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

The aim of this study was to compare the effectiveness of myofascial pain treatment methods.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Device: oral appliance; Other: dry needling; Drug: NSAID

Detailed Description

Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Other: 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)
Experimental: 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	Device: 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.; Drug: 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.; Other Names: nimesulid
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Investigators: Principal Investigator: Bartosz Dalewski, DMD,PhD, Pomeranian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Dry needling, occlusal splint, NSAID, nimesulide
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: KB-0012/83/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No