Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
NCT ID: NCT03400462
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2016-07-01
2017-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dry needling + oral appliance
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
oral appliance
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 needling
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)
antiinflammatory drugs + splint therapy
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
NSAID
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 appliance
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.
splint therapy
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.
oral appliance
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.
Interventions
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NSAID
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 appliance
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 needling
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no other analgesic treatment in the area of head and neck during last 12 months
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Pomeranian Medical University Szczecin
OTHER
Responsible Party
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Dalewski Bartosz
DMD, PhD
Principal Investigators
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Bartosz Dalewski, DMD,PhD
Role: PRINCIPAL_INVESTIGATOR
Pomeranian Medical University
Other Identifiers
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KB-0012/83/16
Identifier Type: -
Identifier Source: org_study_id
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