Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04907162 |
Other study ID # |
PainNMD Version 1 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 15, 2021 |
Est. completion date |
August 15, 2022 |
Study information
Verified date |
August 2022 |
Source |
LMU Klinikum |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 evaluate whether severity and distribution of muscle pain is associated
with muscle function, and to assess whether muscle pain is associated with alterations of
muscle elasticity and muscle stiffness. Results of patients with neuromuscular disorders will
be compared to age- and gender-matched healthy volunteers. Approx. 70 patients with
neuromuscular disorders and 20 healthy volunteers will be enrolled, including patients with
the following neuromuscular disorders: histologically confirmed inclusion body myositis
(IBM), genetically confirmed late-onset Pompe disease (LOPD), genetically confirmed spinal
muscular atrophy type 3 (SMA3), genetically confirmed facio-scapulo-humeral muscle dystrophy
(FSHD), genetically confirmed myotonic dystrophy type 1 or type 2 (DM1, DM2). The duration of
patient recruitment will be around 12 months.
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 (NMD). Adult participants with the following neuromuscular disorders
will be included: histologically confirmed inclusion body myositis (IBM), genetically
confirmed late-onset Pompe disease (LOPD), genetically confirmed spinal muscular atrophy type
3 (SMA3), genetically confirmed facio-scapulo-humeral muscle dystrophy (FSHD) and genetically
confirmed myotonic dystrophy type 1 or type 2 (DM1, DM2). 20 healthy participants will be
enrolled as a control group. The Beck depression inventory fast screen (BDI-FS) will be used
as a screening. If there is a possibility of major depression (with a BDI ≥4), patients will
be excluded from the study. So only patients with BDI-FS score ≤3 at screening will be
enrolled. Patients will be asked to complete the following validated disease-related and
quality-of-life questionnaires: German Pain Inventory (module A and abbreviated module S and
L and V), Brief Pain Inventory (BPI) and Fatigue Severity and Disability Scale (FSS).
Demographic and disease related data will be obtained. A neuromuscular examination will be
conducted. A clinical evaluation of muscle strength using the MRC-Scale (Medical Research
Council-Scale) will be performed on both sides deltoid muscles, biceps brachii muscles,
triceps brachii muscles, hip flexors, hip extensors, quadriceps femoris muscles, foot
extensor and foot flexor muscles as well as axial muscles and neck flexors and extensors. The
Quick Motor Function Test (QMFT) with 16 items will be performed to assess muscle and
movement functions of the participants. To ensure a high level of objective measurement,
muscle strength will also be assessed by using 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. A six-minute-walk test
(6MWT) will be performed once. Additionally, first signs of muscle pain or muscle cramps will
be recorded (including the quality and intensity of pain). The Borg scale to rate dyspnea
will be administered before starting the 6MWT and after completing the 6MWT. For diagnosis of
myofascial pain, a Pressure Pain Threshold test by using a pressure algometer is included for
the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the
tibialis anterior muscles until the patient feels any sensation of pain. Measurement of
muscle stiffness, muscle tone, relaxation periods and viscoelasticity of selected muscles
will be assessed by a myotonometer. Data collected in this study will be reported using
summary tables, figures, and patient data listings. Differences between the patients and the
healthy volunteers will be analyzed.