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

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

Study Overview

• Status: Completed
• Conditions: Myalgia; Trigger Point
• Intervention / Treatment: Device: therapeutic ultrasound

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the maximal mouth opening and functional movements	Digital Vernier calliper	Base line
To evaluate the maximal mouth opening and functional movements	Digital Vernier calliper	2 weeks
To evaluate the maximal mouth opening and functional movements	Digital Vernier calliper	Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate patient psychological status	Beck depression inventory	Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate quality of life	Oral Health Impact Profile (OHIP 14)	Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To assess the need for pain medication	number of medication needed	Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Study Director: Dr. Ambika Gupta, MDS, oral medicine & radiology,PGIDS

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Therapeutic ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: Dr.Bhawna Saini

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No