Clinical trial NCT03556150: Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
Official title: Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.

Detailed description: The investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. The treatment is meant for people who has masticatory muscle disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. The results will be register on the short and long term.

Eligibility criteria: Inclusion Criteria:

* Patients who are between 18 and 60 years old.
* Patients who have myofascial pain or myofascial pain and restricted oral opening taking into account Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
* Patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months.

Exclusion Criteria:

* Patients who cannot receive manual therapy.
* Patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system.
* Surgery intervention in the temporomandibular joint.
* Patients who have received physiotherapy sessions in the last six months.
* Red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis.
* Patients who lost their teeth (excluding the third molar) or people using a total or partial dentures.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
measure: Oral opening
timeFrame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
measure: Pressure algometry measurement
timeFrame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
Secondary outcomes:
measure: Self-perceived effect
timeFrame: Measurements will be taken one hour after the last session and one month after the last session.
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
affiliation: Investigator
name: Beatriz M. Bravo, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Inmaculada T. Tejada, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
References: