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Comparative effectiveness of various treatment methods of masticatory myofascial pain

Comparative effectiveness of ultrasound therapy, stabilization splint, and TheraBite device for the treatment of masticatory myofascial pain: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20833186
Enrollment
40
Registered
2023-11-10
Start date
2023-05-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial pain syndrome Musculoskeletal Diseases

Interventions

Randomization will be performed using a simple randomization method in a ratio of 1:1:1:1, by means of an online randomization software https://www.randomizer.org/. The number of sets generated is 4,

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient with myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). 2. Visual Analogue Scale (VAS) score = 4, with pain lasting for at least 6 months. 3. Patients aged 18 years old and over

Exclusion criteria

Exclusion criteria: 1. Fixed or removable prosthesis 2. Systemic diseases 3. Analgesics and/or muscle relaxants over the past 24 hours 4. Already undergone MPS treatment 5. Polyarthritis, osteoarthritis or arthralgia

Design outcomes

Primary

MeasureTime frame
The following primary outcome measures will be assessed at baseline (t0), at the 1st (t1), 2nd (t2), and 4th (t3) week of treatment, and at the 3rd (t4) and 6th (t5) month of follow-up: 1. Pain intensity measured using a visual analog scale (VAS). Each patient is asked to record their current level of pain by marking a point on the VAS line that represents their pain intensity. Grading of pain according to the VAS score is as follows: 0-3 = Mild pain 3-8 = Moderate pain 8-10 = Severe pain Active range of motion 2. Active range of motion (AROM) when the patient has their mouth open to the maximum comfortable range, measured using the distance from the incisal edge of the right maxillary central incisor to the incisal edge of the right mandibular central incisor in millimeters (mm) 3. Right lateral movement (RLM) when the patient moves their mandible to the right at the maximum comfortable extent, measured using the horizontal distance between the maxillary midline to the mandibular midline in mm 4. Left lateral movement (LLM) when the patient slides their mandible to the left to the maximum comfortable extent measured using the horizontal distance between the maxillary midline to the mandibular midline in mm

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Syria

Contacts

Public ContactMawia;Mawia Karkoutly;Karkoutly

;

mawia95.karkoutly@damascusuniversity.edu.sy;Mawiamaherkarkoutly@hotmail.com+963 (11) 33923223;+963992647528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026