Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
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|ClinicalTrials.gov Identifier: NCT03556150|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Disorder||Other: Manual Therapy protocol Other: Effleurage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders: A Randomized Controlled Trial|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Manual Therapy protocol
Massages, mobilisation and stretching techniques in the most painful joint
Other: Manual Therapy protocol
This protocol consists of:
Active Comparator: Effleurage
Superficial massage in the most painful joint.
The protocol consists of:
- Visual Analogue Scale [ 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. ]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 [ 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. ]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 [ 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. ]
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.
- Self-perceived effect [ Time Frame: Measurements will be taken one hour after the last session and one month after the last session. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556150
|University of Alcalá|
|Alcalá De Henares, Madrid, Spain, 28801|
|Principal Investigator:||Beatriz M. Bravo, Physiotherapy||Investigator|
|Principal Investigator:||Inmaculada T. Tejada, Physiotherapy||Investigator|