MyalgiaNCT05211245
Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region
A study testing therapeutic ultrasound in people with Myalgia and Trigger Point, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myalgia, Trigger Point
- What is being tested?
- therapeutic ultrasound
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib)
- Patient's consent for participation in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Myalgia, Trigger Point
- Being tested
- therapeutic ultrasound
- Keywords
- Therapeutic ultrasound
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulse mode | Experimental | 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 Receives: Device: therapeutic ultrasound |
| Continous mode | Active comparator | 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. Receives: Device: therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Measured: Base line
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Measured: 2 weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Measured: 4weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Measured: 6 weeks
To evaluate the intensity of pain in each group
Visual Analog Scale (VAS) 0n a scale of 0-10
Measured: 3 months
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Measured: Base line
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Measured: 2 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Measured: 4 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Measured: 6 weeks
To assess pressure pain sensitivity of muscles in the two groups.
Algometer
Measured: 3 months
Secondary outcomes (6)
To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
Measured: Base line
To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
Measured: 2 weeks
To evaluate the maximal mouth opening and functional movements
Digital Vernier calliper
Measured: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate patient psychological status
Beck depression inventory
Measured: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To evaluate quality of life
Oral Health Impact Profile (OHIP 14)
Measured: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
To assess the need for pain medication
number of medication needed
Measured: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Aug 2021
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyalgiaStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Ambika Gupta, MDS, Study director, oral medicine & radiology,PGIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211245
- Sponsor's protocol ID
- Dr.Bhawna Saini
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saini B, Gupta A, Singh H, Bisla S, Nagarajan S, Kumia K. Effectiveness of continuous and pulse mode of ultrasound therapy in temporomandibular disorders associated myalgia-a randomized controlled study. J Oral Facial Pain Headache. 2025 Mar;39(1):81-92. doi: 10.22514/jofph.2025.007. Epub 2025 Mar 12.
PubMed 40129425
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region
- ClinicalTrials.gov ID
- NCT05211245
- Acronym / sponsor ID
- Dr.Bhawna Saini
- Conditions
- Myalgia, Trigger Point
- Keywords
- Therapeutic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulse mode | Experimental | Device: therapeutic ultrasoundPulsed 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 |
| Continous mode | Active comparator | Device: therapeutic ultrasoundThermal 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib)
- Patient's consent for participation in this study.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic ultrasoundTherapeutic 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. | Device | Continous mode, Pulse mode |
Primary outcome
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
6 secondary outcomes
To evaluate the maximal mouth opening and functional movements
Time frame: Base line
To evaluate the maximal mouth opening and functional movements
Time frame: 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
To evaluate patient psychological status
Time frame: 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
To assess the need for pain medication
Time frame: Base line ,2 weeks,4 weeks ,6 weeks, 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 40129425Saini B, Gupta A, Singh H, Bisla S, Nagarajan S, Kumia K. Effectiveness of continuous and pulse mode of ultrasound therapy in temporomandibular disorders associated myalgia-a randomized controlled study. J Oral Facial Pain Headache. 2025 Mar;39(1):81-92. doi: 10.22514/jofph.2025.007. Epub 2025 Mar 12.
Related trials for Myalgia
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Estrogen Receptor-Positive Breast Carcinoma
Recruiting
Shower Gel and Participant-Reported Post-Exercise Soreness in Regular Exercisers
Post-Exercise Recovery, Muscle Soreness
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ambika Gupta, MDS study director
oral medicine & radiology,PGIDS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic ultrasound in people with Myalgia and Trigger Point, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the intensity of pain in each group (time frame: Base line). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.