NCT02913963

Brief 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 trigger point pain and an increase of the cervical range of motion in asymptomatic subjects

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

September 18, 2016

Last Update Submit

November 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in cervical range of motion

    At the beginning, immediately after intervention and at 72 hours

Study Arms (2)

Kinesio Taping

ACTIVE COMPARATOR

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

Device: Kinesio Taping

Sham Kinesio Taping

PLACEBO COMPARATOR

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

Device: Sham Kinesio Taping

Interventions

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

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

Sham Kinesio Taping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agree to participate in the study (signed informed consent)
  • Presence of latent myofascial trigger point in upper trapezius.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 23419916BACKGROUND
  • Ekiz T, Aslan MD, Ozgirgin 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.

    PMID: 26220179BACKGROUND
  • 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. Epub 2013 Nov 8.

    PMID: 25042311BACKGROUND
  • 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. Epub 2015 Jun 21.

    PMID: 26185522BACKGROUND
  • 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. doi: 10.1016/s0304-3959(96)03248-4.

    PMID: 9060014BACKGROUND
  • 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. Epub 2015 Feb 24.

    PMID: 25811029BACKGROUND
  • Vanderweeen L, Oostendorp RA, Vaes P, Duquet W. Pressure algometry in manual therapy. Man Ther. 1996 Dec;1(5):258-265. doi: 10.1054/math.1996.0276.

    PMID: 11440515BACKGROUND
  • 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. Epub 2014 Feb 20.

    PMID: 24557645BACKGROUND

MeSH Terms

Conditions

Mobility LimitationMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • F Javier Montañez-Aguilera, PhD

    CEU Cardenal Herrera University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 26, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share