Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001176954
Ethics application status
Not yet submitted
Date submitted
7/11/2011
Date registered
11/11/2011
Date last updated
11/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of bilateral neuromuscular taping on sternocleidomastoid muscle in patients with chronic mechanical neck pain.
Scientific title
Immediate effects of bilateral neuromuscular taping on sternocleidomastoid muscle in patients with chronic mechanical neck pain.
Secondary ID [1] 273349 0
Nill
Universal Trial Number (UTN)
U1111-1125-4545
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic mechanical neck pain 279117 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279311 279311 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomly assigned to 1 of 2 groups: the experimental group received neuromuscular taping on sternocleidomastoid (applied with tension) and the placebo group received a sham neuromuscular taping application (applied without tension).

Intervention group (Group 1):

The tape used in this study was waterproof, porous, and adhesive. Its color was beige. Tape with a width of 5 cm and a thickness of 0.5 mm was used in both groups. The tape measure was the distance from the mastoid process to sternoclavicular joint. The experimental group received a standardized therapeutic Kinesio Tape application described by Kenso Kase.

Patients were sitting during the tape application.

The layer was a Y-strip placed on sternocleidomastoid muscle and applied from the insertion to origin with paper-off tension.

A trained physiotherapist applied the tape following this instructions: Apply the base of the tape to the mastoid process.. Pell the tape from the paper liner and place the tape temporarily on the skin. Do not activate the glue by rubbing. Laterally flex the neck to the opposite side.Apply the lateral "Y" tail to the medial 1/3 of the clavicle.Rotate tothe head to the same side while maintaining lateralflexion to the opposite side.Apply the medial "Y" tail to the sternal-notch

The paper-off tension tape was applied with approximately 15% stretch.

Both sternocleidomastoid muscles were taping.

Measurements were recorded inmediately after applying the tape with the tape on the skin. Only once time. Measurements are performed immediately after the application, a picture was taken (patient sitting and then standing), VAS was recorded in rest, then algometry in the trigger point of the sternocleidomastoid muscle and finally the cervical range of motion.This process of measurement will last approximately 1-2 minutes.
Intervention code [1] 283690 0
Rehabilitation
Intervention code [2] 283691 0
Treatment: Other
Comparator / control treatment
Control group (group 2): The sham group received a placebo neuromuscular tape application. The tape used was waterproof, porous, and adhesive. Its color was beige. Tape with a width of 5 cm and a thickness of 0.5 mm was used in both groups. The tape measure was the distance from the mastoid process to sternoclavicular joint. Patients were sitting during the tape application. A trained physiotherapist applied the tape. The placebo taping was one Y-strip. The base of the tape was applied to the mastoid process. The lateral “Y” tail was applied to the medial 1/3 of the clavicle.The medial "Y" tail was applied sternoclavicular joint .We used the same material as group 1, but it was applied with no tension. For the placebo taping, the participant’s cervical spine was placed in a neutral position. Both tape applications looked very similar, but the placebo group had no tension applied on the cervical spine.
Control group
Placebo

Outcomes
Primary outcome [1] 279919 0
1st Primary outcome: Check that the application of neuromuscular taping bilaterally on sternocleidomastoid muscle decrease pain at the trigger point 1 (PG1) in patients with chronic mechanical neck pain compared with the control group.

This first outcome was measured using a manual algometer on the trigger point 1 of the sternocleidomastoid muscle.
Measurements were performed by one therapist. The therapist performed the measurement three times
Timepoint [1] 279919 0
After picture was taken and VAS was recorded at resting state.
Primary outcome [2] 279920 0
2nd Primary outcome : Check that the application of neuromuscular taping bilaterally on sternocleidomastoid muscle decrease neck pain at resting state and during movement of the cervical spine (flexion, extension, bending and rotation) recorded by visual analogue scale (VAS) in patients with chronic mechanical neck pain compared with the control group.
Timepoint [2] 279920 0
Before algometry, when patient was at resting state VAS was recorded.
While cervical range of motion was assessed, VAS was recorded in each movement
Primary outcome [3] 279921 0
3rd Primary Outcome 3: Check that the bilateral application of neuromuscular taping on sternocleidomastoid muscle increases cervical range of motion in patients with chronic mechanical neck pain patients compared with control group.

Cervical range of motion was assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90 degress of flexion, and buttocks positioned against the back of the chair. A cervical range-of-motion (CROM) device was placed on the top of the head, and the patient was asked to move the head as far as possible without pain in a standard fashion: flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation. Three trials were conducted for each direction of movement, and the mean values of the 3 trials were recorded for analysis.

Measurements were performed by one therapist
Timepoint [3] 279921 0
Cervical Range of motion was assessed after picture was taken, algometry was measured by one therapist (the therapist performed the measurements three times) and VAS was assessed at resting state.
Secondary outcome [1] 294779 0
Secundary outcome: Check that the bilateral application of neuromuscular taping on sternocleidomastoid muscle modifies the cranio-cervical angle in patients with chronic mechanical neck pain compared to the control group.

Cranio-cervical angle was assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90 degree of flexion, and buttocks positioned against the back of the chair. A picture was taken.

Another picture was taken with the patients standing.

Cranio-cervical angle is formed between the horizontal and a line passing through the spinous process of seventh cervical vertebra and the tragus

Cranio-cervical angle was measured by one therapist. The therapist performed the measurement three times.
Timepoint [1] 294779 0
A picture was taken inmediately after applying the tape.
(patient sitting and the standing).

Cranio-Cervical angle was measured using the same pictures by one therapist

Eligibility
Key inclusion criteria
Men and women aged between 18 and 45.
Subjects diagnosed with chronic mechanical neck pain, checking it as widespread pain in the neck and or shoulders with mechanical properties, whose pain increases with the positions held, with the movement and or palpation of the spinal musculature for more than three months
Pain located between the occiput and the third dorsal vertebra
More than 3 moths of pain evolution
Informed consent signed
Do not meet any exclusion criteria
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Positive orthopedic diagnostic test
Patients with a history of whiplash
Patients diagnosed with cervical osteoarthritis.
Patients who are carrying out another parallel treatment for the condition being treated.
Patients with pain radiation below the shoulder girdle and / or patients with bilateral irradiation on both upper limbs.
Positive signs of nerve compression, hypo-reflexia, and sensitivity alteration in the dermatomes of upper limb.
Cervical surgery and / or dorsal
Refusal to participate in the study.
Presence of any contraindications to the implementation of neuromuscular taping:
Wound: not be placed on wounds because bands are not sterile
Severe trauma
general edema (swelling dynamic) caused by heart or kidney problems.
Cancer
Material used allergy.
Pregnancy.
Diabetes: Taping should not be placed in areas of insulin administration and never in a diabetic foot

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)
Following the baseline examination, patients were randomly assigned to receive neuromuscular taping to the cervical spine (experimental group) or a placebo neuromuscular tape application (sham group). Concealed allocation was performed using a random sampling sealed envelope. We prepared “X” envelopes, half of them contain the number 1 and the other half contain the number 2 , we mixed and participants randomly chose one of them. Two groups were formed. Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): This trial used simple randomization. Participants moved envelopes randomly and chose one of them. Formed two groups as a result. One group was the interventional group formed by patients with neck pain who are going to receive a standardized therapeutic Kinesio Tape application described by Kenso Kase. The other group (sham group) was formed by patients with neck pain who are going to receive a placebo neuromuscular tape application
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3942 0
Spain
State/province [1] 3942 0
Madrid

Funding & Sponsors
Funding source category [1] 284174 0
Commercial sector/Industry
Name [1] 284174 0
ENRAF NONIUS
Country [1] 284174 0
Spain
Primary sponsor type
Individual
Name
Elena Sanchez Jimenez
Address
Calle Empecinado 14, bajo local.
28937Mostoles
Madrid
Country
Spain
Secondary sponsor category [1] 269128 0
None
Name [1] 269128 0
Address [1] 269128 0
Country [1] 269128 0
Sudan

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286133 0
Facultad de Fisioteraoia de la Universidad de Sevilla
Ethics committee address [1] 286133 0
Ethics committee country [1] 286133 0
Spain
Date submitted for ethics approval [1] 286133 0
21/11/2011
Approval date [1] 286133 0
Ethics approval number [1] 286133 0
Ethics committee name [2] 286150 0
Ethics committee address [2] 286150 0
Ethics committee country [2] 286150 0
Spain
Date submitted for ethics approval [2] 286150 0
21/11/2011
Approval date [2] 286150 0
Ethics approval number [2] 286150 0

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

Contacts
Principal investigator
Name 33364 0
Address 33364 0
Country 33364 0
Phone 33364 0
Fax 33364 0
Email 33364 0
Contact person for public queries
Name 16611 0
Elena Sanchez Jimenez
Address 16611 0
Calle Empecinado 14, bajo local.
28937 Mostoles
Madrid
Country 16611 0
Spain
Phone 16611 0
0034-650331973
Fax 16611 0
Email 16611 0
[email protected]
Contact person for scientific queries
Name 7539 0
Angel Oliva Pascual-Vaca
Address 7539 0
Avda. Sanchez Pizjuan s/n
Country 7539 0
Spain
Phone 7539 0
0034-6300254399
Fax 7539 0
Email 7539 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3930Plain language summaryNo Intra-group statistically significant interaction ... [More Details]

Documents added automatically
No additional documents have been identified.