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

NCT ID: NCT03400462

Last Updated: 2018-01-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-12-12

Brief Summary

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

Detailed Description

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

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type EXPERIMENTAL

oral appliance

Intervention Type 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.

dry needling

Intervention Type 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)

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

Group Type EXPERIMENTAL

NSAID

Intervention Type 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.

oral appliance

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

oral appliance

Intervention Type 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.

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.

Intervention Type DRUG

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.

Intervention Type DEVICE

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)

Intervention Type OTHER

Other Intervention Names

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nimesulid

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Dalewski Bartosz

DMD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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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