Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000250932
Ethics application status
Approved
Date submitted
8/09/2019
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Date results information initially provided
26/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
“Effects of bilateral Kinesio Taping on Sternocleidomastoid muscle in chronic neck pain patients: a preliminary study”
Scientific title
“Effects of bilateral Kinesio Taping on Sternocleidomastoid muscle in chronic neck pain patients: a preliminary study”
Secondary ID [1] 291027 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain 314331 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313362 313362 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was carried out in the principal investigator's clinic in Madrid. The intervention was performed by a physiotherapist specializing in kinesiotaping.
The experimental group A received a bilateral kinesiotaping (KT) on sternocleidomastoid muscle (SCM) with muscle stretching. The bandage was maintained for three days from its application in the group. Dependent variables were measured immediately and at 72 and 96 hours from KT application.

The described technique is performed for each group. Cure Tape (Cure Tape, Korea) taping, beige colour, were used. According to Kenzo Kase1 this colour looks like the skin as the taping is not treated with powerful inks. In the EGA, the KT technique on the SCM was applied, according to Kenzo Kase, in contralateral latero-flexion,homolateral rotation and neck extension. In the EGB, the KT technique was performed in a neutral position of the cervical spine. In both cases a Y taping was used, with 2.5cm width, from the mastoids to the sternum-clavicular insertion of the SCM

Intervention code [1] 315512 0
Treatment: Other
Comparator / control treatment
The experimental group B received a bilateral KT application on sternocleidomastoid muscle but without muscle stretching.The bandage was maintained for three days from its application in the group. Dependent variables were measured immediately and at 72 and 96 hours from KT application.
.In the EGB, the KT technique was performed in a neutral position of the cervical spine. In both cases a Y taping was used, with 2.5cm width, from the mastoids to the sternum-clavicular insertion of the SCM
Control group
Active

Outcomes
Primary outcome [1] 321325 0
Pressure pain threshold .
An algometer (Baseline Dolorimeter, Baseline, USA) was used to evaluate the pressure pain threshold in the cranial trigger point of the sternocleidomastoid muscle (SCM) bilaterally.
Timepoint [1] 321325 0
The primary timepoints is baseline, the primary outcome timepoint immediately after its application and 72 hours after its application and 24 hours after its removal,
Primary outcome [2] 321327 0
Pain intensity.
To evaluate the pain intensity at rest and motion, we used the Visual Analogue Scale (VAS). To do this, the patients are showed a horizontal line of 100mm length, with numbers from 0 to 10, indicating the patients that 0 means lack of pain and 10 means unbearable pain.
Timepoint [2] 321327 0
The primary timepoints is baseline, the primary outcome timepoint immediately after its application and 72 hours after its application and 24 hours after its removal,
Primary outcome [3] 321843 0
Craniovertebral angle (CVA)
To evaluate the position of the head, a picture was taken in the sagittal plane, with an Olympus camera (E-420, Olympus, Hamburg, Germany) with a 14-42mm lens, mounted on a tripod and situated at a mark on the ground at 1.5m from the subject. The height of the camera allowed us to focus the patient’s head and trunk, as well as the marks situated on a plumb and a metrical reference (50cm) that was situated in the same plane as the patient. The tragus of the ear and the apophysis of the seventh cervical vertebra (C7) were marked with a dermatologic pen.
Once the picture was taken, it was used to measure the CVA with the PAS software (Postural Analysis Software)
Timepoint [3] 321843 0
he primary timepoints is baseline, the primary outcome timepoint immediately after its application and 72 hours after its application and 24 hours after its removal,
Secondary outcome [1] 374680 0
Range of motion of the cervical spine. Flexion/extension
To perform the measurement of the ranges of motion of the cervical spine, a measurement protocol with a CROM (CROM de Luxe, Performance Attainment Associates, Minnesota, USA) was used. It consists of 2 gravity inclinometers to measure cervical mobility in flexion, extension, this one using a magnetic inclinometer.
Timepoint [1] 374680 0
72 hours after its application and 24 hours after its removal,
Secondary outcome [2] 376435 0
Range of motion of the cervical spine. Lateroflexion
To perform the measurement of the ranges of motion of the cervical spine, a measurement protocol with a CROM (CROM de Luxe, Performance Attainment Associates, Minnesota, USA) was used. It consists of 2 gravity inclinometers to measure cervical mobility in latero-flexion (sagittal and frontal planes) , this one using a magnetic inclinometer.
Timepoint [2] 376435 0
72 hours after its application and 24 hours after its removal,
Secondary outcome [3] 376436 0
Range of motion of the cervical spine. Rotations.
To perform the measurement of the ranges of motion of the cervical spine, a measurement protocol with a CROM (CROM de Luxe, Performance Attainment Associates, Minnesota, USA) was used. It consists of 2 gravity inclinometers to measure cervical mobility in rotations, this one using a magnetic inclinometer.
Timepoint [3] 376436 0
72 hours after its application and 24 hours after its removal,

