Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000901404
Ethics application status
Approved
Date submitted
14/05/2016
Date registered
7/07/2016
Date last updated
7/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of myofascial trigger point therapy in patients with chronic neck and/or arm pain
Scientific title
Effectiveness of myofascial trigger point therapy versus sham myofascial trigger point therapy on pain intensity, feeling of tightness, pain sensitivity, pain-free cervical range of motion, function, and disability in patients with chronic neck and/or arm pain
Secondary ID [1] 288915 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with chronic neck and/or arm pain 298247 0
Condition category
Condition code
Musculoskeletal 298391 298391 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 299394 299394 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive one session of myofascial trigger point therapy by an experienced physiotherapist. The physiotherapy will apply slow pressure to the myofascial trigger point to a moderate pain. Pressure on each trigger point will be maintained for 30-60 seconds (<1 minute), Treatment process will be repeated 3 times on each active/latent trigger point in five following muscles: upper trapezius, levator scapulae, sternocleidomastoid, scalene, and splenius cervicis. The whole treatment lasts between 15 and 20 minutes.
Intervention code [1] 294376 0
Treatment: Other
Intervention code [2] 294377 0
Rehabilitation
Comparator / control treatment
The control group will receive a sham myofascial trigger point therapy (apply very lightly pressure or rub out the trigger points in neck muscles for 15~20 minutes,
Control group
Placebo

Outcomes
Primary outcome [1] 297868 0
Pain intensity assessed by numeric rating scale (NRS).
Timepoint [1] 297868 0
Baseline, immediately after one session intervention, and at 2 days after intervention
Primary outcome [2] 297869 0
Primary Outcome 2: Cervical active/pain-free range of motion assessed by cervical-range-of-motion measurement device
Timepoint [2] 297869 0
Baseline, immediately after one session intervention, and at 2 days after intervention
Secondary outcome [1] 322487 0
Pressure pain threshold assessed by digital algometer
Timepoint [1] 322487 0
Baseline, immediately after one session intervention, and at 2 days after intervention
Secondary outcome [2] 322488 0
Tight feeling assessed by 10-point likert scale
Timepoint [2] 322488 0
Baseline, immediately after one session intervention, and at 2 days after intervention
Secondary outcome [3] 322489 0
Functional activity assessed by patient specific-functional scale (PSFS)
Timepoint [3] 322489 0
Baseline, immediately after one session intervention, and at 2 days after intervention
Secondary outcome [4] 322490 0
Disability assessed by neck disability index (NDI)
Timepoint [4] 322490 0
Baseline, immediately after one session intervention, and at 2 days after intervention

Eligibility
Key inclusion criteria
1. Aged 20-65 patients with chronic neck and/or arm pain
2. Pain intensity (numeric rating scale)>3
3. Presence of active trigger point in at least one of the five following muscles: upper trapezius, levator scapulae, sternocleidomastoid, scalene, splenius cervicis
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neck surgery during the previous 12 months
2. Pregnancy
3. Administration of anti-inflammatory analgesics over the preceding 24 hours

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subject will be randomized into either the control or the intervention group by drawing lots
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2015
Date of last participant enrolment
Anticipated
Actual
6/05/2016
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7765 0
Taiwan, Province Of China
State/province [1] 7765 0
Taipei

Funding & Sponsors
Funding source category [1] 293263 0
University
Name [1] 293263 0
National Yang-Ming University
Country [1] 293263 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] 292066 0
None
Name [1] 292066 0
Address [1] 292066 0
Country [1] 292066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294744 0
Chen-Hsin General Hospital Institutional Review Board (IRB)
Ethics committee address [1] 294744 0
Ethics committee country [1] 294744 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294744 0
19/05/2015
Approval date [1] 294744 0
07/07/2015
Ethics approval number [1] 294744 0
(484)104-20

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

Contacts
Principal investigator
Name 64894 0
A/Prof Tzyy-Jiuan Wang
Address 64894 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan. National Yang-Ming University
Country 64894 0
Taiwan, Province Of China
Phone 64894 0
+886-2-2826-7091
Fax 64894 0
Email 64894 0
[email protected]
Contact person for public queries
Name 64895 0
Tzyy-Jiuan Wang
Address 64895 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan. National Yang-Ming University
Country 64895 0
Taiwan, Province Of China
Phone 64895 0
+886-2-2826-7091
Fax 64895 0
Email 64895 0
[email protected]
Contact person for scientific queries
Name 64896 0
Tzyy-Jiuan Wang
Address 64896 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan. National Yang-Ming University
Country 64896 0
Taiwan, Province Of China
Phone 64896 0
+886-2-2826-7091
Fax 64896 0
+886-2-2820-1841
Email 64896 0
[email protected]

No information has been provided regarding IPD availability


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.