Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001129976
Ethics application status
Not yet submitted
Date submitted
25/10/2011
Date registered
28/10/2011
Date last updated
14/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of bilateral neuromuscular taping on upper trapezius muscle in patients with chronic mechanical neck pain.
Scientific title
Immediate effects of bilateral neuromuscular taping on upper trapezius muscle in patients with chronic mechanical neck pain.
Secondary ID [1] 273263 0
Nill
Universal Trial Number (UTN)
U1111-1125-3945
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic mechanical neck pain 279029 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279214 279214 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 upper trapezius (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 acromion process to the hairline at the base of the occiput. 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 upper trapezium 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 just distal and anterolateral to the edge of the acromion 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 and rotate the head and neck to the opposite side. Place your hand on the acromion process and the underlying skin inferiorly and laterally while depressing the shoulder to increase tissue tension. Apply the superior “Y” tail to the hairline at the base of the occiput. Apply the inferior “Y” tail to the spinous process of the 4th-5th cervical vertebra.

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

Both upper trapecius muscles were taping.

Measurements were recorded inmediately after applying the tape with the tape on the skin. Only once time.
Intervention code [1] 269605 0
Rehabilitation
Intervention code [2] 269615 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 acromion process to the hairline at the base of the occiput.

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 edge of the acromion process. The superior “Y” tail was applied to the upper-cervical region and the inferior “Y” tail was applied to the spinous process of 4th- 5th cervical vertebra. 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] 279846 0
1st Primary outcome: Check that the application of neuromuscular taping bilaterally on upper trapezius 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 upper trapezius muscle.
Measurements were performed by three therapist. Each therapist performed the measurement three times.
Timepoint [1] 279846 0
After picture was taken and VAS was recorded at resting state; first measurement was made by the therapist number 1. He repated two more times algometry.
after this, second therapist perfomed algometry
and finally, third therapist.
Primary outcome [2] 279847 0
2nd Primary outcome : Check that the application of neuromuscular taping bilaterally on upper trapezius 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] 279847 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] 279848 0
3rd Primary Outcome 3: Check that the bilateral application of neuromuscular taping on upper trapezius 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 three therapist.
Timepoint [3] 279848 0
Cervical Range of motion was assessed after picture was taken, algometry was measured by three therapist (each therapist performed the measurements three times) and VAS was assessed at resting state.
Measurements was assessed by therapist 1 (three times each movement).
After therapist 1, therapist 2 performed the measurements (three time each movement).
After therapist 2, therapist 3 performed the measurements (three time each movement).
Secondary outcome [1] 294570 0
Secundary outcome: Check that the bilateral application of neuromuscular taping on upper trapezium 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 three therapist. Each therapist performed the measurement three times.
Timepoint [1] 294570 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 three 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
Be under 18 years and more than 45 years.
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.
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.
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
15/11/2011
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] 3925 0
Spain
State/province [1] 3925 0
Madrid

Funding & Sponsors
Funding source category [1] 284092 0
Commercial sector/Industry
Name [1] 284092 0
ENRAF NONIUS
Country [1] 284092 0
Spain
Primary sponsor type
Individual
Name
Sandra Sanchez Jorge
Address
Calle Navia 10, portal D, 3B
28024 Madrid
Country
Spain
Secondary sponsor category [1] 269055 0
Individual
Name [1] 269055 0
Sandra Sanchez Jorge
Address [1] 269055 0
calle Navia 10, portal D, 3B
28044 Madrid
Country [1] 269055 0
Spain

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 272042 0
Facultad de Fisioterapia de la Universidad de Sevilla
Ethics committee address [1] 272042 0
Ethics committee country [1] 272042 0
Spain
Date submitted for ethics approval [1] 272042 0
21/10/2011
Approval date [1] 272042 0
Ethics approval number [1] 272042 0

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

Contacts
Principal investigator
Name 33303 0
Address 33303 0
Country 33303 0
Phone 33303 0
Fax 33303 0
Email 33303 0
Contact person for public queries
Name 16550 0
Sandra Sanchez Jorge
Address 16550 0
Calle Navia 10, portal D, 3B
28044 Madrid
Country 16550 0
Spain
Phone 16550 0
0034-619148937
Fax 16550 0
Email 16550 0
[email protected]
Contact person for scientific queries
Name 7478 0
Angel Oliva Pascual-Vaca
Address 7478 0
Avda. Sanchez Pizjuan s/n
41009 Sevilla
Country 7478 0
Spain
Phone 7478 0
0034-630254399
Fax 7478 0
Email 7478 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
No additional documents have been identified.