Low Level Laser TherapyNCT03287531
Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction
A study testing conventional therapy and low level laser therapy in people with Low Level Laser Therapy and Temporomandibular Joint Dysfunction, run by Emad Eldin Mohamed.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Level Laser Therapy, Temporomandibular Joint Dysfunction
- What is being tested?
- conventional therapy and low level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2016to 23 Aug 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients are diagnosed as myofascial pain syndrome of TMJ.
Who cannot join
- Presence of systematic musculo-articular pathologies.
- Pregnant women.
- History of facial trauma.
- Facial palsy.
- Fractures of the facial bones.
About this study
Official title: Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients
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.
Read the detailed description
METHODOLOGY
Subjects: This prospective study was conducted on thirty patients of both genders with myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into this study according to the following criteria:
- Being tested
- conventional therapy, low level laser therapy
- Keywords
- conventional therapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
Also called I
Exercise therapeutic Ultrasound
low level laser therapyOther
Also called II
LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: conventional therapy; Other: 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. Receives: Other: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain algometry
Measured: 4 weeks
Secondary outcomes (1)
Jaw Functional questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start10 Dec 2016
- Primary completion12 Aug 2017
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Laser TherapyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emad Eldin Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emad Eldin Mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287531
- Sponsor's protocol ID
- 00500
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients
- ClinicalTrials.gov ID
- NCT03287531
- Acronym / sponsor ID
- 00500
- Keywords
- conventional therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emad Eldin MohamedUniversity, hospital or other
- Study start
- 10 Dec 2016 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 19 Sep 2017 (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.
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.
Detailed description
METHODOLOGY
Subjects: This prospective study was conducted on thirty patients of both genders with myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into this study according to the following criteria:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional therapy (group I) | Experimental | Other: conventional therapy, Other: low level laser therapy1. 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 |
| low level laser therapy (groupII) | Experimental | Other: low level laser therapyLLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients are diagnosed as myofascial pain syndrome of TMJ.
Key exclusion criteria (5 listed)
- Presence of systematic musculo-articular pathologies.
- Pregnant women.
- History of facial trauma.
- Facial palsy.
- Fractures of the facial bones.
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 |
|---|---|---|
| conventional therapyAlso: IExercise therapeutic Ultrasound | Other | conventional therapy (group I) |
| low level laser therapyAlso: IILLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week. | Other | conventional therapy (group I), low level laser therapy (groupII) |
Primary outcome
Pain algometry
Time frame: 4 weeks
1 secondary outcome
Jaw Functional questionnaire
Time frame: 4 weeks
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 19 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy and low level laser therapy in people with Low Level Laser Therapy and Temporomandibular Joint Dysfunction, run by Emad Eldin Mohamed.
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 1 inclusion and 5 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain algometry (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2017.