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

March 13, 2023 updated by: Postgraduate Institute of Dental Sciences Rohtak
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the intensity of pain in each group
Time Frame: Base line
Visual Analog Scale (VAS) 0n a scale of 0-10
Base line
To evaluate the intensity of pain in each group
Time Frame: 2 weeks
Visual Analog Scale (VAS) 0n a scale of 0-10
2 weeks
To evaluate the intensity of pain in each group
Time Frame: 4weeks
Visual Analog Scale (VAS) 0n a scale of 0-10
4weeks
To evaluate the intensity of pain in each group
Time Frame: 6 weeks
Visual Analog Scale (VAS) 0n a scale of 0-10
6 weeks
To evaluate the intensity of pain in each group
Time Frame: 3 months
Visual Analog Scale (VAS) 0n a scale of 0-10
3 months
To assess pressure pain sensitivity of muscles in the two groups.
Time Frame: Base line
Algometer
Base line
To assess pressure pain sensitivity of muscles in the two groups.
Time Frame: 2 weeks
Algometer
2 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Time Frame: 4 weeks
Algometer
4 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Time Frame: 6 weeks
Algometer
6 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Time Frame: 3 months
Algometer
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the maximal mouth opening and functional movements
Time Frame: Base line
Digital Vernier calliper
Base line
To evaluate the maximal mouth opening and functional movements
Time Frame: 2 weeks
Digital Vernier calliper
2 weeks
To evaluate the maximal mouth opening and functional movements
Time Frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Digital Vernier calliper
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate patient psychological status
Time Frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Beck depression inventory
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate quality of life
Time Frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
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
Time Frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
number of medication needed
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Dental Sciences Rohtak

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr. Ambika Gupta, MDS, oral medicine & radiology,PGIDS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings