search
Back to results

Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders

Primary Purpose

Pain, Joint

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage with post isometric relaxation exercises
Massage
Sponsored by
Superior University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria, absence of temporomandibular disc displacement with or without reduction, good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles), full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses Exclusion Criteria: earlier splint therapy, pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants), injury of masticatory organ, undergoing orthodontic treatment, inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Massage with post isometric relaxation exercises

    Massage

    Arm Description

    Outcomes

    Primary Outcome Measures

    Massage exercises , Massage with post isometric relaxation exercises

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 31, 2023
    Sponsor
    Superior University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05810831
    Brief Title
    Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders
    Official Title
    Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Superior University

    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
    To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Joint

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Massage with post isometric relaxation exercises
    Arm Type
    Experimental
    Arm Title
    Massage
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Massage with post isometric relaxation exercises
    Intervention Description
    Post isometric relaxation will be performed in supine position with neutrally positioned head.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Massage
    Intervention Description
    conservative physiotherapy protocol including massage
    Primary Outcome Measure Information:
    Title
    Massage exercises , Massage with post isometric relaxation exercises
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria, absence of temporomandibular disc displacement with or without reduction, good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles), full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses Exclusion Criteria: earlier splint therapy, pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants), injury of masticatory organ, undergoing orthodontic treatment, inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders

    We'll reach out to this number within 24 hrs