Myofascial Pain SyndromeNCT06442553
New Generation Low Level Laser Effect in Myofacial Pain Syndrome
A study testing GRR laser and Nd:YAG laser in people with Myofascial Pain Syndrome, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- GRR laser and Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 1 Apr 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.
Who cannot join
- Patients with internal TMJ irregularities or degenerative joint changes,
- patients with restricted mouth opening, deviation or deflection,
- patients with systemic diseases,
- pregnant women,
- patients who had received MPS treatment within the previous year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İrem Karagözoğlu
Şehitkamil, Gazi̇antep, 27310
About this study
Official title: New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial
Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.
Read the detailed description
A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- GRR laser, Nd:YAG laser
- Keywords
- low level laser therapy, myofascial pain syndrome, bite forces, visual analogue scale, gaalas laser, neodymium doped yttrium aluminum garnet lasers
- 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.
GRR laserDevice
A total of 15 sessions were applied to each patient for three weeks, five times per week.
Nd:YAG laserDevice
A total of 10 sessions, five sessions per week, were applied
| Study group | Role | What they receive |
|---|---|---|
| GRR laser | Experimental | patients received 15 sessions GRR laser treatment for 3 weeks Receives: Device: GRR laser |
| Nd:YAG Laser | Experimental | patients received 10 sessions Nd:YAG laser treatment for 2 weeks Receives: Device: Nd:YAG laser |
| placebo | Placebo comparator | patients received 10 sessions emission-free laser treatment for 2 weeks Receives: Device: Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
Patients were asked to rate the intensity of their pain on a scale from 0 to 10. They were told that a score of 0 meant no pain, a score of 10 meant severe pain and a score of 5 meant moderate pain
Measured: baseline and week 3
change from baseline in oxygen concentration in the massater muscle at week 3
oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS (ARGES cerebro, Hemosoft Inc., Ankara, Turkey) before and after treatment for each patient.
Measured: baseline and week 3
change from baseline in bite force values at week 3
bite force values were recorded by Flexiforce sensors before and after treatment for each patient.
Measured: baseline and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jan 2024
- Primary completion25 Mar 2024
- Study completion1 Apr 2024
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 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İREM KARAGOZOGLU, University of Gaziantep
- Investigators
- İREM KARAGÖZOĞLU, Principal investigator, GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442553
- Sponsor's protocol ID
- KARAGOZOGLUI
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karagozoglu I, Demirkol N, Parlar Oz O, Yilmaz S, Ozcan M. New generation low level laser effect on masseter muscle oxygenation, bite force and algometric changes in myofacial pain syndrome: a randomised, placebo-controlled clinical trial. Lasers Med Sci. 2025 Jan 27;40(1):48. doi: 10.1007/s10103-024-04272-z.
PubMed 39869221
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06442553
- Acronym / sponsor ID
- KARAGOZOGLUI
- Conditions
- Myofascial Pain Syndrome
- Keywords
- low level laser therapy, myofascial pain syndrome, bite forces, visual analogue scale, gaalas laser, neodymium doped yttrium aluminum garnet lasers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Jun 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.
Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.
Detailed description
A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GRR laser | Experimental | Device: GRR laserpatients received 15 sessions GRR laser treatment for 3 weeks |
| Nd:YAG Laser | Experimental | Device: Nd:YAG laserpatients received 10 sessions Nd:YAG laser treatment for 2 weeks |
| placebo | Placebo comparator | Device: Nd:YAG laserpatients received 10 sessions emission-free laser treatment for 2 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.
Key exclusion criteria (5 listed)
- Patients with internal TMJ irregularities or degenerative joint changes,
- patients with restricted mouth opening, deviation or deflection,
- patients with systemic diseases,
- pregnant women,
- patients who had received MPS treatment within the previous year
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 |
|---|---|---|
| GRR laserA total of 15 sessions were applied to each patient for three weeks, five times per week. | Device | GRR laser |
| Nd:YAG laserA total of 10 sessions, five sessions per week, were applied | Device | Nd:YAG Laser, placebo |
Primary outcome
change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
Time frame: baseline and week 3
Patients were asked to rate the intensity of their pain on a scale from 0 to 10. They were told that a score of 0 meant no pain, a score of 10 meant severe pain and a score of 5 meant moderate pain
change from baseline in oxygen concentration in the massater muscle at week 3
Time frame: baseline and week 3
oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS (ARGES cerebro, Hemosoft Inc., Ankara, Turkey) before and after treatment for each patient.
change from baseline in bite force values at week 3
Time frame: baseline and week 3
bite force values were recorded by Flexiforce sensors before and after treatment for each patient.
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 4 Jun 2024.
- Derived from this study: PubMed 39869221Karagozoglu I, Demirkol N, Parlar Oz O, Yilmaz S, Ozcan M. New generation low level laser effect on masseter muscle oxygenation, bite force and algometric changes in myofacial pain syndrome: a randomised, placebo-controlled clinical trial. Lasers Med Sci. 2025 Jan 27;40(1):48. doi: 10.1007/s10103-024-04272-z.
- 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.
İREM KARAGÖZOĞLU principal investigator
GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRR laser and Nd:YAG laser in people with Myofascial Pain Syndrome, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 4 Jun 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3 (time frame: baseline and week 3). The study lists 3 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 NCT06442553, 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 4 Jun 2024.