NCT05810831

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 15, 2023

Last Update Submit

March 31, 2023

Conditions

Pain, Joint

Outcome Measures

Primary Outcomes (1)

  • Massage exercises , Massage with post isometric relaxation exercises

    6 Months

Study Arms (2)

Massage with post isometric relaxation exercises

EXPERIMENTAL
Diagnostic Test: Massage with post isometric relaxation exercises

Massage

EXPERIMENTAL
Diagnostic Test: Massage

Interventions

Massage with post isometric relaxation exercisesDIAGNOSTIC_TEST

Post isometric relaxation will be performed in supine position with neutrally positioned head.

Massage with post isometric relaxation exercises
MassageDIAGNOSTIC_TEST

conservative physiotherapy protocol including massage

Massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share