The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Sep 2021
Shorter than P25 for not_applicable pain
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
First Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedAugust 26, 2021
August 1, 2021
24 days
August 19, 2021
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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" \[Time Frame: 10 days\]
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). \[Time Frame: 10 days\]
10 days
Study Arms (4)
Physiotherapeutic procedures: magnetotherapy
ACTIVE COMPARATORMagnetotherapy 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.
Physiotherapeutic procedures:magneto-led therapy
ACTIVE COMPARATORMagneto-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.
Physiotherapeutic procedures:magneto-laser therapy
ACTIVE COMPARATORMagneto-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.
Physiotherapeutic procedures: manual therapy of soft tissues
ACTIVE COMPARATORManual 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Musculoskeletal System Rehabilitation, Pomeraniam Medical University
Szczecin, Poland
Related Publications (1)
Gebska M, Dalewski B, Palka L, Kiczmer P, Kolodziej L. Kinesio Taping as an alternative therapy for limited mandibular mobility with pain in female patients with temporomandibular disorders: A randomized controlled trial. Dent Med Probl. 2024 Sep-Oct;61(5):659-670. doi: 10.17219/dmp/173126.
PMID: 38832764DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMD,PD
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 26, 2021
Study Start
September 1, 2021
Primary Completion
September 25, 2021
Study Completion
October 30, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share