Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region
1 other identifier
interventional
80
1 country
1
Brief Summary
Pain and trismus caused by Myalgia in masticatory muscles are one of the prime concerns for the patients. Various studies have been performed using US therapy for myofascial pain syndrome of head \& neck region. US is a non-invasive frequently used physical agent which increase blood flow in tissues and collagen fibers ability to grow, \& reduce muscle spasm with its thermal effect. It is difficult to imply the results of studies performed in muscles of other regions of body to the maxillofacial region because of the superficial placement of these muscles.US is being frequently used for myofascial pain, but there is an absence of a consensus regarding the frequency and mode of administration available in literature for administration of this therapy in maxillofacial region. Therefore, the present study has been designed to compare the therapeutic effect of two modes of US i.e., continuous and pulsed at 3 MHz frequency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
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
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedMarch 14, 2023
March 1, 2023
1.2 years
August 12, 2021
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Base line
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
2 weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
4weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
6 weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
3 months
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Base line
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
2 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
4 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
6 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
3 months
Secondary Outcomes (6)
To evaluate the maximal mouth opening and functional movements
Base line
To evaluate the maximal mouth opening and functional movements
2 weeks
To evaluate the maximal mouth opening and functional movements
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate patient psychological status
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate quality of life
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
- +1 more secondary outcomes
Study Arms (2)
Pulse mode
EXPERIMENTALPulsed mode of US results in nonthermal effect i.e., micro massage like which lead to segmental analgesia due to decreased central \& peripheral sensitization. The non-thermal effect of US can be explain by frequency resonance theory which states that the proteins in these structures absorbs mechanical energy thus altering the structure \& function, finally resulting in stimulation of phagocytosis, increase number of free radicals, increase cell membrane permeability, cellular proliferation \&acceleration of fibrinolysis
Continous mode
ACTIVE COMPARATORThermal effect which is a result of continuous mode of US therapy causes transient increase in the flexibility of collagenous structures including ligaments, tendons \& joint capsules, thus leading to decrease in the pain \& muscle spasm, stiffness of the joint \& temporary increase in the blood flow.
Interventions
Therapeutic ultrasound ranges from 750,000 to 3,300,000 Hz (0.75 to 3.3 MHz). Depending upon the output parameters it may produce effects like increase tissue extensibility, reduction of calcium deposits, reduction of pain \& muscle spasm by altering nerve conduction velocity \& changes in cell membrane permeability along with increased rate of tissue repair \& wound healing.There are two main types of ultrasound therapy: thermal and mechanical. Thermal effect which is a result of continuous mode of US therapy causes transient increase in the flexibility of collagenous structures including ligaments, tendons \& joint capsules, thus leading to decrease in the pain \& muscle spasm, stiffness of the joint \& temporary increase in the blood flow. Pulsed mode of US results in nonthermal effect i.e., micro massage like which lead to segmental analgesia due to decreased central \& peripheral sensitization.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib)
- Patient's consent for participation in this study.
You may not qualify if:
- Patients with epilepsy/seizures
- Patients with radiographic changes suggestive of pathological conditions of temporomandibular joint (TMJ).
- Patients with undiagnosed orofacial pain
- Any sort of skin lesion at the site where electrode is to be placed.
- Therapeutic ultrasound must not be applied over areas of impaired circulation, ischemic areas, or areas having sensory deficit.
- Sites of active infection
- Patients with metal prosthesis
- Patients with Becks depression score \>25 will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIDS
Rohtak, Haryana, 124001, India
Related Publications (1)
Saini B, Gupta A, Singh H, Bisla S, Nagarajan S, Kumia K. Effectiveness of continuous and pulse mode of ultrasound therapy in temporomandibular disorders associated myalgia-a randomized controlled study. J Oral Facial Pain Headache. 2025 Mar;39(1):81-92. doi: 10.22514/jofph.2025.007. Epub 2025 Mar 12.
PMID: 40129425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Ambika Gupta, MDS
oral medicine & radiology,PGIDS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2021
First Posted
January 27, 2022
Study Start
August 1, 2021
Primary Completion
October 15, 2022
Study Completion
October 15, 2022
Last Updated
March 14, 2023
Record last verified: 2023-03