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Clinical Trials/NCT03400462
NCT03400462
Completed
Not Applicable

Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients

Pomeranian Medical University Szczecin0 sites90 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
oral appliance
Conditions
Temporomandibular Disorder
Sponsor
Pomeranian Medical University Szczecin
Enrollment
90
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
December 12, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pomeranian Medical University Szczecin
Responsible Party
Principal Investigator
Principal Investigator

Dalewski Bartosz

DMD, PhD

Pomeranian Medical University Szczecin

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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

Intervention: oral appliance

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

Intervention: dry needling

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

Intervention: NSAID

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

Intervention: oral appliance

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.

Intervention: oral appliance

Outcomes

Primary Outcomes

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)

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