NCT03287531

Brief Summary

This study was to determine the effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction. sixty patients with myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients in each group; Group I received traditional exercise. Group II received low level laser therapy in addition to traditional exercise. All outcome measures including Pain and function, were evaluated before and after the treatment program.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

September 16, 2017

Last Update Submit

September 18, 2017

Conditions

Keywords

conventional therapy

Outcome Measures

Primary Outcomes (1)

  • Pain algometry

    4 weeks

Secondary Outcomes (1)

  • Jaw Functional questionnaire

    4 weeks

Study Arms (2)

conventional therapy (group I)

EXPERIMENTAL

1. Exercise therapy. For muscles around TMJ : Masetter Lateral Pterygoid Medial Pterygoid Temporalis Digastric 2. Pulsed ultrasound at 0.3 to 0.6 watts per sq cm over the lateral poles of the temporomandibular joint condyles with a small sound head for 2 to 3 minutes per side

Other: conventional therapyOther: low level laser therapy

low level laser therapy (groupII)

EXPERIMENTAL

LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.

Other: low level laser therapy

Interventions

Exercise therapeutic Ultrasound

Also known as: I
conventional therapy (group I)

LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.

Also known as: II
conventional therapy (group I)low level laser therapy (groupII)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients are diagnosed as myofascial pain syndrome of TMJ.

You may not qualify if:

  • Presence of systematic musculo-articular pathologies.
  • Pregnant women.
  • History of facial trauma.
  • Facial palsy.
  • Fractures of the facial bones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 19, 2017

Study Start

December 10, 2016

Primary Completion

August 12, 2017

Study Completion

August 23, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09