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Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism

Primary Purpose

Bruxism

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Therapy
Kinesio Taping
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism focused on measuring Bruxism, Manual Therapy, Kinesio Taping, Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders
  • Self-report of awake bruxism

Exclusion Criteria:

  • Having more than 2 missing teeth
  • The presence of removable partial dentures
  • Having neurological, psychiatric or motor disorders
  • Having any ongoing dental or physical therapy
  • Active cancer

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual Therapy

Kinesio Taping

Arm Description

Manual Therapy is a widely used physiotherapy modality which is known to be effective in the management of musculoskeletal problems . Manual Therapy is a passive, therapeutic approach used to target a variety of anatomical structures with the intent to create beneficial changes in the amount of pain a patient experiences. Manual Therapy includes joint mobilization, manipulation, or treatment of the soft tissues and is widely used to break fibrous adhesions, restore normal range of motion, reduce local ischemia, stimulate synovial fluid production, and reduce pain .

Kinesio tape is a type of elastic therapeutic tape that was developed which is used in many different situations with various aims. Advocates of Kinesio Tape state that it may promote different therapeutic objectives such as; improved circulation and lymphatic drainage, pain inhibition, reduction of delayed onset of muscle soreness or improvement in performance and coordination .

Outcomes

Primary Outcome Measures

Pain Pressure Threshold of Masseter Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the masseter muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Pain Pressure Threshold of Trapezius Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the trapezius muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Pain Pressure Threshold of Temporalis Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the temporalis muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.

Secondary Outcome Measures

Sleep Quality
The Pittsburgh Sleep Quality Index is an index widely used to measure sleep quality. The Pittsburgh Sleep Quality Index is a self-reported questionnaire that includes 19 questions that when scored, are separated into seven domains. The seven domains are; perceived sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications; and daytime dysfunction. Each domain is scored from 0-3 and a total score ranging from 0-21 can be obtained. A total score of; 0-4 indicates a good sleep quality, 5-10 indicates poor sleep quality and scores above 10 indicate a possible sleep disorder.

Full Information

First Posted
April 23, 2020
Last Updated
April 24, 2020
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04363931
Brief Title
Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism
Official Title
Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
April 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

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
Bruxism is defined as a repetitive jaw-muscle activity characterized by tooth grinding or clenching accompanied with wearing of the teeth, and jaw muscle discomfort in the absence of a medical disorder . Bruxism has two distinct circadian manifestations: it can be nocturnal or diurnal. Hypertrophy of the masseter muscle is an objective sign of bruxism. Additionally, fatigue or stiffness in the masticatory muscles, pain in the temporomandibular joint or headaches are subjective signs of bruxism. According to literature, 85% to 90% of the general population experience episodes of bruxism during their lives. Thus, finding an effective treatment method for bruxism is crucial.The aim of this study is to investigate the effects of two different physiotherapy approaches on the masseter muscle thickness and stiffness in patients with Bruxism.
Detailed Description
There is no certain treatment for Bruxism. However, the most recent recommendation is to follow the Multiple-P approach prior to medical drug regimens and invasive procedures. Different methods used in the conservative management of Bruxism are known as the "multiple-P" approach, which consists of; physiotherapy, plates, pep talk, pills and psychology . Physiotherapy generally focuses on two objectives: decreasing the adverse effects of bruxism to the masticatory muscles and increasing self-awareness regarding this habit. These studies involve different intervention such as massage of the masticatory and cervical muscles, electrotherapy, therapeutic exercises, taping interventions or relaxation therapies . However, literature regarding which physiotherapy intervention is the most effective in bruxism is not clear. Therefore patients in this study were randomly divided into one of two groups; manual therapy or kinesio taping. All patients were assessed at baseline, received 4 weeks of treatment and were assessed following the 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
Keywords
Bruxism, Manual Therapy, Kinesio Taping, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
Manual Therapy is a widely used physiotherapy modality which is known to be effective in the management of musculoskeletal problems . Manual Therapy is a passive, therapeutic approach used to target a variety of anatomical structures with the intent to create beneficial changes in the amount of pain a patient experiences. Manual Therapy includes joint mobilization, manipulation, or treatment of the soft tissues and is widely used to break fibrous adhesions, restore normal range of motion, reduce local ischemia, stimulate synovial fluid production, and reduce pain .
Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
Kinesio tape is a type of elastic therapeutic tape that was developed which is used in many different situations with various aims. Advocates of Kinesio Tape state that it may promote different therapeutic objectives such as; improved circulation and lymphatic drainage, pain inhibition, reduction of delayed onset of muscle soreness or improvement in performance and coordination .
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Intervention Description
Participants in this group received 4 weeks of manual therapy and massage of the masticatory muscles intra and extra orally together with massage of the cervical muscles. Massage and Manual Therapy brings about benefits by increasing local circulation and decreasing muscle tonus . Additionally, stretching exercises aiming to decrease pain and elongate shortened masticatory muscle fibers by autogenic inhibition of the masseter muscle were performed.
Intervention Type
Procedure
Intervention Name(s)
Kinesio Taping
Intervention Description
Participants in this group had an application of Kinesio Taping on the masseter muscles. The material used for bruxism Kinesio Taping application was Kinesio Tex Gold Finger Prints (Kinesio Holding Corporation, Albuquerque, USA), a 100% cotton, latex-free, 5-cm wide, elastic tape. Kinesio Taping placement was chosen according to principles described by Kase et al. Tapes were cut 2.5 cm in width (cut in half vertically from 5 cm width). Two strips of Kinesio Tape were crossed over the masseter muscle area with 0-5% tension in maximum stretched epidermis position. Web-cut strips epidermis-dermis-fascia technique were used. Tape was applied bilaterally after every session of manual therapy.
Primary Outcome Measure Information:
Title
Pain Pressure Threshold of Masseter Muscle
Description
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the masseter muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Time Frame
Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
Title
Pain Pressure Threshold of Trapezius Muscle
Description
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the trapezius muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Time Frame
Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
Title
Pain Pressure Threshold of Temporalis Muscle
Description
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the temporalis muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Time Frame
Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
The Pittsburgh Sleep Quality Index is an index widely used to measure sleep quality. The Pittsburgh Sleep Quality Index is a self-reported questionnaire that includes 19 questions that when scored, are separated into seven domains. The seven domains are; perceived sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications; and daytime dysfunction. Each domain is scored from 0-3 and a total score ranging from 0-21 can be obtained. A total score of; 0-4 indicates a good sleep quality, 5-10 indicates poor sleep quality and scores above 10 indicate a possible sleep disorder.
Time Frame
Change from Baseline Sleep Quality at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders Self-report of awake bruxism Exclusion Criteria: Having more than 2 missing teeth The presence of removable partial dentures Having neurological, psychiatric or motor disorders Having any ongoing dental or physical therapy Active cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Yazici, PhD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06650
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be available to other researchers

Learn more about this trial

Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism

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