Musculoskeletal Nociceptive Pain in Participants With Neuromuscular Disorders

CompletedOBSERVATIONAL
Enrollment

82

Participants

Timeline

Start Date

April 15, 2021

Primary Completion Date

August 15, 2022

Study Completion Date

August 15, 2022

Conditions
Pompe Disease (Late-onset)Myotonic Dystrophy Type 1 (DM1)Myotonic Dystrophy Type 2Spinal Muscular Atrophy Type 3Inclusion Body Myositis, SporadicFacioscapulohumeral Muscular Dystrophy 1Healthy
Interventions
DIAGNOSTIC_TEST

Beck depression inventory fast screen

Beck depression inventory fast screen questionnaire to detect severe depression for eligibility.

DIAGNOSTIC_TEST

German Pain Inventory

German Pain Inventory questionnaire for evaluation of pain. Module A, abbreviated questions of module S (sociodemographic questions S1, S2, S3, S4, S5 and S8) and module L (quality of life) and V (therapies) will be used.

DIAGNOSTIC_TEST

Brief Pain Inventory

Validated questionnaire for pain.

DIAGNOSTIC_TEST

Fatigue Severity and Disability Scale (FSS)

Validated questionnaire for perceived fatigue

DIAGNOSTIC_TEST

Quick Motor Function Test

An evaluator observes the performance of a patient and scores the items separately on a 5-point ordinal scale (ranging from 0 to 4). A total score is obtained by adding the scores of all items and ranges between 0 and 64 points.

DIAGNOSTIC_TEST

Handheld Dynamometry (HHD)

To ensure a high level of objective measurement, muscle strength will also be assessed by handheld dynamometry. The following muscle groups will be tested: Arm abduction, elbow flexion, elbow extension, hip flexion, hip extension, knee extension, knee flexion, foot extension, foot flexion.

DIAGNOSTIC_TEST

Six-minute walk test (6MWT)

It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

DIAGNOSTIC_TEST

Pressure pain threshold

"For diagnosis of myofascial pain, pressure algometers are designed and conventionally used to measure deep pressure pain thresholds or tenderness resistance (Park, Kim et al. 2011), and the reliability of pressure pain thresholds according to raters or measurement frequencies has been proven to be relatively high (Chung, Um et al. 1992). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The measurement will be stopped immediately as the patient feels sensations of burning, stinging, drilling or aching. Pressure algometry measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles."

DIAGNOSTIC_TEST

Myotonometer Assessment

Muscle stiffness, muscle tone, relaxation periods and viscoelasticity will be assessed by a myotonometer of selected muscles (non-invasive measurement). The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.

DIAGNOSTIC_TEST

Vital signs

Vital signs (blood pressure, heart rate, respiratory rate) will be measured before and after the six-Minute-Walk-Test (6MWT).

DIAGNOSTIC_TEST

Borg Scale

the Borg scale will be assessed, which is a self-reported questionnaire designed to subjectively assess dyspnea and exertion during activity (Borg 1982). The Borg scale rates dyspnea on a scale of 0 to 10 incorporating nonlinear spacing of verbal descriptors of the level of intensity of dyspnea. A higher Borg score indicates more severe dyspnea. The Borg scale will be administered before starting the 6MWT (≤ 5 minutes) and after completing the 6MWT (≤ 5 minutes).

Trial Locations (1)

80336

Friedrich-Baur-Institute, München

All Listed Sponsors
lead

LMU Klinikum

OTHER