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

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Device: oral appliance; Drug: NSAID; Other: dry needling

• Registration Number: NCT03400462
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-12-12
• Status Verified: 2018-01
• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-12
• Last Update Submitted: 2018-01-12
• Study First Posted: 2018-01-17
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dry needling + oral appliance	dry needling	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
dry needling + oral appliance	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
antiinflammatory drugs + splint therapy	oral appliance	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
splint therapy	oral appliance	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.
antiinflammatory drugs + splint therapy	NSAID	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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	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)