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

Primary Purpose

Myalgia, Trigger Point

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
therapeutic ultrasound
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myalgia focused on measuring Therapeutic ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PGIDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulse mode

Continous mode

Arm Description

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

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.

Outcomes

Primary Outcome Measures

To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
To assess pressure pain sensitivity of muscles in the two groups.
Algometer

Secondary Outcome Measures

To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
To evaluate patient psychological status
Beck depression inventory
To evaluate quality of life
Oral Health Impact Profile (OHIP 14)
To assess the need for pain medication
number of medication needed

Full Information

First Posted
August 12, 2021
Last Updated
March 13, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05211245
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgia, Trigger Point
Keywords
Therapeutic ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse mode
Arm Type
Experimental
Arm Description
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
Arm Title
Continous mode
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
therapeutic ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the intensity of pain in each group
Description
Visual Analog Scale (VAS) 0n a scale of 0-10
Time Frame
Base line
Title
To evaluate the intensity of pain in each group
Description
Visual Analog Scale (VAS) 0n a scale of 0-10
Time Frame
2 weeks
Title
To evaluate the intensity of pain in each group
Description
Visual Analog Scale (VAS) 0n a scale of 0-10
Time Frame
4weeks
Title
To evaluate the intensity of pain in each group
Description
Visual Analog Scale (VAS) 0n a scale of 0-10
Time Frame
6 weeks
Title
To evaluate the intensity of pain in each group
Description
Visual Analog Scale (VAS) 0n a scale of 0-10
Time Frame
3 months
Title
To assess pressure pain sensitivity of muscles in the two groups.
Description
Algometer
Time Frame
Base line
Title
To assess pressure pain sensitivity of muscles in the two groups.
Description
Algometer
Time Frame
2 weeks
Title
To assess pressure pain sensitivity of muscles in the two groups.
Description
Algometer
Time Frame
4 weeks
Title
To assess pressure pain sensitivity of muscles in the two groups.
Description
Algometer
Time Frame
6 weeks
Title
To assess pressure pain sensitivity of muscles in the two groups.
Description
Algometer
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To evaluate the maximal mouth opening and functional movements
Description
Digital Vernier calliper
Time Frame
Base line
Title
To evaluate the maximal mouth opening and functional movements
Description
Digital Vernier calliper
Time Frame
2 weeks
Title
To evaluate the maximal mouth opening and functional movements
Description
Digital Vernier calliper
Time Frame
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Title
To evaluate patient psychological status
Description
Beck depression inventory
Time Frame
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Title
To evaluate quality of life
Description
Oral Health Impact Profile (OHIP 14)
Time Frame
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Title
To assess the need for pain medication
Description
number of medication needed
Time Frame
Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib) Patient's consent for participation in this study. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ambika Gupta, MDS
Organizational Affiliation
oral medicine & radiology,PGIDS
Official's Role
Study Director
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

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

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