Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
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 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2020
CompletedFirst Submitted
Initial submission to the registry
April 23, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedApril 27, 2020
April 1, 2020
5 months
April 23, 2020
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
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.
Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
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.
Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks
Secondary Outcomes (1)
Sleep Quality
Change from Baseline Sleep Quality at 4 weeks
Study Arms (2)
Manual Therapy
EXPERIMENTALManual 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 Taping
EXPERIMENTALKinesio 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 .
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders
- Self-report of awake bruxism
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi University
Ankara, Çankaya, 06650, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gokhan Yazici, PhD
Gazi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2020
First Posted
April 27, 2020
Study Start
October 7, 2019
Primary Completion
February 28, 2020
Study Completion
April 4, 2020
Last Updated
April 27, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be available to other researchers