Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000044325
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
10/01/2017
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 290708 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with unilateral shoulder impingement syndrome 301268 0
Condition category
Condition code
Musculoskeletal 301025 301025 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296599 0
Rehabilitation
Intervention code [2] 296600 0
Treatment: Other
Intervention code [3] 296689 0
Treatment: Drugs
Comparator / control treatment
The ultrasonographic (US)-guided subacromial injection group will receive corticosteroid injection (Triamcinolone 1 ml of 10mg/1mL with 1% lidocaine is injected) by a physiatrist. Comparisons will be made between all of the three listed treatment arms.
Control group
Active

Outcomes
Primary outcome [1] 300444 0
Pain intensity assessed by numeric rating scale (NRS).
Timepoint [1] 300444 0
Baseline, immediately after one session intervention, and at 7 days after intervention
Primary outcome [2] 300445 0
Pressure pain threshold assessed by digital algometer
Timepoint [2] 300445 0
Baseline, immediately after one session intervention, and at 7 days after intervention
Primary outcome [3] 300446 0
Shoulder motor control ability by kinetic shoulder motor control test
Timepoint [3] 300446 0
Baseline, immediately after one session intervention, and at 7 days after intervention
Secondary outcome [1] 330001 0
Shoulder range of motion assessed by goniometer and inclinometer
Timepoint [1] 330001 0
Baseline, immediately after one session intervention, and at 7 days after intervention
Secondary outcome [2] 330002 0
Functional activity assessed by patient specific-functional scale (PSFS)
Timepoint [2] 330002 0
Baseline and at 7 days after intervention
Secondary outcome [3] 330003 0
Disabilities of Arm, Shoulder and Hand (DASH) questionnaire
Timepoint [3] 330003 0
Baseline and at 7 days after intervention
Secondary outcome [4] 330004 0
Global rating of change scale
Timepoint [4] 330004 0
Immediately after one session intervention, and at 7 days after intervention

Eligibility
Key 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
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
8/08/2016
Date of last participant enrolment
Anticipated
Actual
1/05/2017
Date of last data collection
Anticipated
Actual
16/06/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8467 0
Taiwan, Province Of China
State/province [1] 8467 0

Funding & Sponsors
Funding source category [1] 295135 0
University
Name [1] 295135 0
National Yang-Ming University
Country [1] 295135 0
Taiwan, Province Of China
Funding source category [2] 295136 0
Hospital
Name [2] 295136 0
Shin Kong Wu Ho-Su Memorial Hospital
Country [2] 295136 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 293957 0
Hospital
Name [1] 293957 0
Shin Kong Wu Ho-Su Memorial Hospital
Address [1] 293957 0
No. 95, Wen Chang Road, Shih Lin District, Taipei, 11221, Taiwan
Country [1] 293957 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296484 0
Shin Kong Wu Ho-Su Memorial Hospital Institutional Review Board (IRB)
Ethics committee address [1] 296484 0
No. 95, Wen Chang Road, Shih Lin District, 111, Taipei
Ethics committee country [1] 296484 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296484 0
05/04/2016
Approval date [1] 296484 0
16/06/2016
Ethics approval number [1] 296484 0
20160405R

Summary
Brief summary
To investigate whether myofascial trigger point therapy combined with corticosteroid injection is more effective than myofascial trigger point therapy or corticosteroid injection alone on pain, pressure pain sensitivity, shoulder range of motion, shoulder function, and shoulder motor control ability in patients with SIS
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71026 0
A/Prof Tzyy-Jiuan Wang
Address 71026 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71026 0
Taiwan, Province Of China
Phone 71026 0
+886228267091
Fax 71026 0
+886228201841
Email 71026 0
tjwang@ym.edu.tw
Contact person for public queries
Name 71027 0
A/Prof Tzyy-Jiuan Wang
Address 71027 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71027 0
Taiwan, Province Of China
Phone 71027 0
+886228267091
Fax 71027 0
+886228201841
Email 71027 0
tjwang@ym.edu.tw
Contact person for scientific queries
Name 71028 0
A/Prof Tzyy-Jiuan Wang
Address 71028 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71028 0
Taiwan, Province Of China
Phone 71028 0
+886228267091
Fax 71028 0
+886228201841
Email 71028 0
tjwang@ym.edu.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
privacy concern


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
No additional documents have been identified.