Trial from ANZCTR


Trial ID ACTRN12611001176954
Trial Status: Registered
Date Submitted: 7/11/2011
Date Registered: 11/11/2011
Prospectively registered

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Public title Immediate effects of bilateral neuromuscular taping on sternocleidomastoid muscle in patients with chronic mechanical neck pain.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Immediate effects of bilateral neuromuscular taping on sternocleidomastoid muscle in patients with chronic mechanical neck pain.
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Secondary ID [1] 273349 0
Nill
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UTN U1111-1125-4545
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Trial acronym
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Health condition(s) or problem(s) studied:
chronic mechanical neck pain 279117 0
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Condition category: Condition code:
Physical Medicine / Rehabilitation Physiotherapy
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279311 279311 0 0

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Descriptions 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.
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Intervention Code:
Rehabilitation 283690 0
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Intervention Code:
Treatment: Other 283691 0
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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.
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Control group Placebo
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Primary Outcome: 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
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Timepoint: After picture was taken and VAS was recorded at resting state. 279919 0
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Primary Outcome: 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. 279920 0
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Timepoint: Before algometry, when patient was at resting state VAS was recorded.
While cervical range of motion was assessed, VAS was recorded in each movement
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Primary Outcome: 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
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Timepoint: 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. 279921 0
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Secondary Outcome: 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.
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Timepoint: 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
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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
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Minimum age 18 Years
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Maximum age 45 Years
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Gender Both males and females
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Healthy volunteers? No
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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
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 22/11/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 60
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: Spain 3942 0
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State/Province: Madrid 3942 0
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Funding Source: Commercial sector/Industry 284174 0
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Name: ENRAF NONIUS 284174 0
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Address: Calle F, numero 15. Poligono industrial.Mostoles 28938.Madrid 284174 0
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Country: Spain 284174 0
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Primary Sponsor Individual
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Name: Elena Sanchez Jimenez
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Address: Calle Empecinado 14, bajo local.
28937Mostoles
Madrid
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Country: Spain
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Secondary Sponsor: None 269128 0
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Name: 269128 0
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Address: 269128 0
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Country: Sudan 269128 0
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Has the study received approval from at least one Ethics Committee? No
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Ethics Committee name: Facultad de Fisioteraoia de la Universidad de Sevilla 286133 0
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Address: Avda. Sanchez Pijuan s/n
41009 Sevilla
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Country: Spain 286133 0
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Approval Date: 286133 0
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Submitted Date: 21/11/2011 286133 0
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HREC: 286133 0
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Ethics Committee name: 286150 0
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Address: 286150 0
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Country: Spain 286150 0
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Approval Date: 286150 0
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Submitted Date: 21/11/2011 286150 0
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HREC: 286150 0
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Brief summary Researchers begun to investigate the effects of neuromuscular taping on different musculoskeletal conditions (eg, shoulder and trunk pain). Considering the demonstrated short-term effectiveness of neuromuscular tape for the management of shoulder pain, this suggest that this kind of tape may also be beneficial in reducing pain in patients with chronic mechanical neck pain.

It was a randomized clinical trial.

The main objective of this trial was to determine the immediate effects of neuromuscular taping applied bilaterally on upper trapezius muscle: neck pain, cervical range of motion and head position in patients with chronic mechanical neck pain
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Elena Sanchez Jimenez
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Address: Calle Empecinado 14, bajo local. 28937 Mostoles Madrid
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Tel: 0034-650331973
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Email: elesanji@hotmail.com
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Contact person for scientific queries
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Name: Angel Oliva Pascual-Vaca
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Address: Avda. Sanchez Pizjuan s/n
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Country: Spain
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Tel: 0034-6300254399
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Email: angeloliva@us.es
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Contact person responsible for updating information
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Name: Elena Sanchez Jimenez
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Address: Calle Empecinado 14, bajo local. 28937 Mostoles Madrid
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Country: Spain
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Tel: 0034-650331973
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Email: elesanji@hotmail.com
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Addition Cancer fields
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