one session intervention, and at 7 days after intervention]
Shoulder motor control ability by kinetic shoulder motor control test



[Baseline, immediately after one session intervention, and at 7 days after intervention]
Secondary Outcome(s)
Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
[Baseline and at 7 days after intervention
]
Functional activity assessed by patient specific-functional scale (PSFS)

[Baseline and at 7 days after intervention]
Global rating of change scale
[Immediately after one session intervention, and at 7 days after intervention
]
Shoulder range of motion assessed by goniometer and inclinometer
[Baseline, immediately after one session intervention, and at 7 days after intervention
]
Secondary ID(s)
None
Source(s) of Monetary Support
Shin Kong Wu Ho-Su Memorial Hospital
National Yang-Ming University
Secondary Sponsor(s)
Shin Kong Wu Ho-Su Memorial Hospital
Ethics review
Status: Approved
Approval date:
Contact:
Shin Kong Wu Ho-Su Memorial Hospital Institutional Review Board (IRB)
Results
Results available: Yes
Date Posted: 03/12/2018
Date Completed: 16/06/2017
URL:
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