To determine the contribution of musculoskeletal pain to activity limitations corrected for the impact biomechanical factors (joint biomechanics, proprioception, physical fitness) and psychological comorbidity. The secondary objective is to identify…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes will be set at the amount of activity impairment.
Secondary outcome
Secondary outcomes will entail potential contributing factors for activity
impairment in terms of Musculoskeletal complaints (pain and fatigue), physical
factors (Joint biomechanics, muscle power, proprioception) and psychological
factors (psychological comorbidity and parental factors).
Background summary
Musculoskeletal pain is the primary feature of children diagnosed with
Hypermobility Syndrome (HMS) and Ehlers Danlos hypermobility type (EDS-HT). In
addition a high prevalence of (chronic) fatigue, psychological distress and
deconditioning have been reported in literature. As a result these children are
often mild to severely impaired in activities, leading to chronic disability
and social restrictions in early childhood to even more extensively in later
stages of life. The most striking clinical characteristic of HMS/EDS-HT is the
presence of an excessive range of joint motion, also known as Generalized Joint
Hypermobility (GJH), which is hypothesized to be causative for the development
of musculoskeletal pain and functional decline. However GJH is also common
within normal child populations and only 1% to 3% will develop HMS/EDS-HT, and
musculoskeletal pain is only episodically and does not become chronic. Till
present day no pathophysiological has been identified as well as factors that
may underlie functional decline.
Study objective
To determine the contribution of musculoskeletal pain to activity limitations
corrected for the impact biomechanical factors (joint biomechanics,
proprioception, physical fitness) and psychological comorbidity. The secondary
objective is to identify discriminative factors between children with
HMS/EDS-HT and GJH in order to develop patient risk profiles for HMS/EDS-HT.
Study design
The study has a cross-sectional design. A multi-level factorial analysis will
be performed, according to mixed linear models, on the association of activity
impairments with Musculoskeletal pain. Due to the number of included outcomes
data reduction will be performed by discriminative analysis. Factors that are
discriminative between groups (healthy controls without GJH, healthy children
with GJH and HMS/EDS-HT) will form the basis of the associative models, in
order to determine the relevance of these factors to activity impairment.
Study burden and risks
The participants are required to one visit to the rehabilitation department of
the AMC. All procedures are part of the clinical routine and have been found
safe. However the measurements can be exhausting and the questions in the
questionnaire can concern intimate information.
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 Az
NL
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 Az
NL
Listed location countries
Age
Inclusion criteria
Inclusion will be based on one of the following diagnoses:;Hypermobility Syndrome: according to the Brighton criteria
Ehlers Danlos (hypermobility type): Villefranche criteria
Generalized Joint Hypermobility: Beighton score >4
Exclusion criteria
Primary exclusion criteria encompass the presence of other heritable disorders of connective tissue (HDCT) like Ehlers-Danlos (other than the hypermobile type), Marfan syndrome or osteogenesis imperfecta. If genetic screening rules out HDCT*s, the participant is again eligible for inclusion in the study.;Secondary exclusion criteria encompass:
-A history of surgery is present on the extremities, spine or thorax that could interfere with walking, or with arm/hand function related activities.
-Any conditions that render the participant too unfit to be tested (such as pulmonary and/or cardiac disorders)
-Any conditions that render the participant unable to understand or adhere to the protocol (such as cognitive, social, visual and/or language problems, or hand problems, that render the patient unfit to fill-in the questionnaires).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51223.018.15 |