The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.

Sponsor

Pomeranian Medical University Szczecin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05021874

Collaborator

(none)

100

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

51.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Stomatognathic Diseases Muscle Hypertonia Myofacial Pain Syndromes Analgesia Musculoskeletal Pain Craniomandibular Osteopathy Temporomandibular Disorder	Other: Four different physiotherapy treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 25, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Pain relief [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]
Measurement of the range of motion [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Past or present, neurological disease, neuromuscular disease or a severe systemic disease.
Temporomandibular joint pathology based on X-ray imaging or stomatological examination.
Orthodontic or prosthetic treatment IV. Contraindication to physiotherapeutic treatment