Muscle PainNCT03421028
Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management
A study testing Electromyography Biofeedback and Classic treatment for myogenous TMD in people with Muscle Pain and Feedback, Psychological, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Pain, Feedback, Psychological, Craniomandibular Disorders
- What is being tested?
- Electromyography Biofeedback and Classic treatment for myogenous TMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of myalgia in accordance to Diagnostic Criteria for Temporomandibular Disorders
- full dentition or single tooth loss
- age between 18 and 70
Who cannot join
- age under 18
- age over 70
- terminal general diseases
- severe mental disorders
- severe neurological disorders
- intake of drugs affecting muscle function
Show all 17Show fewer
- edentulism or destruction of dentition
- alcoholism
- drug addiction
- history of severe trauma in the head and neck region
- severe pathology of temporomandibular joints
- congenital or acquired craniofacial deformity
- patients suffering from neuropathic pain
- patients with craniofacial inflammation
- patients undergoing orthodontic treatment
- pregnancy
- significant postural defect
Trial locations and contacts
1 site in 1 country.
Mieszko Więckiewicz, D.M.D.Ph.D. contact
About this study
Official title: The Evaluation of EMG-biofeedback Therapy Efficiency in Management of Masticatory Muscles Pain
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.
Read the detailed description
- 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:
- Experimental group 1 - patients diagnosed with myalgia subjected to 4 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Experimental group 2 - patients diagnosed with myalgia subjected to 8 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Control group - patients diagnosed with myalgia subjected to physiotherapy (manual therapy), stabilization splint usage and counseling (20 adults).
- Methods:
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.
- Conditions
- Muscle Pain, Feedback, Psychological, Craniomandibular Disorders, Temporomandibular Disorder, Sleep
- Being tested
- Electromyography Biofeedback, Classic treatment for myogenous TMD
- Medical subject headings
- Myalgia, Craniomandibular Disorders, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography BiofeedbackDevice
Also called EMG-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)
Classic treatment for myogenous TMDOther
Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients with masticatory muscle pain treated with occlusal splint, physiotherapy and counseling Receives: Other: Classic treatment for myogenous TMD |
| Experimental group 1 | Experimental | Patients diagnosed with masticatory muscle pain treated with 4 meetings of EMG-biofeedback assisted training Receives: Device: Electromyography Biofeedback |
| Experimental group 2 | Experimental | Patients diagnosed with masticatory muscle pain treated with 8 meetings of EMG-biofeedback Receives: Device: Electromyography Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: before the treatment, after 8 weeks of training
Secondary outcomes (9)
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: after treatment and up to 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Florjański, Wroclaw Medical University
- Investigators
- Mieszko Więckiewicz, D.M.D.Ph.D., Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421028
- Sponsor's protocol ID
- WMU2/2017
- Status last verified
- Jul 2021
- First submitted
- 2 Jan 2018
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of EMG-biofeedback Therapy Efficiency in Management of Masticatory Muscles Pain
- ClinicalTrials.gov ID
- NCT03421028
- Acronym / sponsor ID
- WMU2/2017
- Conditions
- Muscle Pain, Feedback, Psychological, Craniomandibular Disorders, Temporomandibular Disorder, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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:
- Experimental group 1 - patients diagnosed with myalgia subjected to 4 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Experimental group 2 - patients diagnosed with myalgia subjected to 8 EMG-Biofeedback trainings. The group will include approximately 20 adults.
- Control group - patients diagnosed with myalgia subjected to physiotherapy (manual therapy), stabilization splint usage and counseling (20 adults).
- Methods:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Classic treatment for myogenous TMDPatients with masticatory muscle pain treated with occlusal splint, physiotherapy and counseling |
| Experimental group 1 | Experimental | Device: Electromyography BiofeedbackPatients diagnosed with masticatory muscle pain treated with 4 meetings of EMG-biofeedback assisted training |
| Experimental group 2 | Experimental | Device: Electromyography BiofeedbackPatients diagnosed with masticatory muscle pain treated with 8 meetings of EMG-biofeedback |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of myalgia in accordance to Diagnostic Criteria for Temporomandibular Disorders
- full dentition or single tooth loss
- age between 18 and 70
Key exclusion criteria (17 listed)
- age under 18
- age over 70
- terminal general diseases
- severe mental disorders
- severe neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyography BiofeedbackAlso: EMG-BiofeedbackEMG-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) | Device | Experimental group 1, Experimental group 2 |
| Classic treatment for myogenous TMDCombination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling | Other | Control group |
Primary outcome
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1
Time frame: before the treatment, after 4 weeks of training
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
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 2
Time frame: before the treatment, after 8 weeks of training
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
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 1
Time frame: before the treatment, after 4 weeks of training
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
The effect of EMG biofeedback therapy on pain symptoms measured by pressure pain threshold in Experimental group 2
Time frame: before the treatment, after 8 weeks of training
This effect will be assessed by comparing pressure pain threshold pre- and post- biofeedback therapy. Pressure pain threshold will be measured with dolorimeter.
9 secondary outcomes
Effect of EMG biofeedback therapy on psychological parameters and its persistence in time measured by Beck Anxiety Inventory (BAI).
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)
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)
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).
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)
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)
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
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)
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
Time frame: after treatment and up to 12 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mieszko Więckiewicz, D.M.D.Ph.D. contact
Mieszko Więckiewicz, D.M.D.Ph.D. study chair
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography Biofeedback and Classic treatment for myogenous TMD in people with Muscle Pain and Feedback, Psychological, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Florjański, D.M.D.P.H.D. (+48783602042, wojciech.florjanski@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of EMG biofeedback therapy on pain symptoms measured by Numerical Rating Scale (NRS) in Experimental group 1 (time frame: before the treatment, after 4 weeks of training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.