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

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363931
• Other study ID #: GaziU2020
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: April 4, 2020

Study information

• Verified date: April 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 4, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism

Intervention

Procedure:
• Manual Therapy
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.
• Kinesio Taping
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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Change from Baseline Sleep Quality at 4 weeks