Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001169639
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
6/11/2014
Date last updated
19/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of skin resistivity for upper trapezius trigger points in healthy humans
Scientific title
For subjects with lateral latent trigger points (TrPs) as compared to TrPs-negative side within the upper trapezius, does skin resistivity measurement allow to distinguish TrPs from non-TrPs and, thus, objectively support Travel and Simon’s diagnostic criteria.
Secondary ID [1] 285496 0
None
Universal Trial Number (UTN)
U1111-1162-8176
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofascial pain 293285 0
Condition category
Condition code
Musculoskeletal 293553 293553 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293554 293554 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty two healthy volunteers with unilateral latent TrPs within the upper trapezius muscle will be recruited to the study. Each of the participants will be re-diagnosed towards unilateral TrPs confirmation within the upper trapezius muscle. Additionally, the presence of confirmatory signs, namely referred pain and twitch response, will be examined. Then, the localization of TrPs defined by Travell and Simons as x1 and x2 will be marked and the same will be done for the area corresponding to the region common for TrPs (control). Then, the examiner will look for 4 pain-free points on each side (not tender; without any features of TrPs) in the closest area to the previously marked crosses. When the four points will be found, they will be marked and named norm. Next, the skin resistance measurement will be performed.
The participants will be evaluated towards skin resistance in the marked area by an expert without any knowledge about TrPs examination results. During tests, a Keithley electrometer 610B will be used for measuring skin resistance (Ag/AgCl self-adhesive, disposable ground electrode; 30 mm diameter). The electrodes will be placed on the specific points of the skin. Two electrodes will be put on the points defined as x1 and x2 within the upper trapezius (TrPs-positive and control), four – on other points which will show no evidence of pathology (norm). One of the norm points (positioned centrally in relation to the other) will function as a reference point. Skin resistance (in ohms) will be measured once in every marked point. The electrometer will be rezeroed before every measurement. Input parameters will be turned off, and the electrometer will be corrected for internal noise to recalibrate as the participants change. All test will be completed in a climate controlled room. The duration of the procedure for each participant will be around 30 minutes and it will be conducted on a single occasion only.
Data analysis
Previously obtained resistance values from each of the marked points (TrPs-positive, control and norm) will be used to calculate the resistivity using the formula:
resistivity =RS/x ;
resistivity [Ohm*m]; R – resistance [Ohm]; S – electrode surface [m2]; x – distance between electrodes (reference and others) [m].
The mean value obtained from the calculations made for three norm points will be determined in order to calculate the so-called personal norm for the pain-free area (without any TrPs features).
Additionally, TrPs skin resistivity value will be analyzed as regards the gender and the presence of confirmatory signs (referred pain and twitch response).
Intervention code [1] 290435 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator: the control will be the non-TrPs side of the upper trapezius of the same participants.
Control group
Active

Outcomes
Primary outcome [1] 293369 0
The difference in the skin resistivity value between TrPs to non-TrPs

Decrease or increase of the skin resistivity will be analysed
During tests, a Keithley electrometer 610B will be used for measuring skin resistance (Ag/AgCl self-adhesive, disposable ground electrode; 30 mm diameter).
Timepoint [1] 293369 0
Just after TrPs confirmation
Secondary outcome [1] 310877 0
The difference in the skin resistivity value between TrPs to non-TrPs regarding the gender.

Decrease or increase of the skin resistivity will be analysed.

During tests, a Keithley electrometer 610B will be used for measuring skin resistance (Ag/AgCl self-adhesive, disposable ground electrode; 30 mm diameter).
Timepoint [1] 310877 0
Just after TrPs confirmation
Secondary outcome [2] 311066 0
The difference in the skin resistivity value of TrPs regarding twitch response and referred pain presence

During tests, a Keithley electrometer 610B will be used for measuring skin resistance (Ag/AgCl self-adhesive, disposable ground electrode; 30 mm diameter).
Timepoint [2] 311066 0
Just after TrPs confirmation

Eligibility
Key inclusion criteria
The inclusion criteria will be unilateral latent trigger points within the upper trapezius muscle.
Minimum age
20 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria will be: (i) rheumatologic or neurological diseases and other serious medical conditions, real pain problems of the shoulder girdle and neck (because of the measurement methods of electrodermal skin resistance); (ii) surgery or/and post-traumatic incidence of the upper extremity and neck; (iii) diabetic problems; (iv) current use of some pain killers and other pharmacotherapies; (v) dermal problems of the upper back skin.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited to the study from the students group of the Poznan University of Medical Sciences.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to William Cochran’s assumption for x2 test, to conduct the test the quantity of n=5 is required. It is assumed that in the examined group the following types of points will be present:
TrPs within the upper trapezius muscle without confirmatory signs
TrPs within the upper trapezius with referred pain
TrPs within the upper trapezius with twitch response
non-TrPs
Additionally, the data will be analyzed based on the gender. As a result, the information about the minimal size of the sample will be obtained (4 features* 2 gender categories* the quantity of n=5 per subgroup; n=40).
For the strong evidence of data presented, the significance level will be set based on exact tests, not on the default asymptotic method. Exact t-tests will be performed in order to ensure that data are representative of the whole population of possible data values. Tests will be applied to compare the differences in skin resistivity values for TrPs as compared to non-TrPs area corresponding to the common region of TrPs presence and to non-TrPs in the nearest vicinity of TrPs.
All of the above dependencies as regards gender division will be tested by an exact t-test.
The difference in skin resistivity of TrPs-positive regarding referred pain and twitch response occurrence will be tested by an exact t-test.
Values in the text, figures and tables are expressed as mean + standard mean error (SEs). All levels of probability were set at a significance level of 0.05. The statistical analysis was performed using IBM SPSS Statistics, version 20.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2012
Actual
17/11/2012
Date of last participant enrolment
Anticipated
28/11/2014
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 6422 0
Poland
State/province [1] 6422 0

Funding & Sponsors
Funding source category [1] 290096 0
University
Name [1] 290096 0
Poznan University of Medical Sciences
Country [1] 290096 0
Poland
Primary sponsor type
University
Name
Poznan University of Medical Sciences
Address
Fredry street no 10
61-701 Poznan
Country
Poland
Secondary sponsor category [1] 288802 0
None
Name [1] 288802 0
Address [1] 288802 0
Country [1] 288802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291804 0
Ethics Committee
Ethics committee address [1] 291804 0
Ethics committee country [1] 291804 0
Poland
Date submitted for ethics approval [1] 291804 0
03/10/2012
Approval date [1] 291804 0
24/10/2012
Ethics approval number [1] 291804 0
790/12

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

Contacts
Principal investigator
Name 52090 0
Dr Elzbieta Skorupska
Address 52090 0
Poznan University of Medical Sciences
Fredry street no 10
61-701 Poznan
Country 52090 0
Poland
Phone 52090 0
+48 694 398 333
Fax 52090 0
Email 52090 0
[email protected]
Contact person for public queries
Name 52091 0
Elzbieta Skorupska
Address 52091 0
Poznan University of Medical Sciences
Fredry street no 10
61-701 Poznan
Country 52091 0
Poland
Phone 52091 0
+48 694 398 333
Fax 52091 0
Email 52091 0
[email protected]
Contact person for scientific queries
Name 52092 0
Elzbieta Skorupska
Address 52092 0
Poznan University of Medical Sciences
Fredry street no 10
61-701 Poznan
Country 52092 0
Poland
Phone 52092 0
+48 694398333
Fax 52092 0
Email 52092 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
SourceTitleYear of PublicationDOI
Dimensions AISkin Resistivity Value of Upper Trapezius Latent Trigger Points2015https://doi.org/10.1155/2015/351726
N.B. These documents automatically identified may not have been verified by the study sponsor.