Eligibility
Key inclusion criteria
To participate in this study, the following inclusion criteria were required: patients of any gender, with ages between 18-50 years, suffering from chronic mechanical neck pain, that have not received manual treatment in the last month and that sign an informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following subjects were excluded: patients that presented a positive result to the orthopedic tests of Jackson, Valsalva, Spurling,, patients that have suffered a traffic accident, cervical arthrosis, pain under the shoulder girdle, positive signs of nerve compression, cervical and dorsal surgery and any other contraindication to the taping application.

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
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The PASW Statistics tool, version 18.0 (SPSS Inc., Chicago, IL) was used for the statistical analysis. The pain that was evaluated using the VAS scale for several parameters of cervical motion was transformed into a single variable, adding each of them. Similarly, the values of the cervical motion ranges in the different planes were added to obtain only one variable of cervical range of motion. A descriptive analysis of demographic data of the subjects participating in the study has been carried out. This descriptive analysis has also been performed for all the variables that were measured before the intervention, once the bandage was applied, after 3 days of treatment and 24 hours after the bandage was removed. The qualitative variable of gender is expressed as a relative frequency and the quantitative variables as average and standard deviation.
To compare the two groups at the beginning of the study, the unpaired t-Student test was used, for the quantitative variables. The chi-square test was used for the intergroup comparison of sex. To analyze the presence of intergroup differences regarding the effect of the interventions, an ANOVA of repeated measures was performed. In case that there were intergroup differences at the beginning of the study, the initial value was included as covariate.
Finally, the initial and final status of the total sample was compared using the t Student test. The tests have been considered bilaterally and with a statistically significant value of p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
1/08/2013
Date of last data collection
Anticipated
Actual
4/08/2013
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 21845 0
Spain
State/province [1] 21845 0
Madrid

Funding & Sponsors
Funding source category [1] 295455 0
Self funded/Unfunded
Name [1] 295455 0
Elena Sánchez Jiménez
Country [1] 295455 0
Spain
Primary sponsor type
Individual
Name
Elena Sánchez Jiménez
Address
Instituto Fyos Salud
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country
Spain
Secondary sponsor category [1] 294277 0
None
Name [1] 294277 0
Address [1] 294277 0
Country [1] 294277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296786 0
Comité Etico de Experimentación de la Universidad de Sevilla.
Ethics committee address [1] 296786 0
Edificio Pabellón de Brasil
Paseo de las Delicias, s/n
C.P: 41013(Sevilla)
Ethics committee country [1] 296786 0
Spain
Date submitted for ethics approval [1] 296786 0
Approval date [1] 296786 0
17/11/2012
Ethics approval number [1] 296786 0

Summary
Brief summary
The objective of this study is to analyze the effects in time of Kinesitaping (KT), immediately after its application, 72 hours after its application and 24 hours after its removal, in subjects with chronic mechanical neck pain who maintained the bandage for three days. As well, we aim to know if the effect of KT depends on the degree of tension applied to the bandage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72054 0
Dr Elena Sánchez Jiménez
Address 72054 0
Instituto Fyos Salud
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country 72054 0
Spain
Phone 72054 0
+34650331973
Fax 72054 0
Email 72054 0
[email protected]
Contact person for public queries
Name 72055 0
Dr Elena Sánchez Jiménez
Address 72055 0
Instituto Fyos Salud
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country 72055 0
Spain
Phone 72055 0
+34650331973
Fax 72055 0
Email 72055 0
[email protected]
Contact person for scientific queries
Name 72056 0
Dr Elena Sánchez Jiménez
Address 72056 0
Instituto Fyos Salud
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country 72056 0
Spain
Phone 72056 0
+34650331973
Fax 72056 0
Email 72056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no specific reason.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4634Ethical approval    372249-(Uploaded-08-09-2019-02-30-34)-Study-related document.pdf
4635Informed consent form    372249-(Uploaded-08-09-2019-02-37-11)-Study-related document.rtf
4636OtherInformation sheet   Information sheet 372249-(Uploaded-08-09-2019-02-38-26)-Study-related document.doc



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.