NCT03398486

Brief Summary

In patients with a long-lasting TMD syndrome, especially of a muscular nature, palpation examination can locate the trigger points of pain (TrP) in the chewing muscles, i.e., the nodules in the shape of bumps the size of rice or pea grains. Kinesiotaping (KT) is considered as an intervention method that can be used to release latent myofascial trigger points. It is a method that involves applying specific tapes to the patient's skin surface in order to use the natural self-healing processes of the body. The aim of the study was to evaluate the effect of Kinesiotaping methods and inactivation of Trigger Points on nonpharmacological elimination of pain in patients with functional disorders of the masticatory motor system.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

January 7, 2018

Last Update Submit

January 11, 2018

Conditions

Keywords

Kinesiotaping, Manual therapyPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 1. Change from baseline in Visual Analogic Scale

    The visual analogic scale allows us to convert subjective sensations as pain on numerical data. A 10cm scale where 0cm is no pain and 10cm the worse imaginable pain, will be used and the subjects will be asked to mark a point on the scale representing their pain. This instrument will be used to compare the VAS values before and after the intervention.

    14 days

Other Outcomes (1)

  • 1. Patient Global Impression of Change Scale (PGICS)

    3 months

Study Arms (2)

Kinesiotaping

EXPERIMENTAL

Original kinesiotaping active tapes Duration: 2 times Application maintenance 5 days with a break for the weekend Muscle application on the masseter muscle area, using a tape (5 cm wide) dissected into 2 parts called tails, which included the treatment site without their tension.

Diagnostic Test: Kinesiotaping

inactivation of trigger points (TrP)

EXPERIMENTAL

Duration: 10-20 minutes of surgery; 2 inactivation treatments Between the treatments 5 days break

Diagnostic Test: inactivation of trigger points (TrP)

Interventions

KinesiotapingDIAGNOSTIC_TEST

Dynamic adhesive taping is a method that involves the application of specific tapes to the surface of the patient's skin in order to use the natural self-healing processes of the body. It is often used as an element that sustains the therapeutic effect. Its action is based mainly on the action normalizing muscle tone, supporting the work of joints, improving the function of weakened muscles, increasing microcirculation at the site of application.

Also known as: Dynamic adhesive plaster, Dynamic adhesive tape
Kinesiotaping

A procedure for releasing trigger points using physiotherapy using the ischemic compression method, which involves applying pressure to the active trigger point, until it is switched off, i.e. pain ceases.The location of the trigger point is done palpatively, with a pliers grip, covering the strained tissue on the inside and outside of the cheek with the thumb and index finger.

Also known as: compressive mobilization
inactivation of trigger points (TrP)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-35 years, both male and female
  • Provide informed consent to participate in the study;
  • Having a diagnosis of muscular pain TMD(Temporomandibular Disorders) according to group -I A, axis I RDC/TMD(Research Diagnostic Criteria)
  • Visual analogic scale (VAS) score from 4 to 10 for 14 days
  • Not have history of alcohol or drugs abuse within the past 6 months as self-reported
  • Not use ot carbamazepine (or similar) within the past 6 months as self reported
  • Not have history of neurosurgery as self-reported
  • Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
  • Not have any other previously diagnosed disorder with symptoms similar to the TMD, such as fibromyalgia.

You may not qualify if:

  • One absence during therapeutic sessions;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Edward S Kijak, DSc

    Pomeranian Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. Experimental: Kinesiotaping Participants receive an application of active tapes (KT) Original kinesiotaping active tapes Duration: 2 times Application maintenance 5 days with a break for the weekend Muscle application on the masseter muscle area, using a tape (5 cm wide) dissected into 2 parts called tails, which included the treatment site without their tension. Experimental: active inactivation of trigger points (TrP) Duration: 10-20 minutes of surgery; 2 inactivation treatments Between the treatments 5 days break
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 12, 2018

Study Start

October 2, 2016

Primary Completion

June 15, 2017

Study Completion

September 30, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share