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Status:

COMPLETED

Musculoskeletal Nociceptive Pain in Participants With Neuromuscular Disorders

Lead Sponsor:

LMU Klinikum

Conditions:

Pompe Disease (Late-onset)

Myotonic Dystrophy Type 1 (DM1)

Eligibility:

All Genders

18+ years

Brief Summary

The primary aim is to characterize the prevalence, severity and quality of musculoskeletal nociceptive pain in adult patients with neuromuscular disorders (NMD). The secondary objectives are to evalua...

Detailed Description

The explorative, cross-sectional low-interventional pilot study evaluates the prevalence, severity and quality of musculoskeletal nociceptive pain in participants with defined neuromuscular disorders ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • The participant is willing and able to provide signed informed consent.
  • The participant is able and willing to perform study-related assessments.
  • The participant is ≥18 years of age
  • The participant has one of the following diagnoses:
  • histologically confirmed inclusion body myositis (IBM), or
  • genetically confirmed late-onset Pompe disease (LOPD), or
  • genetically confirmed spinal muscular atrophy type 3 (SMA3), or
  • genetically confirmed myotonic dystrophy type 1, or
  • genetically confirmed myotonic dystrophy type 2, or
  • genetically confirmed facio-scapulo-humeral muscle dystrophy (FSHD).
  • Exclusion Criteria
  • The participant is participating in another clinical study or using an investigational treatment.
  • The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
  • The participant has currently a severe depression, assessed by the Beck depression inventory fast screen (BDI-FS) with a score ≥ 4

Exclusion

    Key Trial Info

    Start Date :

    April 15 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 15 2022

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT04907162

    Start Date

    April 15 2021

    End Date

    August 15 2022

    Last Update

    August 24 2022

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Friedrich-Baur-Institute

    München, Bavaria, Germany, 80336