Clinical trial NCT05211245: Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region
Official title: Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myalgia
Trigger Point
Keywords: Therapeutic ultrasound
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Pain and trismus caused by Myalgia in masticatory muscles are one of the prime concerns for the patients. There are limited number of studies in the literature that have evaluated therapeutic ultrasound for the management of Myalgia of maxillofacial region. Various studies have been performed, evaluating the treatment of myofascial pain with trigger point in other parts of body including neck region using ultrasound, but not all patient of myalgia present with trigger point. The most frequently used ultrasound frequencies are 1 and 3MHz. 1 MHz has more penetrating power as compared to 3MHz. Masticatory muscles being superficial in location need less penetrating waves as compared to other muscles. The ultrasound can be applied in a continuous or pulsed manner. There are studies supporting the fact that Continuous ultrasound therapy is more efficient in reducing myofascial pain syndrome of trapezius muscle at rest because it produces a heating effect in the muscles, that help in breaking the spasm. On the other hand, the pulsed mode, produces more of penetrating effect and acts on the gas bubbles of the soft tissues, thereby decreasing the inflammation. However, the two methods have not yet been compared in maxillofacial muscles. Therefore, this study aims to compare the outcome of therapeutic Ultrasound administered at 3MHz frequency in continuous \& pulse modes in myalgia of maxillofacial region

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib)
2. Patient's consent for participation in this study.

Exclusion Criteria:

1. Patients with epilepsy/seizures
2. Patients with radiographic changes suggestive of pathological conditions of temporomandibular joint (TMJ).
3. Patients with undiagnosed orofacial pain
4. Any sort of skin lesion at the site where electrode is to be placed.
5. Therapeutic ultrasound must not be applied over areas of impaired circulation, ischemic areas, or areas having sensory deficit.
6. Sites of active infection
7. Patients with metal prosthesis
8. Patients with Becks depression score \>25 will be excluded.

Primary outcomes:
measure: To evaluate the intensity of pain in each group
timeFrame: Base line
measure: To evaluate the intensity of pain in each group
timeFrame: 2 weeks
measure: To evaluate the intensity of pain in each group
timeFrame: 4weeks
measure: To evaluate the intensity of pain in each group
timeFrame: 6 weeks
measure: To evaluate the intensity of pain in each group
timeFrame: 3 months
measure: To assess pressure pain sensitivity of muscles in the two groups.
timeFrame: Base line
measure: To assess pressure pain sensitivity of muscles in the two groups.
timeFrame: 2 weeks
measure: To assess pressure pain sensitivity of muscles in the two groups.
timeFrame: 4 weeks
measure: To assess pressure pain sensitivity of muscles in the two groups.
timeFrame: 6 weeks
measure: To assess pressure pain sensitivity of muscles in the two groups.
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the maximal mouth opening and functional movements
timeFrame: Base line
measure: To evaluate the maximal mouth opening and functional movements
timeFrame: 2 weeks
measure: To evaluate the maximal mouth opening and functional movements
timeFrame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
measure: To evaluate patient psychological status
timeFrame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
measure: To evaluate quality of life
timeFrame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
measure: To assess the need for pain medication
timeFrame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: oral medicine & radiology,PGIDS
name: Dr. Ambika Gupta, MDS
role: STUDY_DIRECTOR
References: