Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-10-15

Brief Summary

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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

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Detailed Description

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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

Conditions

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Myalgia Trigger Point

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pulse mode

Pulsed 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

Group Type EXPERIMENTAL

therapeutic ultrasound

Intervention Type DEVICE

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.

Continous mode

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.

Group Type ACTIVE_COMPARATOR

therapeutic ultrasound

Intervention Type DEVICE

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.

Interventions

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therapeutic ultrasound

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes