Back to resultsEffectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy protocol
Effleurage
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
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.
Sites / Locations
- University of Alcalá
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual Therapy protocol
Effleurage
Arm Description
Massages, mobilisation and stretching techniques in the most painful joint
Superficial massage in the most painful joint.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
It's an instrument to measure subjective pain intensity. It consists of a horizontal line of ten centimetres in length. On the left side appears the description of "no pain" and on the right side "the worst unimaginable pain". The patient is asked to draw a line at the point where he would place the intensity of his pain. Subsequently, it will be measured with a millimeter ruler from the left end to the point indicated by the patient. It will be the way to express in millimeters the intensity of pain. A minimum change of between 1.5 and 2.4 is required to be clinically significant, taking as reference the significant minimum change of subjects with nonspecific neck pain.
Oral opening
It will use a rule of fifteen centimetres (starting from 0), to measure the maximum painless opening and the maximum total opening. The opening will be the measurement that is between the lower part of the incisors of the upper jaw and the upper part of the incisors of the lower jaw, not counting the vertical overbite. The patient will be asked to open their mouth as much as possible without pain and also as much as possible until their pain tolerance. It will be analyzed taking three measurements with a rest's interval of 30 seconds. The three measurements will be added up and the average will be taken to obtain the final result. The minimum detectable change to be clinically significant is 5 to 9 mm.
Pressure algometry measurement
It measures the pain of the main masticatory muscles (temporal muscle, masseter muscle and lateral pterygoid muscle). The pain's pressure is analyzed three times at each point. The three measurements will be added up and the average will be taken to obtain the final result.
The patient is in supine, the investigators apply the tip of the algometer perpendicular to the muscle maintaining a pressure, which will progressively increase up to 1kg / cm2. Participants will be instructed to make a nonverbal signal at the time they start to experience pain, in order to obtain an accurate record. The minimum detectable change to be clinically significant is 1.13kg / cm2, taking as reference the nonspecific neck pain.
Secondary Outcome Measures
Self-perceived effect
The effect and the level of patients' satisfaction will be measured, through a scale of 11 points. Patients will draw a circle depending on the change they have experienced from -5 (much worse), passing through 0 (unchanged) to the +5 (full recovery).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03556150
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
September 3, 2018 (Actual)
Study Completion Date
September 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy protocol
Arm Type
Experimental
Arm Description
Massages, mobilisation and stretching techniques in the most painful joint
Arm Title
Effleurage
Arm Type
Active Comparator
Arm Description
Superficial massage in the most painful joint.
Intervention Type
Other
Intervention Name(s)
Manual Therapy protocol
Intervention Description
This protocol consists of:
Six minutes of joint's mobilisation (two minutes of each technique).
Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
Three minutes of trigemino's nerve stretching.
Intervention Type
Other
Intervention Name(s)
Effleurage
Intervention Description
The protocol consists of:
Five minutes in temporal muscle.
Ten minutes superficial massage in the neck and cheek of the most painful joint.
Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
It's an instrument to measure subjective pain intensity. It consists of a horizontal line of ten centimetres in length. On the left side appears the description of "no pain" and on the right side "the worst unimaginable pain". The patient is asked to draw a line at the point where he would place the intensity of his pain. Subsequently, it will be measured with a millimeter ruler from the left end to the point indicated by the patient. It will be the way to express in millimeters the intensity of pain. A minimum change of between 1.5 and 2.4 is required to be clinically significant, taking as reference the significant minimum change of subjects with nonspecific neck pain.
Time Frame
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.
Title
Oral opening
Description
It will use a rule of fifteen centimetres (starting from 0), to measure the maximum painless opening and the maximum total opening. The opening will be the measurement that is between the lower part of the incisors of the upper jaw and the upper part of the incisors of the lower jaw, not counting the vertical overbite. The patient will be asked to open their mouth as much as possible without pain and also as much as possible until their pain tolerance. It will be analyzed taking three measurements with a rest's interval of 30 seconds. The three measurements will be added up and the average will be taken to obtain the final result. The minimum detectable change to be clinically significant is 5 to 9 mm.
Time Frame
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.
Title
Pressure algometry measurement
Description
It measures the pain of the main masticatory muscles (temporal muscle, masseter muscle and lateral pterygoid muscle). The pain's pressure is analyzed three times at each point. The three measurements will be added up and the average will be taken to obtain the final result.
The patient is in supine, the investigators apply the tip of the algometer perpendicular to the muscle maintaining a pressure, which will progressively increase up to 1kg / cm2. Participants will be instructed to make a nonverbal signal at the time they start to experience pain, in order to obtain an accurate record. The minimum detectable change to be clinically significant is 1.13kg / cm2, taking as reference the nonspecific neck pain.
Time Frame
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 Outcome Measure Information:
Title
Self-perceived effect
Description
The effect and the level of patients' satisfaction will be measured, through a scale of 11 points. Patients will draw a circle depending on the change they have experienced from -5 (much worse), passing through 0 (unchanged) to the +5 (full recovery).
Time Frame
Measurements will be taken one hour after the last session and one month after the last session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz M. Bravo, Physiotherapy
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inmaculada T. Tejada, Physiotherapy
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alcalá
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
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