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The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD (KT/TrP/TMD)

Primary Purpose

Myofascial Pain, TMD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesiotaping
inactivation of trigger points (TrP)
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain focused on measuring Kinesiotaping, Manual therapy, Physiotherapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • One absence during therapeutic sessions;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Kinesiotaping

    inactivation of trigger points (TrP)

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2018
    Last Updated
    January 11, 2018
    Sponsor
    Pomeranian Medical University Szczecin
    Collaborators
    Ministry of Health, Poland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03398486
    Brief Title
    The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD
    Acronym
    KT/TrP/TMD
    Official Title
    Evaluation of the Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of Temporomandibular Joint Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2, 2016 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    September 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pomeranian Medical University Szczecin
    Collaborators
    Ministry of Health, Poland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of signs and symptoms that may include joint noise, pain in the mastication muscles, limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain appears as a very present and striking symptom, with a tendency to chronicity. This is a difficult treatment condition often associated with psychological factors such as anxiety. In patients with a longlasting TMD syndrome, especially those of a muscular nature, palpation can locate the trigger points of pain (TrP) in the chewing muscles, i.e. the nodules in the shape of bumps the size of grains of rice or peas. Of particular importance in the treatment of pain syndromes of temporomandibular joint disorders is physiotherapy and physical therapy. Some studies have shown improvement in subjects with chronic pain using different physiotherapy treatments, but this requires further investigation to determine the effectiveness of individual therapies in the fight against pain. PROBLEM: The multiple manifestation of symptoms causes a multitude of treatment methods and indicates that there is still no consensus in the understanding of the pathophysiology of the underlying TMD mechanisms. Treatment of pain syndrome in temporomandibular dysfunction due to heterogeneity of causes should have a multiprofile character. Despite the wide range of strategies used to treat patients with TMD, some patients have a temporary and / or unsatisfactory relief response. There are many physiotherapeutic methods to fight pain, among others: compressive mobilization, positional release, myofascial relaxation, active relaxation technique, postisometric relaxation technique. Of the commonly used methods, a deep tissue massage and stretching. Some of them are very unpleasant for patients, because in the first phase they intensify pain, eg active inactivation (therapy) of trigger points (TrP). Kinesiotaping is a painless method that does not intensify pain symptoms. Reports from various researchers are contradictory in this regard, hence the attempt to compare both methods in the aspect of non-pharmacological analgesic activity in patients with TMD. HYPOTHESIS: Researchers believe that in patients with severe pain symptoms, patients with TMD who are often accompanied by anxiety before symptom intensification, it is very important to use physiotherapeutic methods, which can eliminate or reduce pain in a non-pharmacological manner. In this type of patients, the psychological aspect is important in the form of immediate relief without aggravating the symptoms at least in the first phase, because it can cause patients psychological reluctance to the entire treatment process. Because of the mutual influence between pain and psychological factors, it is expected that the analgesic effect will have a positive effect influence on the level of anxiety before further often long-term therapeutic treatment. AIM: Evaluation and comparison of the analgesic efficacy of two physiotherapeutic methods: Kinsiotapinng (KT) and active inactivation of trigger points (TrP) in the pain levels in individuals with chronic pain due muscular TMD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain, TMD
    Keywords
    Kinesiotaping, Manual therapy, Physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesiotaping
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    inactivation of trigger points (TrP)
    Arm Type
    Experimental
    Arm Description
    Duration: 10-20 minutes of surgery; 2 inactivation treatments Between the treatments 5 days break
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Kinesiotaping
    Other Intervention Name(s)
    Dynamic adhesive plaster, Dynamic adhesive tape
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    inactivation of trigger points (TrP)
    Other Intervention Name(s)
    compressive mobilization
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    1. Change from baseline in Visual Analogic Scale
    Description
    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.
    Time Frame
    14 days
    Other Pre-specified Outcome Measures:
    Title
    1. Patient Global Impression of Change Scale (PGICS)
    Description
    The Patient Global Impression of Change Scale (PGICS) is an understandable, adequate, easy-to-use instrument capable of measuring the perception of change in health status and satisfaction with the treatment of individuals with chronic musculoskeletal pain. It is a one-dimensional measurement instrument in which individuals rate their improvement associated with intervention on a 7-item scale ranging from 1 (no change) to 7 (Much better).
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: One absence during therapeutic sessions;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward S Kijak, DSc
    Organizational Affiliation
    Pomeranian Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD

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