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

NCT03400462 | Completed DMC

• 1 other identifier: KB-0012/83/16
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Temporomandibular Disorder

Keywords

Dry needling, occlusal splint, NSAID, nimesulide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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.

Device: oral appliance

Interventions

NSAID DRUG

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.

Also known as: nimesulid

antiinflammatory drugs + splint therapy

oral appliance DEVICE

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.

antiinflammatory drugs + splint therapy; dry needling + oral appliance; splint therapy

dry needling OTHER

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)

dry needling + oral appliance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Dry Needling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Bartosz Dalewski, DMD,PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, PhD

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 17, 2018
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 12, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01