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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913976
Other study ID # CEU Cardenal Herrera
Secondary ID
Status Completed
Phase N/A
First received September 18, 2016
Last updated December 21, 2016
Start date October 2016
Est. completion date December 2016

Study information

Verified date September 2016
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to demonstrate that the application of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain.


Description:

The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal disorders in recent decades. Of the six variants of application that has the Kinesio Taping, the space correction technique is suggested for pain management. The increased space achieved with this variant decreases the pressure by raising the skin directly over the treatment area, reducing chemical irritation receptors and therefore pain. The aim of this study is to demonstrate that the application of this variant of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in patients diagnosed with cervical pain. For this, the pressure pain threshold will be measured with a algometer on the trigger point, the perception of pain with a visual analog scale and the range of motion with a cervical goniometer.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Agree to participate in the study (signed informed consent)

- Presence of active myofascial trigger point in upper trapezius.

- Presence of neck pain

Exclusion Criteria:

- Subjects in which not clearly identified myofascial trigger point in the upper trapezius .

- Subjects who suffer or have suffered pathologies of upper limb deformities or orthopedic injuries that can alter static and biomechanics of shoulder and neck.

- Subjects who suffer or have suffered rheumatic or neurological disease or chronic shoulder pain and/or neck

- Subjects diagnosed with fibromyalgia, myelopathy or radiculopathy.

- Subjects suffering from any psychiatric disorder (such as anxiety or depression).

- Subjects who have suffered post-traumatic alteration (whiplash type) or cervical surgery.

- Pregnancy risk of abortion.

- Have used analgesics in the 48 hours before participating in the study

- Subjects presenting any contraindications to the application of Kinesio Taping.

- Know the Kinesio Taping technique applied in the study.

- Be receiving physical therapy for any shoulder or neck pathology.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Device:
Kinesio Taping
Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
Sham Kinesio Taping
Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin

Locations

Country Name City State
Spain CEU Cardenal Herrera University Moncada Valencia

Sponsors (1)

Lead Sponsor Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Akamatsu FE, Ayres BR, Saleh SO, Hojaij F, Andrade M, Hsing WT, Jacomo AL. Trigger points: an anatomical substratum. Biomed Res Int. 2015;2015:623287. doi: 10.1155/2015/623287. — View Citation

Ekiz T, Aslan MD, Özgirgin N. Effects of Kinesio Tape application to quadriceps muscles on isokinetic muscle strength, gait, and functional parameters in patients with stroke. J Rehabil Res Dev. 2015;52(3):323-31. doi: 10.1682/JRRD.2014.10.0243. — View Citation

Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. — View Citation

Gusella A, Bettuolo M, Contiero F, Volpe G. Kinesiologic taping and muscular activity: a myofascial hypothesis and a randomised, blinded trial on healthy individuals. J Bodyw Mov Ther. 2014 Jul;18(3):405-11. doi: 10.1016/j.jbmt.2013.11.007. — View Citation

Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. — View Citation

Silva Parreira Pdo C, Menezes Costa Lda C, Takahashi R, Hespanhol Junior LC, Motta Silva T, da Luz Junior MA, Pena Costa LO. Do convolutions in Kinesio Taping matter? Comparison of two Kinesio Taping approaches in patients with chronic non-specific low back pain: protocol of a randomised trial. J Physiother. 2013 Mar;59(1):52; discussion 52. doi: 10.1016/S1836-9553(13)70147-4. — View Citation

Vanderweeën L, Oostendorp RA, Vaes P, Duquet W. Pressure algometry in manual therapy. Man Ther. 1996 Dec;1(5):258-265. — View Citation

Walton DM, Levesque L, Payne M, Schick J. Clinical pressure pain threshold testing in neck pain: comparing protocols, responsiveness, and association with psychological variables. Phys Ther. 2014 Jun;94(6):827-37. doi: 10.2522/ptj.20130369. — View Citation

Wu WT, Hong CZ, Chou LW. The Kinesio Taping Method for Myofascial Pain Control. Evid Based Complement Alternat Med. 2015;2015:950519. doi: 10.1155/2015/950519. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in pressure pain threshold Is defined as the minimum force applied which induces pain on myofascial trigger point. Pressure will be applied with algometer At the beginning, immediately after intervention and at 72 hours No
Secondary Changes in pain perception It is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Will be measured with a visual analog scale At the beginning, immediately after intervention and at 72 hours No
Secondary Changes in cervical range of motion Cervical range of motion is measuring movement around this segment of the spine. Lateral flexion and rotation. Will be measured with a cervical goniometer At the beginning, immediately after intervention and at 72 hours No
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