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The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.

Primary Purpose

Pain, Stomatognathic Diseases, Muscle Hypertonia

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Four different physiotherapy treatment
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring Pain, Physiotherapy, Range of motion, Temporomandibular Joint, Stomatognathic system

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

I. Myofacial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation.

II. Diagnosis according to RDC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which showed painful myofascial disorders III. A feeling of an increased muscle tension IV. Presence of all occlusal contact zones V. Female sex

Exclusion Criteria:

I. Past or present, neurological disease, neuromuscular disease or a severe systemic disease.

II. Temporomandibular joint pathology based on X-ray imaging or stomatological examination.

III. Orthodontic or prosthetic treatment IV. Contraindication to physiotherapeutic treatment

Sites / Locations

  • Department of Musculoskeletal System Rehabilitation, Pomeraniam Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Physiotherapeutic procedures: magnetotherapy

Physiotherapeutic procedures:magneto-led therapy

Physiotherapeutic procedures:magneto-laser therapy

Physiotherapeutic procedures: manual therapy of soft tissues

Arm Description

Magnetotherapy is a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) will be applied using an elliptical applicator with a beam width of approx. 5 cm. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.

Magneto-led therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and LED diodes with the wavelength of 860 nm were applied using an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.

Magneto-laser therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and a low-energy laser with infrared wavelength of 808 [nm] (max. power 300 mW) was applied. The dose was set to increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.

Manual therapy of soft tissues will include: post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.

Outcomes

Primary Outcome Measures

Pain relief
Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain" [Time Frame: 10 days]
Measurement of the range of motion
Measurement of the range of mobility of the maximum abduction of the mandible (linear measurement from in mm. the upper to the lower incisor). [Time Frame: 10 days]

Secondary Outcome Measures

Full Information

First Posted
August 19, 2021
Last Updated
August 19, 2021
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT05021874
Brief Title
The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.
Official Title
The Effect of Different Physiotherapeutic Stimuli on Mandibular Analgesia and Range of Motion in Patients With Masticatory Muscles Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 25, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

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
The study will determinate influence of four selected physiotherapeutic procedures on the pain intensity and the range of mandibular mobility in patients with myofascial disorders in the SS.
Detailed Description
The study group will consist of 100 women (GI) aged 20 to 45 who report pain and increased facial muscle tension in masseter muscles. The diagnosis will be made according to RDC/TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which will determine the occurrence of painful myofascial disorders. Patients will undergo both external and intraoral dental examinations to exclude odontogenic and articular causes of pain. Patients will then be palpated for the masseter muscles and both: the range of mandibular abduction (linear measurement in mm) and the level of pain intensity (VAS scale). The control group (GII) will consist of 100 women between 20 and 45 years of age with no signs of masticatory disorders or orofacial pain during a physical examination and with no such reference in their medical records. In order to obtain a homogenic study group the following inclusion criteria will be applied: Myofascial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation. A feeling of an increased muscle tension Presence of all occlusal contact zones Female sex Exclusion criteria: Past or present, neurological disease, neuromuscular disease or severe systemic disease. Temporomandibular joint pathology based on X-ray imaging or stomatological examination. Orthodontic or prosthetic treatment Contraindication to physiotherapeutic treatment Patients with a stomatognathic system disorder will be randomized into four therapeutic subgroups, 26 patients each, who will receive a physiotherapy treatment of the masseter muscles for a period of 10 days (excluding Saturdays and Sundays). The duration of a single therapy session will be 12 minutes per patient in each of the subgroups. The division of the study group into subgroups is as follows: IA: magnetotherapy; a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) will be applied with an elliptical applicator with a beamwidth of approx. 5 cm. IB: magneto-led therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and LED diodes with the wavelength of 860 nm will be applied with an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes. IC: magneto-laser therapy; synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and a low-energy laser with an infrared wavelength of 808 [nm] (max. power 300 mW) will be applied. The dose would increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2. ID: manual therapy of soft tissues (i.e. post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy). Immediately after the therapy, the patients' pain level will be assessed via VAS scale. After the last day of physiotherapy, a linear measurement of mandibular abduction will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Stomatognathic Diseases, Muscle Hypertonia, Myofacial Pain Syndromes, Analgesia, Musculoskeletal Pain, Craniomandibular Osteopathy, Temporomandibular Disorder
Keywords
Pain, Physiotherapy, Range of motion, Temporomandibular Joint, Stomatognathic system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapeutic procedures: magnetotherapy
Arm Type
Active Comparator
Arm Description
Magnetotherapy is a pulsating, non-homogeneous magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) will be applied using an elliptical applicator with a beam width of approx. 5 cm. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.
Arm Title
Physiotherapeutic procedures:magneto-led therapy
Arm Type
Active Comparator
Arm Description
Magneto-led therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and LED diodes with the wavelength of 860 nm were applied using an elliptic magnetic-light (IR) applicator with a diameter of 5 [cm] containing 47 infrared diodes. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.
Arm Title
Physiotherapeutic procedures:magneto-laser therapy
Arm Type
Active Comparator
Arm Description
Magneto-laser therapy is a synergistic action of a slowly changing magnetic field generated by the Viofor JPS apparatus (Med & Life, Poland) and a low-energy laser with infrared wavelength of 808 [nm] (max. power 300 mW) was applied. The dose was set to increase from 3,0 J/cm2 to 5,0 J/cm2 and the total dose applied per each patient from this subgroup was 40 J/cm2. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.
Arm Title
Physiotherapeutic procedures: manual therapy of soft tissues
Arm Type
Active Comparator
Arm Description
Manual therapy of soft tissues will include: post-isometric relaxation of the masseter, cellular and tissue mobilization with Kibler fold, masseter trigger point therapy. Formative procedures within the masseter muscle, duration of the session amounted to 12 minutes. Physiotherapy treatment of the masseter muscles for a period of 10 days.
Intervention Type
Other
Intervention Name(s)
Four different physiotherapy treatment
Intervention Description
Four different physiotherapy treatment will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 10th day of therapy, it will be measured ROM.
Primary Outcome Measure Information:
Title
Pain relief
Description
Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain" [Time Frame: 10 days]
Time Frame
10 days
Title
Measurement of the range of motion
Description
Measurement of the range of mobility of the maximum abduction of the mandible (linear measurement from in mm. the upper to the lower incisor). [Time Frame: 10 days]
Time Frame
10 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Famale
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: I. Myofacial pain of less than 12 months in duration that is evoked by an active motion of the mandible or by palpation. II. Diagnosis according to RDC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders), which showed painful myofascial disorders III. A feeling of an increased muscle tension IV. Presence of all occlusal contact zones V. Female sex Exclusion Criteria: I. Past or present, neurological disease, neuromuscular disease or a severe systemic disease. II. Temporomandibular joint pathology based on X-ray imaging or stomatological examination. III. Orthodontic or prosthetic treatment IV. Contraindication to physiotherapeutic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Gębska, PhD
Phone
91 441 72 53
Ext
+48
Email
mgebska@pum.edu.pl
Facility Information:
Facility Name
Department of Musculoskeletal System Rehabilitation, Pomeraniam Medical University
City
Szczecin
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.

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