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 Neurologie
37075 Göttingen
Germany
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 Neurologie
Jana Zschüntzsch
Robert-Koch-Straße 40
37075 Göttingen
Germany
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 Neurologie
Jana Zschüntzsch
Robert-Koch-Straße 40
37075 Göttingen
Germany
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 Neurologie
Jana Zschüntzsch
Robert-Koch-Straße 40
37075 Göttingen
Germany
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 Neurologie
37075 Göttingen
Germany
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 Göttingen
Von-Siebold-Straße 3
37075 Göttingen
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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