Temporomandibular DisorderNCT03400462
Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
A study testing NSAID, oral appliance and dry needling in people with Temporomandibular Disorder, run by Pomeranian Medical University Szczecin.
Trial summary
The aim of this study was to compare the effectiveness of myofascial pain treatment methods. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- NSAID, oral appliance and dry needling
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 12 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pain localized in the TMJ or in the preauricular area.
- no other analgesic treatment in the area of head and neck during last 12 months
Who cannot join
- inflammation in the oral cavity that emerge as a myofascial pain
- earlier splint therapy
- pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants
- systemic diseases e.g. rheumatic, metabolic
- lack of stability in the masticatory organ motor system
- masticatory organ injury
About this study
The aim of this study was to compare the effectiveness of myofascial pain treatment methods.
Read the detailed description
Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.
- Conditions
- Temporomandibular Disorder
- Being tested
- NSAID, oral appliance, dry needling
- Keywords
- Dry needling, occlusal splint, NSAID, nimesulide
- 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.
NSAIDDrug
Also called nimesulid
Nimesulide has anti-inflammatory and analgesic properties. Like other NSAIDs it inhibits the action of COX . If prostaglandins can not be further synthesized, so there is no factor able to excite local nociceptors. According to t must be taken regularly for a minimum 2 weeks to achieve appropriate blood concentration.
oral applianceDevice
The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.
dry needlingOther
Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd)
| Study group | Role | What they receive |
|---|---|---|
| dry needling + oral appliance | Experimental | Three visits are needed in this therapy method. Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, solution for skin disinfection, sterile gauze. Exposition time : 30 minutes once a week Receives: Device: oral appliance; Other: dry needling |
| antiinflammatory drugs + splint therapy | Experimental | Patient's instruction for NSAID use:
Nimesulide 2*100 mg/ 24 h- twice a day one pill of the 100 mg Nimesulide during 14 days Receives: Drug: NSAID; Device: oral appliance |
| splint therapy | Active comparator | Splint therapy is an useful treatment method for several group of patients e.g TMD patients, patients with retrodiscitis, patients with muscle pain disorders like local muscle soreness or chronic myalgia.
The patients have been instructed to use the appliance during nighttime. After 7 days the patient had to came back for a control visit. Receives: Device: oral appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is a continuous scale comprised of a horizontal line, usually 10 cm in length. "no pain" (score of 0) and "pain as bad as it could be (score of 10)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Jul 2016
- Primary completion1 Nov 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalewski Bartosz, Pomeranian Medical University Szczecin
- Investigators
- Bartosz Dalewski, DMD,PhD, Principal investigator, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400462
- Sponsor's protocol ID
- KB-0012/83/16
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
- ClinicalTrials.gov ID
- NCT03400462
- Acronym / sponsor ID
- KB-0012/83/16
- Conditions
- Temporomandibular Disorder
- Keywords
- Dry needling, occlusal splint, NSAID, nimesulide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 17 Jan 2018 (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.
The aim of this study was to compare the effectiveness of myofascial pain treatment methods.
Detailed description
Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dry needling + oral appliance | Experimental | Device: oral appliance, Other: dry needlingThree visits are needed in this therapy method. Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, solution for skin disinfection, sterile gauze. Exposition time : 30 minutes once a week |
| antiinflammatory drugs + splint therapy | Experimental | Drug: NSAID, Device: oral appliancePatient's instruction for NSAID use: Nimesulide 2*100 mg/ 24 h- twice a day one pill of the 100 mg Nimesulide during 14 days |
| splint therapy | Active comparator | Device: oral applianceSplint therapy is an useful treatment method for several group of patients e.g TMD patients, patients with retrodiscitis, patients with muscle pain disorders like local muscle soreness or chronic myalgia. The patients have been instructed to use the appliance during nighttime. After 7 days the patient had to came back for a control visit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pain localized in the TMJ or in the preauricular area.
- no other analgesic treatment in the area of head and neck during last 12 months
Key exclusion criteria (6 listed)
- inflammation in the oral cavity that emerge as a myofascial pain
- earlier splint therapy
- pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants
- systemic diseases e.g. rheumatic, metabolic
- lack of stability in the masticatory organ motor system
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 |
|---|---|---|
| NSAIDAlso: nimesulidNimesulide has anti-inflammatory and analgesic properties. Like other NSAIDs it inhibits the action of COX . If prostaglandins can not be further synthesized, so there is no factor able to excite local nociceptors. According to t must be taken regularly for a minimum 2 weeks to achieve appropriate blood concentration. | Drug | antiinflammatory drugs + splint therapy |
| oral applianceThe stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements. | Device | antiinflammatory drugs + splint therapy, dry needling + oral appliance, splint therapy |
| dry needlingEquipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) | Other | dry needling + oral appliance |
Primary outcome
Visual Analogue Scale
Time frame: 6 months
It is a continuous scale comprised of a horizontal line, usually 10 cm in length. "no pain" (score of 0) and "pain as bad as it could be (score of 10)
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 17 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Bartosz Dalewski, DMD,PhD principal investigator
Pomeranian Medical University
Questions about this trial
What is this clinical trial studying?
A study testing NSAID, oral appliance and dry needling in people with Temporomandibular Disorder, run by Pomeranian Medical University Szczecin.
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 2 inclusion and 6 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 17 Jan 2018. 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?
Visual Analogue Scale (time frame: 6 months). 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 17 Jan 2018.