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

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NSAID
oral appliance
dry needling
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Dry needling, occlusal splint, NSAID, nimesulide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    dry needling + oral appliance

    antiinflammatory drugs + splint therapy

    splint therapy

    Arm Description

    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

    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 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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 1, 2018
    Last Updated
    January 12, 2018
    Sponsor
    Pomeranian Medical University Szczecin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03400462
    Brief Title
    Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
    Official Title
    Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    November 1, 2017 (Actual)
    Study Completion Date
    December 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pomeranian Medical University Szczecin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder
    Keywords
    Dry needling, occlusal splint, NSAID, nimesulide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dry needling + oral appliance
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    antiinflammatory drugs + splint therapy
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    splint therapy
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    NSAID
    Other Intervention Name(s)
    nimesulid
    Intervention Description
    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
    Device
    Intervention Name(s)
    oral appliance
    Intervention Description
    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
    Other
    Intervention Name(s)
    dry needling
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    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)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bartosz Dalewski, DMD,PhD
    Organizational Affiliation
    Pomeranian Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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