An interventional study of Electromyography Biofeedback and Classic treatment for myogenous TMD in Muscle Pain, Feedback, Psychological and Craniomandibular Disorders, sponsored by Wroclaw Medical University. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Treatment
This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased tension of muscles occurring in patients with temporomandibular disorders (TMD). During the study Electromyography Biofeedback (EMG-Biofeedback)- assisted training lowering muscle tension will be used. The patients will undergo 4 or 8 meetings of EMG-Biofeedback - assisted training Than the patients will be reevaluated after 6 and 12 weeks.
The Aim:
The aim of the study is to evaluate beneficial effects of biofeedback therapy in reducing pain, increased tension of masticatory muscles occurring in patients with myogenous TMD and if the therapy influences psychological and sleep parameters. Also to verify if the effect of the therapy persists in time.
Patients:
Adult patients diagnosed with masticatory muscles myalgia will be included in this study. All participants will be evaluated in accordance to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Intensity of pain in the masticatory muscles will be defined using the Numerical Rating Scale (NRS). The pressure pain threshold (PPT) will be assessed with an dolorimeter and noticed on DC/TMD pain drawing diagram. Each of the qualified patients will also undergo the electromyography of temporal and masseter muscles. All participants will fill in questionnaires (Graded Chronic Pain Scale (GCPS), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Beck Anxiety Inventory (BAI) and Perceived Stress Scale-10 (PSS-10) and Somatic Symptom Scale-8 (SSS-8).
Patients qualified to the experimental groups will be divided in to 2 subgroups composed of 20 participants each.
Experimental group 1 will undergo a cycle of 4 meetings (1 per week) of 20 minute EMG-Biofeedback- assisted training decreasing the masseter and temporalis muscle tension. 10 minutes of training for each group of muscle.
Experimental group 2 will undergo a cycle of 8 meetings (1 per week) of 20 minute EMG-Biofeedback- assisted training decreasing the masseter and temporalis muscle tension. 10 minutes of training for each group of muscle.
Postcycle examination:
After completing the cycle, patients from the study group and control group will be reevaluated. All participants will be evaluated in accordance to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Intensity of pain in the masticatory muscles will be defined using the Numerical Rating Scale (NRS). The pressure pain threshold (PPT) will be assessed with an dolorimeter and noticed on DC/TMD pain drawing diagram. Each of the qualified patients will also undergo the electromyography of temporal and masseter muscles. All participants will fill in questionnaires (Graded Chronic Pain Scale (GCPS), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9), Beck Anxiety Inventory (BAI) and Perceived Stress Scale-10 (PSS-10) and Somatic Symptom Scale-8 (SSS-8).
The postcycle examination will take place after last planned training and during follow-ups - 6 and 12 weeks after completion of EMG-Biofeedback therapy.
256 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 216 interventional studies indexed under Myalgia.
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Exclusion Criteria:
Patients with masticatory muscle pain treated with occlusal splint, physiotherapy and counseling
Other: Classic treatment for myogenous TMD
Patients diagnosed with masticatory muscle pain treated with 4 meetings of EMG-biofeedback assisted training
Device: Electromyography Biofeedback
Patients diagnosed with masticatory muscle pain treated with 8 meetings of EMG-biofeedback
Device: Electromyography Biofeedback
EMG-Biofeedback- assisted training is a method in which electrodes situated on the surface of the skin detect small voltage changes which arise from the working muscles (in this case masseter and temporalis muscles). The voltage is transformed into a visual or sound time-variable signal which gives the patient feedback as he willingly tries to change the muscle tension (in this case to lower the excessive masseter tension)
Also known as: EMG-Biofeedback
Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1
This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
Time frame: before the treatment, after 4 weeks of training
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 2
This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
Time frame: before the treatment, after 8 weeks of training
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 1
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
Time frame: before the treatment, after 4 weeks of training
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
Time frame: before the treatment, after 8 weeks of training
Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Beck Anxiety Inventory (BAI).
This effect will be assessed by comparing the results of Beck Anxiety Inventory. Each participant will fill in Beck Anxiety Inventory pre- post therapy and during the follow-ups. The total score is calculated by finding the sum of the 21 items. Total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".
Time frame: before the treatment and up to 12 weeks after completion of the treatment
Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Patient Health Questionnaire-9 (PHQ-9)
This effect will be assessed by comparing the results of Patient Health Questionnaire-9 (PHQ-9) . Each participant will fill in Patient Health Questionnaire - 9 pre- post therapy and during the follow-ups. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Time frame: before the treatment and up to 12 weeks after completion of the treatment
Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Perceived Stress Scale-10 (PSS-10)
This effect will be assessed by comparing the results of Perceived Stress Scale-10 (PSS-10). Each participant will fill in Perceived Stress Scale -10 pre- post therapy and during the follow-ups. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.
Time frame: before the treatment and up to 12 weeks after completion of the treatment
Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Somatic Symptom Scale-8 (SSS-8).
This effect will be assessed by comparing the results Somatic Symptom Scale-8 (SSS-8). Each participant will fill in Somatic Symptom Scale-8 (SSS-8) pre- post therapy and during the follow-ups. SSS-8 total score ranges from 0 to 32 points, where 0-3 points means no to minimal severity, 4-7 points - low severity, 8-11 points - medium severity, 12-15 points - high severity, 16-32 points - very high severity.
Time frame: before the treatment and up to 12 weeks after completion of the treatment
Effect of EMG biofeedback therapy on sleep quality and its persistence in time measured by Pittsburgh Sleep Quality Index (PSQI)
This effect will be assessed by comparing the results of Pittsburgh Sleep Quality Index (PSQI). Each participant will fill in Pittsburgh Sleep Quality Index pre- post therapy and during the follow-ups. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21, where lower scores mean better sleep quality.
Time frame: before the treatment and up to 12 weeks after completion of the treatment
Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by Numerical Rating Scale (NRS)
This effect will be assessed by comparing Numerical Rating Scale (NRS) between studied and control group. The results will be compared after treatment and during follow-ups. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
Time frame: after treatment and up to 12 weeks later
Effectiveness of EMG biofeedback therapy on pain symptoms in comparison to "standard" treatment measured by pressure pain threshold
This effect will be assessed by comparing pressure pain threshold measured with dolorimeter between studied and control group. The results will be compared after treatment and during follow-ups.
Time frame: after treatment and up to 12 weeks later
Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by Numerical Rating Scale (NRS)
This effect will be assessed by comparing Numerical Rating Scale (NRS) pre- and post- biofeedback therapy. A numerical rating scale (NRS) requires the patient to rate their pain on a scale 0-10, where 0 is no pain and 10 is the worst pain imaginable
Time frame: after treatment and up to 12 weeks later
Persistence in time of EMG biofeedback therapy effects on pain symptoms measured by pressure pain threshold
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
Time frame: after treatment and up to 12 weeks later
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2022; primary completion for Sep 2023, 20 months later.
Of 101 non-industry interventional studies with no phase under Myalgia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 20 months is above that.
Counting every sponsor, half of 111 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Wroclaw Medical University