Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05426655
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2022-06-13
Brief Title:
Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia a Single Arm Study
Sponsor:
Jose Edgar Ferrandez Gomez
Organization:
Universidad de Murcia
Study Overview
Official Title:
Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia a Single Arm Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia is one of the most prevalent chronic widespread pain entities today One of the most common problems in patients with fibromyalgia are alterations of the temporomandibular region present in approximately 80 of the subjects being in turn alterations of muscular origin the most common with a prevalence of 84 One of the most promising therapeutic strategies is one that leads to self-management by the patient The main objective of this study is to analyze the effect of a self-management program for myalgia in the temporomandibular region in subjects with fibromyalgia For this an experimental study of the uncontrolled Clinical Trial type will be carried out Participants must be over 18 years of age have a diagnosis of fibromyalgia and have myalgia or myofascial pain syndrome in the temporomandibular region Demographic data mandibular function pain level quality of life related to oral health kinesiophobia anxiety and depression sleep patient oral habits catastrophizing knowledge about pain central sensitization self-efficacy coping with pain patient expectations and patient satisfaction with the treatment received An initial data collection will be carried out The intervention will be carried out in 3 online sessions in which different pain processes will be explained mandibular mobility exercises masticatory muscle self-massage as well as recommendations and advice on its pathology Data will be collected again 4 weeks after the end of the program and at months 6 and 12 The appearance of adverse effects linked to the therapeutic program is not contemplated
Detailed Description:
Study design Analytical prospective experimental study uncontrolled clinical trial
Population and study sample The study sample will be made up of subjects diagnosed with fibromyalgia who present with local myalgia myofascial pain or referred myofascial pain in the temporomandibular region according to the diagnostic criteria DCTMD The subjects will be recruited after the mandatory acceptance and authorization by the corresponding bodies during a recruitment period of approximately eight weeks through different associations of fibromyalgia patients
Intervention In a first visit demographic data will be recorded and an examination will be performed to assess the presence of local myalgia myofascial pain or referred myofascial pain in the temporomandibular region according to the diagnostic criteria DCTMD You will also be given to read and sign the informed consent for participation in the study as well as the data protection document After this visit the defined eligibility criteria inclusion and exclusion will be applied
In a second visit a preliminary assessment will be carried out that will consist of mandibular function pain level quality of life related to oral health kinesiophobia anxiety and depression sleep patient oral habits catastrophizing knowledge about pain central sensitization self-efficacy coping with pain patient expectations and patient satisfaction with the treatment received
One week later the intervention program will begin The program will consist of 3 online sessions visits 3 4 and 5 in which everything related to pain and its management will be explained In a first workshop a first educational session on the neurophysiology of pain will be given by means of a Power point presentation In a second workshop a tool will be used to locate those factors that can improveworse the pain physical documentation will be delivered with instructions for performing a self-massage and exercises of the temporomandibular region as well as advice and recommendations to manage different situations that may appear on a daily basis and on Lifestyle A meditation session will also be held In the third and last workshop the game the painometer will be played and a meditation session will be held
On a sixth visit 4 weeks after the end of the program a new measurement and assessment will be taken This measurement will be very similar to the one performed on the second visit except for 1 variable the patients expectations will not be recorded and the patients satisfaction with the treatment received will be recorded The objective will be to record the changes produced after the application of the treatment program
On a seventh visit at 6 months medium-term follow-up all the measurements and assessments made on the sixth visit will be repeated with the aim of recording their status after six months
At an eighth visit at 12 months long-term follow-up all the measurements and assessments made at the seventh visit will be repeated with the aim of recording their status after twelve months
Population and study sample The study sample will be made up of subjects diagnosed with fibromyalgia who present with local myalgia myofascial pain or referred myofascial pain in the temporomandibular region according to the diagnostic criteria DCTMD The subjects will be recruited after the mandatory acceptance and authorization by the corresponding bodies during a recruitment period of approximately eight weeks through different associations of fibromyalgia patients
Intervention In a first visit demographic data will be recorded and an examination will be performed to assess the presence of local myalgia myofascial pain or referred myofascial pain in the temporomandibular region according to the diagnostic criteria DCTMD You will also be given to read and sign the informed consent for participation in the study as well as the data protection document After this visit the defined eligibility criteria inclusion and exclusion will be applied
In a second visit a preliminary assessment will be carried out that will consist of mandibular function pain level quality of life related to oral health kinesiophobia anxiety and depression sleep patient oral habits catastrophizing knowledge about pain central sensitization self-efficacy coping with pain patient expectations and patient satisfaction with the treatment received
One week later the intervention program will begin The program will consist of 3 online sessions visits 3 4 and 5 in which everything related to pain and its management will be explained In a first workshop a first educational session on the neurophysiology of pain will be given by means of a Power point presentation In a second workshop a tool will be used to locate those factors that can improveworse the pain physical documentation will be delivered with instructions for performing a self-massage and exercises of the temporomandibular region as well as advice and recommendations to manage different situations that may appear on a daily basis and on Lifestyle A meditation session will also be held In the third and last workshop the game the painometer will be played and a meditation session will be held
On a sixth visit 4 weeks after the end of the program a new measurement and assessment will be taken This measurement will be very similar to the one performed on the second visit except for 1 variable the patients expectations will not be recorded and the patients satisfaction with the treatment received will be recorded The objective will be to record the changes produced after the application of the treatment program
On a seventh visit at 6 months medium-term follow-up all the measurements and assessments made on the sixth visit will be repeated with the aim of recording their status after six months
At an eighth visit at 12 months long-term follow-up all the measurements and assessments made at the seventh visit will be repeated with the aim of recording their status after twelve months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None