The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.

August 19, 2021 updated by: Dalewski Bartosz, Pomeranian Medical University Szczecin

The Effect of Different Physiotherapeutic Stimuli on Mandibular Analgesia and Range of Motion in Patients With Masticatory Muscles Disorder.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Szczecin, Poland
        • Department of Musculoskeletal System Rehabilitation, Pomeraniam Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiotherapeutic procedures: magnetotherapy
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.
Other: Four different physiotherapy treatment
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.
Active Comparator: Physiotherapeutic procedures:magneto-led therapy
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.
Other: Four different physiotherapy treatment
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.
Active Comparator: Physiotherapeutic procedures:magneto-laser therapy
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.
Other: Four different physiotherapy treatment
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.
Active Comparator: Physiotherapeutic procedures: manual therapy of soft tissues
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.
Other: Four different physiotherapy treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 10 days
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]
10 days
Measurement of the range of motion
Time Frame: 10 days

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]
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 25, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB - 0012/102/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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