Campus Científico Tecnológico UAH. AV. de León, 3A.
Alcalá de Henares, Madrid, 28804, Spain
NCT Number: NCT06502769
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Alcalá de Henares, Madrid, 28804, Spain
Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).
Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.
Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A therapeutic exercise program will be carried out
A PNE program will be carried out
Time frame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The CF-PDI is a self-administered questionnaire that measures pain and disability outcomes related to craniofacial pain. It consists of 21 items, with a score ranging from 0 to 63 points. A higher score reflects higher levels of disability.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The PCS consists of a self-administered questionnaire with 13 items for the evaluation of catastrophic thoughts. It is divided into three domains: helplessness, magnification and rumination. Higher values denote greater pain catastrophizing
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The Spanish version of the TSK-11 will be used to evaluate the fear of re-injury due to movement. This questionnaire has a structure of 11 items and 2 factors that includes avoidance and harm of activities. Higher scores reflect greater fear of movement
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The masseter and anterior temporal PPTs will be assessed bilaterally using an analog algometer. Measurements will be reported in kg/cm2. The points will always be evaluated in the same order and will be repeated three times, with an interval of 1 minute. For each point the average of the three measurements will be considered.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
PGIC will be used to assess perceived improvement after treatment (range, 0-7). Higher scores will indicate greater improvement
Contact information is provided by the study sponsor or research team.
Gema Bodes-Pardo, PhD
CONTACT
María Teresa Ortiz-Moreno, MSc
CONTACT
University of Alcala
Other
Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07153107
Chronic TMD Pain, Craniomandibular Disorders
Minneapolis, Minnesota, United States
View Trial DetailsNCT07664059
Craniomandibular Disorders, Jaw Diseases
View Trial DetailsNCT07614932
Craniomandibular Disorders, Jaw Diseases
Cairo, Egypt
View Trial DetailsNCT07125404
Anxiety Disorders, Anxiety State
Santiago, Santiago Metropolitan, Chile
View Trial Details