Myofascial Pain SyndromeNCT06327204
Efficacy of Different Low Level Laser Therapy Sessions
A study testing 940-nm diode laser / one session, 940-nm diode laser / two session and 940-nm diode laser/ three session in people with Myofascial Pain Syndrome, run by October 6 University at 1 site in Egypt.
Trial summary
Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- 940-nm diode laser / one session, 940-nm diode laser / two session and 940-nm diode laser/ three session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Dec 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
- presence of one or more trigger points in the masseter muscle
- no history of any invasive procedures of the related masseter muscle.
Who cannot join
- any painful conditions affecting the orofacial region
- any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
- pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Different Low Level Laser Therapy Sessions in Management of Masseter Muscle Trigger Points
Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.
Read the detailed description
Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- 940-nm diode laser / one session, 940-nm diode laser / two session, 940-nm diode laser/ three session
- Keywords
- Trigger Point Pain, Myofascial, Laser therapy
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
940-nm diode laser / one sessionDevice
laser therapy using a 940-nm diode laser / one session per week
940-nm diode laser / two sessionDevice
laser therapy using a 940-nm diode laser / two session per week
940-nm diode laser/ three sessionDevice
laser therapy using a 940-nm diode laser / three session per week
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | patient received one session / week Receives: Device: 940-nm diode laser / one session |
| group II | Active comparator | patient received two session / week Receives: Device: 940-nm diode laser / two session |
| Group III | Active comparator | Patient received three session / week Receives: Device: 940-nm diode laser/ three session |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
a 10-point visual analogue score
Measured: 8 weeks
Secondary outcomes (2)
maximum mouth opening
measuring the interincisal distance between the upper and lower central incisors
Measured: 8 weeks
quality of life questioner
Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies 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
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ahmed AlAraby, October 6 University
- Investigators
- amany Ahmed, PhD, Principal investigator, faculty of dentistry, October 6 University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327204
- Sponsor's protocol ID
- Low Level laser 24
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
PubMed 23318917Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572012000600002.
PubMed 23329239Mahmoud NR, Shehab WI, AlAraby AA, Habaka YF. Efficacy of different low-level laser therapy sessions in the management of masseter muscle trigger points. BMC Oral Health. 2024 Sep 26;24(1):1125. doi: 10.1186/s12903-024-04780-y.
PubMed 39327563
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Low Level Laser Therapy Sessions in Management of Masseter Muscle Trigger Points
- ClinicalTrials.gov ID
- NCT06327204
- Acronym / sponsor ID
- Low Level laser 24
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Trigger Point Pain, Myofascial, Laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Mar 2024 (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.
Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.
Detailed description
Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: 940-nm diode laser / one sessionpatient received one session / week |
| group II | Active comparator | Device: 940-nm diode laser / two sessionpatient received two session / week |
| Group III | Active comparator | Device: 940-nm diode laser/ three sessionPatient received three session / week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
- presence of one or more trigger points in the masseter muscle
- no history of any invasive procedures of the related masseter muscle.
Key exclusion criteria (3 listed)
- any painful conditions affecting the orofacial region
- any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
- pregnancy and lactation.
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 |
|---|---|---|
| 940-nm diode laser / one sessionlaser therapy using a 940-nm diode laser / one session per week | Device | Group I |
| 940-nm diode laser / two sessionlaser therapy using a 940-nm diode laser / two session per week | Device | group II |
| 940-nm diode laser/ three sessionlaser therapy using a 940-nm diode laser / three session per week | Device | Group III |
Primary outcome
pain score
Time frame: 8 weeks
a 10-point visual analogue score
2 secondary outcomes
maximum mouth opening
Time frame: 8 weeks
quality of life questioner
Time frame: 8 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 25 Mar 2024.
- Background: PubMed 23318917Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
- Background: PubMed 23329239Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572012000600002.
- Derived from this study: PubMed 39327563Mahmoud NR, Shehab WI, AlAraby AA, Habaka YF. Efficacy of different low-level laser therapy sessions in the management of masseter muscle trigger points. BMC Oral Health. 2024 Sep 26;24(1):1125. doi: 10.1186/s12903-024-04780-y.
- Individual participant dataSharing planned: No
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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.
amany Ahmed, PhD principal investigator
faculty of dentistry, October 6 University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 940-nm diode laser / one session, 940-nm diode laser / two session and 940-nm diode laser/ three session in people with Myofascial Pain Syndrome, run by October 6 University at 1 site in Egypt.
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 3 inclusion and 3 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 25 Mar 2024. 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 Egypt. 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?
pain score (time frame: 8 weeks). 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 NCT06327204, which also lists 3 linked publications.
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 25 Mar 2024.