Clinical trial NCT05618938: Effects of Rocabado's Approach Versus Kraus Exercise Therapy
Official title: Effects of Rocabado's Approach Versus Kraus Exercise Therapy on Pain and Disability in Patients With Temporomandibular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Dysfunction
Keywords: Rocabado's Approach
Kraus exercises
Disability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.

Detailed description: A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:

* Male and female between the ages of 30 to 60 years
* Patients with jaw pain
* Patients with limited jaw range of motion and associated joint pain
* Patients with TMJ clicking sounds
* Patients with pain upon muscle and joint palpation

Exclusion Criteria:

* Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus;
* Neurological problems that could potentially cause the tinnitus
* Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4th week
measure: Temporomandibular Joint Disability Index Questionnaire:
timeFrame: 4th week
measure: Fonseca's Questionnaire for severity
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital
state: Punjab
Study officials:
affiliation: Riphah International University,Lahore
name: Samrood Akram, Mphil
role: PRINCIPAL_INVESTIGATOR
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