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Musculoskeletal complaints in patient with congenital disorders of the hand and arm.


- candidate number28373
- NTR NumberNTR6940
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2017
- Secondary IDs2017/481 METc UMCG
- Public TitleMusculoskeletal complaints in patient with congenital disorders of the hand and arm.
- Scientific TitleMusculoskeletal complaints in congenital anomalies of the upper extremity.
- ACRONYMnone
- hypothesisPatients with a congenital anomaly are more likely to develop musculoskeletal complaints compared to healthy individuals.
- Healt Condition(s) or Problem(s) studiedCongenital anomalies, Upper extremity, Skeletal muscle, Pain, Adults, Upper Extremity Deformities, Congenital
- Inclusion criteria• Patients and healthy subjects aged 18 years or older.
• Sufficient knowledge of the Dutch language to fill out the questionnaire
• A large congenital anomaly of the upper extremity classified by the “OMT CLASSIFICATION OF CONGENITAL HAND AND UPPER LIMB ANOMALIES” as follows:
I. MALFORMATIONS
A. Abnormal axis formation/differentiation—entire upper limb
1. Proximal-distal axis
i…Brachymelia with brachydactyly
ii..Symbrachydactyly
a) Poland syndrome
iv. Intersegmental deficiency
a) Proximal (humeral – rhizomelic)
b) Distal (forearm – mesomelic)
c) Total (Phocomelia)
v. Whole limb duplication/triplication
2. Radial-ulnar (anterior-posterior) axis
i…..Radial longitudinal deficiency - Thumb hypoplasia (with proximal limb involvement)
ii….Ulnar longitudinal deficiency
iii...Ulnar dimelia
iv...Radioulnar synostosis
v….Congenital dislocation of the radial head
vi…Humeroradial synostosis - Elbow ankyloses
vii..Madelung deformity
3. Dorsal-ventral axis
i…..Ventral dimelia
a) Furhmann/Al-Awadi/Raas-Rothschild syndromes
b) Nail Patella syndrome
ii….Absent/hypoplastic extensor/flexor muscles
4. Unspecified axis
i…..Shoulder
a) Undescended (Sprengel)
b) Abnormal shoulder muscles
c) Not otherwise specified
ii…..Arthrogryposis

B. Abnormal axis formation/differentiation— hand plate
1. Proximal-distal axis
i…..Brachydactyly (no forearm/arm involvement)
ii….Symbrachydactyly (no forearm/arm involvement)
2. Radial-ulnar (anterior-posterior) axis
i…..Radial deficiency (thumb - no forearm/arm involvement)
ii....Ulnar deficiency (no forearm/arm involvement)
v….Ulnar dimelia (mirror hand – no forearm/arm involvement)
3. Dorsal-ventral axis
i…..Dorsal dimelia (palmar nail)
ii….Ventral (palmar) dimelia (including hypoplastic/aplastic nail)
4. Unspecified axis
i…..Soft tissue
d) Distal arthrogryposis
iii. Complex
a) Complex syndactyly
b) Synpolydactyly— central
c) Cleft hand
d) Apert hand
e) Not otherwise specified

II. DEFORMATIONS
C. Not otherwise specified

III. DYSPLASIAS
A. Hypertrophy
1. Whole limb
i…..Hemihypertrophy
ii….Aberrant flexor/extensor/intrinsic muscle
2. Partial limb
i…..Macrodactyly
ii….Aberrant intrinsic muscles of hand
- Exclusion criteria• Comorbidity severely affecting upper extremity function
• Amputation of the upper extremity
• Transverse reduction defects of the upper extremity classified by the “OMT CLASSIFICATION OF CONGENITAL HAND AND UPPER LIMB ANOMALIES” as follows:
I. MALFORMATIONS
A. Abnormal axis formation/differentiation—entire upper limb
1. Proximal-distal axis
b) Whole limb excluding Poland syndrome
iii. Transverse deficiency
a) Amelia
b) Clavicular/scapular
c) Humeral (above elbow)
d) Forearm (below elbow)
e) Wrist (carpals absent/at level of proximal carpals/at level of distal carpals ) (with forearm/arm involvement)
f) Metacarpal (with forearm/arm involvement)
g) Phalangeal (proximal/middle/distal) (with forearm/arm involvement)
B. Abnormal axis formation/differentiation— hand plate
1. Proximal-distal axis
iii…Transverse deficiency (no forearm/arm involvement)
a) Wrist (carpals absent/at level of proximal carpals/at level of distal carpals)
b) Metacarpal
c) Phalangeal (proximal/middle/distal)
II. DEFORMATIONS
A. Constriction ring sequence

• ‘Minor’ congenital anomalies classified by the “OMT CLASSIFICATION OF CONGENITAL HAND AND UPPER LIMB ANOMALIES” as follows:
B. Abnormal axis formation/differentiation— hand plate
2. Radial-ulnar (anterior-posterior) axis
iii…Radial polydactyly
iv…Triphalangeal thumb
vi…Ulnar polydactyly
4. Unspecified axis
i…..Soft tissue
a) Syndactyly
b) Camptodactyly
c) Thumb in palm deformity
ii. Skeletal deficiency
a) Clinodactyly
b) Kirner’s deformity
c) Synostosis/symphalangism (carpal/metacarpal/phalangeal)
II. DEFORMATIONS
B. Trigger digits
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jun-2020
- Target number of participants200
- InterventionsNone
- Primary outcomePatient reported musculoskeletal complaints
Pain reported on visual analog scale.
Items on pain in SF-36 questionnaire.
- Secondary outcomeReported upper extremity function
UEWD-R questionnaire
PDI questionnaire
DASH questionnaire
- TimepointsOne timepoint: the filling out of the questionnaire.
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIES MJJ Koenis
- CONTACT for SCIENTIFIC QUERIES MJJ Koenis
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Beatrixoord Noord Nederland
- PublicationsNone yet
- Brief summaryThe objective of this study is to determine the prevalence of musculoskeletal complaints in congenital anomalies of the upper extremity compared to healthy subjects. Its design is a cross-sectional study using a postal survey. Seven rehabilitation centers in the Netherlands will hopefully contribute; UMCG, Revalidatie Friesland, De Vogellanden, Sint Maartenskliniek, Adelante Limburg, De Hoogstraat Revalidatie, Rijndam Revalidatie.
The following outcomes will be measured: self-reported function and disability of the upper extremity; self-reported prevalence of musculoskeletal complaints and related disability; general and mental health perception; questionnaires (subscales) in Dutch: DASH (Disabilities of the Arm, Shoulder and Hand), Pain Disability Index, RAND-36.
- Main changes (audit trail)
- RECORD22-dec-2017 - 18-jan-2018


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