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

Overview

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 Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: October 15, 2022

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

Interventions

• 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.

Arms, Groups and Cohorts

• 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
• 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.

Clinical Trial Outcome Measures

Primary Measures

• To evaluate the intensity of pain in each group
  • Time Frame: Base line
  • Visual Analog Scale (VAS) 0n a scale of 0-10
• To evaluate the intensity of pain in each group
  • Time Frame: 2 weeks
  • Visual Analog Scale (VAS) 0n a scale of 0-10
• To evaluate the intensity of pain in each group
  • Time Frame: 4weeks
  • Visual Analog Scale (VAS) 0n a scale of 0-10
• To evaluate the intensity of pain in each group
  • Time Frame: 6 weeks
  • Visual Analog Scale (VAS) 0n a scale of 0-10
• To evaluate the intensity of pain in each group
  • Time Frame: 3 months
  • Visual Analog Scale (VAS) 0n a scale of 0-10
• To assess pressure pain sensitivity of muscles in the two groups.
  • Time Frame: Base line
  • Algometer
• To assess pressure pain sensitivity of muscles in the two groups.
  • Time Frame: 2 weeks
  • Algometer
• To assess pressure pain sensitivity of muscles in the two groups.
  • Time Frame: 4 weeks
  • Algometer
• To assess pressure pain sensitivity of muscles in the two groups.
  • Time Frame: 6 weeks
  • Algometer
• To assess pressure pain sensitivity of muscles in the two groups.
  • Time Frame: 3 months
  • Algometer

Secondary Measures

• To evaluate the maximal mouth opening and functional movements
  • Time Frame: Base line
  • Digital Vernier calliper
• To evaluate the maximal mouth opening and functional movements
  • Time Frame: 2 weeks
  • Digital Vernier calliper
• 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
• To evaluate patient psychological status
  • Time Frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
  • Beck depression inventory
• 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)
• 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Postgraduate Institute of Dental Sciences Rohtak
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Dr. Ambika Gupta, MDS, Study Director, oral medicine & radiology,PGIDS