Myalgias in myopathies: severity, consequences and type of muscle pain
Organizational Data
- DRKS-ID:
- DRKS00033329
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2024-01-02
- Last update in DRKS:
- 2024-02-09
- Registration type:
- Prospective
Acronym/abbreviation of the study
Myalgia in myopathies
URL of the study
No Entry
Brief summary in lay language
Muscle diseases (myopathies) have a varied clinical appearance and can manifest themselves in different age groups. A distinction is made between inflammatory and congenital myopathies. What these diseases have in common is a reduction in muscle strength and varying degrees of muscle pain (myalgia). As part of this study, patients are asked about the presence of myalgias using a detailed questionnaire. In particular, the frequency, severity and exact character of the pain will be assessed using a study-specific questionnaire and two other questionnaires established in everyday clinical practice (Pain Detect and Widespread Pain Index). The necessity and frequency of taking medication for pain therapy and the perception of non-medication therapy methods are also surveyed. In addition, the diagnosis and key disease data, such as duration of illness and severity of physical limitations, as well as secondary diagnoses are recorded on the basis of the patient file. The aim of this study is to characterize the pain character, severity, pain frequency and distribution of myalgias of the different myopathies. In addition, it will be examined whether conclusions can be drawn about the disease subgroup on the basis of the pain and it will be shown which patient groups are particularly affected by myalgias. By investigating these important aspects, the need for pain medical care for patients with neuromuscular diseases is to be determined.
Brief summary in scientific language
Myopathies (primary muscle diseases) comprise a heterogeneous spectrum of hereditary and acquired diseases, the main common symptoms of which are a reduction in muscle strength and muscle atrophy. In addition to paresis and reduced muscle mass, associated with everyday limitations and immobility, other symptoms such as swallowing disorders, sensory deficits and muscle pain (myalgia) can also occur, which can seriously impair the quality of life of those affected. The quality, localization, frequency and severity of the muscle pain as well as influencing external factors (e.g. physical activity, temperature) can diverge significantly between different muscle diseases and provide clinical indications of the disease entity. As part of this study, patients are asked about the presence of myalgia using a detailed questionnaire. In particular, the frequency, severity and exact character of the pain will be assessed using a study-specific questionnaire and two other questionnaires established in everyday clinical practice (Pain Detect and Widespread Pain Index). The necessity and frequency of taking medication for pain therapy and the perception of non-medication therapy methods are also surveyed. In addition, the diagnosis and basic disease data, such as duration of illness and severity of physical limitations, as well as secondary diagnoses are recorded on the basis of the patient file. The aim of this study is to characterize the pain character, severity, pain frequency and distribution of myalgias of the different myopathies. In addition, it will be examined whether conclusions can be drawn about the disease subgroup based on the pain and it will be shown which patient groups are particularly affected by myalgia. By surveying these important aspects, the need for pain medical care for patients with neuromuscular diseases is to be determined. Myalgias are a relevant symptom in both acquired and hereditary myopathies. However, idiopathic inflammatory myopathies play a prominent role here, as myalgias have been identified as a key domain in terms of symptom burden and relevance to everyday life in myositis, particularly from the perspective of those affected. The lack of sufficient symptom control and uniform treatment recommendations highlights the need for improved characterization of the pain profile in different disease entities in the spectrum of primary muscle diseases. Based on this data collection, particularly vulnerable subgroups with an accumulation of myalgias can be identified, treatment strategies and behavioural recommendations can be derived and healthcare staff (e.g. doctors, nursing staff and therapists) can be sensitized to patients at risk. These findings are also particularly relevant because multiple therapeutic options are available for patients with myalgia, which can be made accessible to those affected.
Health condition or problem studied
- ICD10:
- G71.0 - Muscular dystrophy
- ICD10:
- G71.1 - Myotonic disorders
- ICD10:
- G71.2 - Congenital myopathies
- ICD10:
- G71.3 - Mitochondrial myopathy, not elsewhere classified
- ICD10:
- M33.1 - Other dermatomyositis
- ICD10:
- M33.2 - Polymyositis
- ICD10:
- M33.9 - Dermatopolymyositis, unspecified
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- If the patient consents, he/she will be asked to complete a study-specific questionnaire regarding myalgia. This questionnaire asks about the severity and frequency of the myalgia, the type of pain and its consequences, as well as the treatment of the pain and its effectiveness. In addition, the quality of the pain is assessed using other questionnaires that were not developed specifically for the study (Pain Detect Questionnaire, Widespread Pain Index (WPI)), but are routinely used in everyday clinical practice. The strength levels and the usual clinical neurological examination are determined. Further information regarding the underlying disease (duration of illness, clinical course, results of instrumental diagnostics, most recent laboratory results (creatine kinase, CRP), drug therapy for the underlying disease) is collected from the medical records. In addition, general data such as gender, age and secondary diagnoses (in particular joint arthrosis, osteoporosis and spinal syndromes) are also recorded using the electronic patient file. There is no study-related pain therapy or treatment.
Endpoints
- Primary outcome:
- Recording the frequency and severity of myalgias in patients with myopathies
- Secondary outcome:
- Type of muscle pain (sharp, dull, etc.). Differences in myalgias between inflammatory and hereditary myopathies. Effectiveness of the different pain therapies. Characterization of the pain features of the various myopathies.
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Göttingen Göttingen
Recruitment period and number of participants
- Planned study start date:
- 2024-01-05
- Actual study start date:
- 2024-01-05
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Patient with clinically and instrumentally confirmed myopathy - ≥ 18 years of age - Ability to give consent
Exclusion Criteria
- Patient without or with unclear neuromuscular disease without certain classification of the disease - <18 years - Patient unable to give consent
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin Göttingen, Klinik für Neurologie37075 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin Göttingen, Klinik für NeurologieJana ZschüntzschRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- +49 551 3965683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsmedizin Göttingen, Klinik für NeurologieJana ZschüntzschRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- +49 551 3965683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsmedizin Göttingen, Klinik für NeurologieJana ZschüntzschRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- +49 551 3965683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin Göttingen, Klinik für Neurologie37075 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umg.eu/ueber-uns/vorstand/kommissionen/ethikkommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-11-20
- Ethics committee number:
- 18/12/23
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry