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Trial registered on ANZCTR


Registration number
ACTRN12619001275156
Ethics application status
Approved
Date submitted
8/07/2019
Date registered
16/09/2019
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of the effects of myofascial trigger point therapy with neck-specific exercises and general exercises in office workers with non-specific neck pain
Scientific title
The comparison of the effects of myofascial trigger point therapy with neck-specific exercises and general exercises on pain intensity, cervical range of motion, function and disability in office workers with non-specific neck pain
Secondary ID [1] 298408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific neck pain 313113 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311592 311592 0 0
Physiotherapy
Musculoskeletal 311593 311593 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive myofascial trigger point therapy by a physical therapist once a week for 4 weeks. The physical therapist will apply moderate compression on subjects' three most uncomfortable trigger points (according to trigger point assessment) for 60 seconds. Then subjects will perform the neck-specific exercises including stretching exercises for levator scapulae, anterior scalene, infraspinatus, pectoralis minor, sternocleidomastoid and neck extensors as well as strengthening exercise of the upper trapezius. The total treatment time will be 30 minutes per session. Subjects will be informed to do a 15-minute home program including ball massage and exercises (same as the intervention exposure) three times a week for 4 weeks. The therapist will monitor adherence to the intervention by participant diary and mobile phone message reminders (twice a week).
Intervention code [1] 314653 0
Treatment: Other
Intervention code [2] 314654 0
Rehabilitation
Comparator / control treatment
The control group will receive myofascial trigger point therapy and a general lower limb exercise (quadratus lumborum stretches, squats, marching in place) by a physical therapist. The total treatment time will be 15-20 minutes. Subjects will be informed to do a home program including ball massage and exercises three times a week for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 320304 0
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS)
Timepoint [1] 320304 0
1. Immediately after the first treatment session
2. Immediately after the last treatment session [Primary timepoint]
3. At the follow-up (4 weeks after the last intervention)
Primary outcome [2] 320305 0
Function and disability by Neck Pain and Disability Scale (NPDS)
Timepoint [2] 320305 0
1. Immediately after the first treatment session
2. Immediately after the last treatment session [Primary timepoint]
3. At the follow-up (4 weeks after the last intervention)
Primary outcome [3] 320306 0
Function measure by the Patient-Specific Functional Scale
Timepoint [3] 320306 0
1. Immediately after the first treatment session
2. Immediately after the last treatment session [Primary timepoint]
3. At the follow-up (4 weeks after the last intervention)
Secondary outcome [1] 371136 0
Primary outcome [4]: Perceived effect by Global Rating of Change Scale (GROC)
Timepoint [1] 371136 0
1. Immediately after the first treatment session
2. Immediately after the last treatment session [Primary timepoint]
3. At the follow-up (4 weeks after the last intervention)
Secondary outcome [2] 371137 0
Cervical range of motion by the Cervical Range of Motion device
Timepoint [2] 371137 0
1. Immediately after the first treatment session
2. Immediately after the last treatment session

Secondary outcome [3] 373303 0
Pressure Pain Threshold measured by an algometer
Timepoint [3] 373303 0
Immediately after the last treatment session

Eligibility
Key inclusion criteria
1. 20-65 years old.
2. Symptoms frequency of at least once a week.
3. Use a computer at least 30 hours per week.
4. Pain intensity (NPRS) >= 2/10.
5. Existence of at least one trigger point in 7 target muscles (occipital muscles, sternocleidomastoid muscle, anterior scalene, upper trapezius, levator scapulae, infraspinatus, pectoralis minor)
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has any neurologic problem
2. Has any systemic disease
3. Pregnancy
4. History of whiplash injury
5. History of any cervical surgery
6. Has cervical radiculopathy or myelopathy
7. Diagnosis of fibromyalgia

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2019
Actual
Date of last participant enrolment
Anticipated
25/06/2020
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21572 0
Taiwan, Province Of China
State/province [1] 21572 0
Taipei

Funding & Sponsors
Funding source category [1] 302949 0
University
Name [1] 302949 0
National Yang-Ming University
Country [1] 302949 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No. 155 Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 302912 0
None
Name [1] 302912 0
Address [1] 302912 0
Country [1] 302912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303511 0
National Yang-Ming University Office of Research and Development Institutional Review Board (IRB)
Ethics committee address [1] 303511 0
Ethics committee country [1] 303511 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 303511 0
28/03/2019
Approval date [1] 303511 0
31/05/2019
Ethics approval number [1] 303511 0
YM108049F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93914 0
A/Prof Tzyy-Jiuan Wang
Address 93914 0
No.155, Sec.2, Li-Nong Street, Beitou, District, Taipei, 11221, Taiwan, National Yang-Ming University
Country 93914 0
Taiwan, Province Of China
Phone 93914 0
+886228267091
Fax 93914 0
Email 93914 0
tjwang@ym.edu.tw
Contact person for public queries
Name 93915 0
Tzyy-Jiuan Wang
Address 93915 0
No.155, Sec.2, Li-Nong Street, Beitou, District, Taipei, 11221, Taiwan, National Yang-Ming University
Country 93915 0
Taiwan, Province Of China
Phone 93915 0
+886228267091
Fax 93915 0
Email 93915 0
tjwang@ym.edu.tw
Contact person for scientific queries
Name 93916 0
Tzyy-Jiuan Wang
Address 93916 0
No.155, Sec.2, Li-Nong Street, Beitou, District, Taipei, 11221, Taiwan, National Yang-Ming University
Country 93916 0
Taiwan, Province Of China
Phone 93916 0
+886228267091
Fax 93916 0
Email 93916 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo For office workers with mild or subclinical neck p... [More Details]

Documents added automatically
No additional documents have been identified.