Myofascial PainKT/TrP/TMDNCT03398486
The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD
A study testing Kinesiotaping and inactivation of trigger points (TrP) in people with Myofascial Pain and TMD, run by Pomeranian Medical University Szczecin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Myofascial Pain, TMD
- What is being tested?
- Kinesiotaping and inactivation of trigger points (TrP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- One absence during therapeutic sessions;
About this study
Official title: Evaluation of the Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of Temporomandibular Joint Dysfunction
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.
Read the 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.
- Conditions
- Myofascial Pain, TMD
- Being tested
- Kinesiotaping, inactivation of trigger points (TrP)
- Keywords
- Kinesiotaping, Manual therapy, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDiagnostic test
Also called Dynamic adhesive plaster, Dynamic adhesive tape
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.
inactivation of trigger points (TrP)Diagnostic test
Also called compressive mobilization
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Kinesiotaping |
| inactivation of trigger points (TrP) | Experimental | Duration: 10-20 minutes of surgery; 2 inactivation treatments Between the treatments 5 days break Receives: Diagnostic Test: inactivation of trigger points (TrP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start2 Oct 2016
- Primary completion15 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Responsible party
- Principal investigator, Edward Kijak, Pomeranian Medical University Szczecin
- Investigators
- Edward S Kijak, DSc, Study director, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398486
- Sponsor's protocol ID
- KB-0012/36/15
- Acronym
- KT/TrP/TMD
- Status last verified
- Jan 2018
- First submitted
- 7 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03398486
- Acronym / sponsor ID
- KT/TrP/TMD / KB-0012/36/15
- Conditions
- Myofascial Pain, TMD
- Keywords
- Kinesiotaping, Manual therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Diagnostic Test: KinesiotapingOriginal 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. |
| inactivation of trigger points (TrP) | Experimental | Diagnostic Test: inactivation of trigger points (TrP)Duration: 10-20 minutes of surgery; 2 inactivation treatments Between the treatments 5 days break |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- One absence during therapeutic sessions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingAlso: Dynamic adhesive plaster, Dynamic adhesive tapeDynamic 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. | Diagnostic test | Kinesiotaping |
| inactivation of trigger points (TrP)Also: compressive mobilizationA 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. | Diagnostic test | inactivation of trigger points (TrP) |
Primary outcome
1. Change from baseline in Visual Analogic Scale
Time frame: 14 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward S Kijak, DSc study director
Pomeranian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and inactivation of trigger points (TrP) in people with Myofascial Pain and TMD, run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change from baseline in Visual Analogic Scale (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.