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
About this trial
This is an interventional treatment trial for Myofascial Pain focused on measuring Kinesiotaping, Manual therapy, Physiotherapy
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;
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
NCT ID
NCT03398486
First Posted
January 7, 2018
Last Updated
January 11, 2018
Sponsor
Pomeranian Medical University Szczecin
Collaborators
Ministry of Health, Poland
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
Learn more about this trial
The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD
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