Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001114538
Ethics application status
Approved
Date submitted
29/09/2015
Date registered
22/10/2015
Date last updated
27/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the Relevance of Acupuncture Channel Theory in the Treatment of Myofascial Pain in the Upper Trapezius Muscle: A Randomised Controlled Trial
Scientific title
Testing the treatment of patients with pain in the upper trapezius muscle using various forms of acupuncture therapy vs sham.
Secondary ID [1] 287239 0
None
Universal Trial Number (UTN)
U1111-1172-9914
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myofascial pain affecting the upper trapezius muscle 295846 0
Condition category
Condition code
Musculoskeletal 296101 296101 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 4 intervention arms including the sham control arm.
Group 1 (local point group) will receive needling to the primary local point/myofascial trigger point in the upper trapezius only. This group will receive a maximum of 2 needles dependant on whether their symptoms are unilateral or bilateral.
Group 2 (combination treatment group) will receive the same treatment as Group 1 with the addition of two distal points needled bilaterally (additional 4 needles). The most relevant points will be selected from the following pairings as determined by Chinese Medicine channel theory; SI3 & BL60, LI4 & ST37 or TE5 & GB34. This group will receive 5-6 needles dependant on whether their symptoms are unilateral or bilateral.
Group 3 (distal points only group) will receive the same treatment as Group 2 with the omission of the local points in the upper trapezius muscle. This group will receive a total of 4 needles.
All needling/intervention groups will receive treatment from an experienced registered acupuncturist, which will involve insertion of the needles and retention for 20 minutes followed by removal and disposal of the needles. Standardised rotational manipulation will be applied to each needle upon insertion, at 5 minutes, at 10 minutes and at 15 minutes.
All treatment interventions will be performed on-site at the UTS TCM Outpatient Clinic.
Intervention code [1] 292531 0
Treatment: Other
Comparator / control treatment
The control group will be receiving the same treatment as Group 2 (combination treatment), however this treatment will be performed using a deactivated (diode removed) therapeutic laser device. This device will still emit sound and screen displays are still active, giving the impression that the device is performing as it is intended.
The credibility of this treatment will be measured using a Credibility Expectancy Questionnaire (CEQ).
Control group
Placebo

Outcomes
Primary outcome [1] 295777 0
Pressure pain threshold using a digital algometer.
Timepoint [1] 295777 0
2 weeks post treatment cycle (4 treatments in 2 weeks).
Primary outcome [2] 295826 0
Visual analogue scale for pain
Timepoint [2] 295826 0
2 weeks post treatment cycle
Primary outcome [3] 295827 0
Patient quality of life assessed by SF-36
Timepoint [3] 295827 0
2 weeks post treatment cycle
Secondary outcome [1] 316597 0
Goniometry - range of motion in lateral neck flexion
Timepoint [1] 316597 0
2 weeks post treatment cycle
Secondary outcome [2] 316598 0
Upper extremity functional index
Timepoint [2] 316598 0
2 weeks post treatment cycle
Secondary outcome [3] 316599 0
Neck disability index
Timepoint [3] 316599 0
2 weeks post treatment cycle
Secondary outcome [4] 316602 0
MGH Acupuncture Sensation Scale
Timepoint [4] 316602 0
After each treatment session

Eligibility
Key inclusion criteria
Self-selecting individuals assessed against a common criteria as experiencing myofascial pain in the upper trapezius muscle.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fibromyalgia
Cervical disorder with radiculopathy
Osteoarthritis
Inability to consent
Complex systemic disease
Pregancy
Contraindications to acupuncture therapy

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)
Subjects will self-select for inclusion and be assessed against the inclusion criteria.
If they qualify they will be randomised into 1 of 4 groups through a computer generated randomised schedule based on order of contact.
The group allocation is revealed, by contacting the holder of the allocation schedule located off-site to the study, only to the treating practitioner who is blinded to the results of the outcome measures.
The outcome assessor is kept blind to the participants group allocation throughout the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list from a randomisation software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
4 parallel arms
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The size of 60 (20 per group) has been calculated as the appropriate number to obtain a statistically significant outcome based on the effect size noted in similar studies.
For within group analysis (pre vs post vs control) t tests will be used. In these circumstances, given:
* an effect size of 0.67.
* alpha of 0.05
* power value of 0.8,
*standard deviation of 0.71
*a valid group size would be n=19.
Based on these calculations 80 participants will be recruited, 20 per group, to account for potential dropouts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/11/2014
Date of last participant enrolment
Anticipated
1/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291830 0
University
Name [1] 291830 0
University of Technology Sydney
Country [1] 291830 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 290491 0
None
Name [1] 290491 0
Address [1] 290491 0
Country [1] 290491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293346 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 293346 0
15 Broadway
Ultimo NSW 2007
Ethics committee country [1] 293346 0
Australia
Date submitted for ethics approval [1] 293346 0
Approval date [1] 293346 0
08/09/2014
Ethics approval number [1] 293346 0
HREC 2011000467)

Summary
Brief summary
The design of this study is a prospective single-blind parallel four arm randomised placebo controlled trial with repeated measures. The purpose of this study is to investigate various methods of acupuncture therapy in the treatment of myofascial pain in the upper trapezius muscle.

This study is designed to test the following hypotheses; 1) There is no significant difference between needling locally and needling relevant distal points only in the treatment of myofascial pain; and 2) Needling a combination of both local and distal points is superior to needling either local points or relevant distal points alone in the treatment of myofascial pain; 3) Acupuncture is superior to placebo in the treatment of myofascial pain.

Participants will be randomly allocated to one of four groups that will receive one of three types of acupuncture therapy, with the remaining group acting as a control group.
Trial website
N/A
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 59382 0
A/Prof Peter Charles Meier
Address 59382 0
Building 7 Level 7 Room 26
University of Technology Sydney
15 Broadway
Ultimo NSW 2007
Country 59382 0
Australia
Phone 59382 0
+61 2 9514 7858
Fax 59382 0
Email 59382 0
Peter.Meier@uts.edu.au
Contact person for public queries
Name 59383 0
Dale Scott Elsdon
Address 59383 0
Building 7 Level 7 Room 26
University of Technology Sydney
15 Broadway
Ultimo NSW 2007
Country 59383 0
Australia
Phone 59383 0
+614 2248 3106
Fax 59383 0
Email 59383 0
Dale.Elsdon@uts.edu.au
Contact person for scientific queries
Name 59384 0
Peter Charles Meier
Address 59384 0
Building 7 Level 7 Room 26
University of Technology Sydney
15 Broadway
Ultimo NSW 2007
Country 59384 0
Australia
Phone 59384 0
+61 2 9514 7858
Fax 59384 0
Email 59384 0
Peter.Meier@uts.edu.au

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
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