A Retrospective Randomized Controlled Study Comparing the Effectiveness of Low-level Laser Therapy and Ultrasound Therapy in Reducing Pain and Increasing Maximum Mouth Opening in Forty-six Patients With Temporomandibular Disorders

NCT07378462 | Completed DMC

• 1 other identifier: IRC/2509/023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorders (TMDs) are the most common cause of non-dental orofacial pain, involving the temporomandibular joint (TMJ), masticatory muscles, or associated structures. Globally, TMD is the second most prevalent musculoskeletal pain condition after low back pain. Epidemiological data show a high prevalence of TMD symptoms, particularly among women and Asian populations, with significant disease burden reported in Nepal. Conservative management remains the mainstay of TMD treatment, as evidence supporting surgical intervention is limited and inconclusive. Among conservative modalities, physical therapies such as ultrasound therapy and low-level laser therapy (LLLT) have gained attention for pain reduction and functional improvement. Ultrasound therapy produces thermal and non-thermal effects that enhance blood flow, reduce muscle spasm, improve tissue extensibility, and promote healing. LLLT, through photobiomodulation, acts at the cellular level by increasing ATP production, reducing inflammatory mediators, enhancing collagen synthesis, and providing analgesic and anti-inflammatory effects. Although several international studies have evaluated ultrasound and LLLT individually or in combination, limited studies have directly compared their effectiveness in TMD, and no such studies have been conducted in Nepal. Therefore, this study aims to compare the effectiveness of therapeutic ultrasound and LLLT in reducing pain and improving mouth opening in patients with TMD presenting to BPKIHS. This was a retrospective randomized controlled study conducted at the Department of Oral Medicine and Radiology, College of Dental Surgery, BPKIHS. A total of 46 patients diagnosed with myalgia of masticatory muscles and/or TMJ arthralgia according to DC/TMD criteria were included using purposive sampling. Patients were allocated into two groups: Group A received low-level laser therapy (650 nm wavelength, 2 J/cm² for 3 minutes) and Group B received therapeutic ultrasound (1 MHz, 1.3 W/cm², continuous mode for 5 minutes). Five treatment sessions had been administered over two weeks. Pain intensity was assessed using the Visual Analogue Scale (VAS) at each visit, while inter-incisal mouth opening was measured using a metallic scale at baseline and at the final visit. Primary outcome measure was the difference in VAS scores in patients undergoing ultrasound therapy and low-level laser therapy for temporomandibular disorder before and after therapy. Secondary outcome measures included the difference in inter-incisal mouth opening before and after therapy and the effectiveness of ultrasound therapy and low-level laser therapy in reducing pain in patients with arthralgia and myalgia. Data were analyzed using SPSS version 11.5. Descriptive statistics were calculated, and inferential tests including independent and paired t-tests (or non-parametric equivalents), ANOVA/Kruskal-Wallis tests, and logistic regression were applied where appropriate. Ethical clearance was obtained from the Institutional Review Committee, BPKIHS with Ref. 20/080/081-IRC, Code no. IRC/2509/023.

Conditions

Temporomandibular Disorders (TMD); Temporomandibular Joint Disorder

Keywords

low-level laser therapy; Temporomandibular Disorder (TMD); ultrasound therapy

Outcome Measures

Primary Outcomes (1)

• Compare the difference in mean pain intensity scores in patients undergoing Low-Level Laser Therapy and Ultrasound Therapy for Temporomandibular Disorder before and after therapy.

  Description: Pain intensity was assessed using the Visual Analogue Scale (VAS). The VAS consisted of a 10-cm horizontal line, with the left end representing "no pain" (0) and the right end representing "worst imaginable pain" (10). Higher scores indicated greater pain intensity. Participants were instructed on the use of the scale and were asked to mark a single point on the line corresponding to their current level of temporomandibular joint pain. Pain scores were recorded at baseline (pre-therapy) and at subsequent visits during the treatment period. The change in pain intensity was calculated by comparing pre- and post-therapy scores and was expressed as percentage reduction in VAS score.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

• Compare the difference in mean inter-incisal mouth opening in patients undergoing Low-Level Laser Therapy and Ultrasound Therapy for Temporomandibular Disorder pre- and post-therapy

  From enrollment to the end of treatment at 2 weeks

• Compare the effectiveness of Low-Level Laser Therapy and Ultrasound Therapy in reducing pain in patients with temporomandibular joint arthralgia and myalgia of the masseter and temporalis muscles.

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Low-level laser therapy

EXPERIMENTAL

Participants in this arm received low-level laser therapy applied to the area of maximum pain in the temporomandibular region. The therapy was delivered using a single-probe laser emitting infrared radiation at a wavelength of 650 nm, with an energy density of 2 J/cm² and an output power of 80 mW for 3 minutes per session. Treatment was administered over five sessions.

Device: Low-Level Laser Therapy

Ultrasound therapy

EXPERIMENTAL

Participants in this arm received therapeutic ultrasound applied to the affected temporomandibular region. Ultrasound was delivered at a frequency of 1 MHz and an intensity of 1.3 W/cm² in continuous mode for 5 minutes per side per session. Treatment was administered over five sessions.

Device: Ultrasound therapy

Interventions

Low-Level Laser Therapy DEVICE

Low-level laser therapy delivered using a single-probe laser emitting infrared radiation at 650 nm, with an energy density of 2 J/cm² and output power of 80 mW for 3 minutes per session, applied to the area of maximum pain.

Also known as: Light Therapy, Low-Level, Photobiomodulation Therapy

Low-level laser therapy

Ultrasound therapy DEVICE

Therapeutic ultrasound delivered at a frequency of 1 MHz and intensity of 1.3 W/cm² in continuous mode for 5 minutes per side per session, applied to the affected temporomandibular region.

Also known as: Therapeutic ultrasound

Ultrasound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient diagnosed with myalgia of masseter and temporalis muscles and arthralgia of TMJ based on Diagnostic Criteria for Temporomandibular Disorders DC/TMD.

You may not qualify if:

• Patients who were not willing to participate in the research.
• Patients who were undergoing treatment or had already undergone treatment for temporomandibular disorders within the preceding three months.
• Patients who were taking antidepressants, analgesics, or antipsychotic medications.
• Patients who had structural bony abnormalities of the temporomandibular joint on radiographic examination.
• Patients with the presence of joint disorders.
• Pregnant women.
• Patients with a history of facial trauma or fractures of the facial bones.
• Patients who presented with severe pain.
• Patients with severely reduced mouth opening (i.e., less than 10 mm).

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B.P. Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

Location

Related Publications (27)

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MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Diathermy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Model Details: An interventional, comparative, parallel-group clinical study conducted in patients diagnosed with temporomandibular disorders according to DC/TMD criteria. Participants were allocated into two groups to receive either Low-Level Laser Therapy or Therapeutic Ultrasound Therapy, and outcomes were assessed over five treatment sessions.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 30, 2026
• Study Start: July 21, 2023
• Primary Completion: May 17, 2024
• Study Completion: November 20, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All the data are collected and will be provided when and where required.

Locations

NE (1)