To test the hypothesis that patients who do understand the importance of tolerance of pain to regain motion after a radius fracture, do better than patients who don't understand, in terms of motion and DASH scores at follow-up. Secondarily, to…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rated agreement with "No pain, no gain" statement
Elbow function (degrees) for radial head fractures
Wrist Function (degrees) for distal radius fractures
Secondary outcome
DASH scores
CES-D scores
PCS scores
Background summary
Psychological and personality factors, such as pain anxiety, catastrophizing,
and depression are strongly related to upper extremity specific health status
and may also influence recovery. Fractures of the distal radius and radial
head often lead to limitation of function. We believe that subjects who
understand that tolerance of pain is necessary for good recovery from this
injury will do better, whereas subjects that fear pain and believe that they
are harming themselves when they do exercises that cause pain can develop
permanent stiffness.
Study objective
To test the hypothesis that patients who do understand the importance of
tolerance of pain to regain motion after a radius fracture, do better than
patients who don't understand, in terms of motion and DASH scores at
follow-up.
Secondarily, to evaluate the influence of psychosocial factors and cultural
difference on both objective (motion, grip strength) and subjective (DASH
questionnaire) measures of functional recovery.
Study design
All subjects that fit inclusion and exclusion criteria will be invited to
enroll. The treating physician/investigator will inform patients about the
study during initial visit at the outpatient clinic. The study will be
described in detail and informed consent will be obtained by the research
fellow during the next follow-up visit. It will be emphasized that
participation is voluntary.
Subjects will be asked to fill out questionnaires (DASH, CES-D, DLV-IV) and get
a physical examination at their standard follow-up appointment with the
treating surgeon (distal radius: at 6 and 12 weeks, radial head: at 4 weeks).
In addition, subjects will be asked to rate their agreement with the following
statement with respect to recovery from their injury: *No pain, no gain*, with
use of a 5-point Likert scale.
Study burden and risks
Subjects may be bothered by having to complete questionnaires. Some of the
questions on the psychological questionnaires may make subjects feel
uncomfortable. Subjects will not be obligated to answer and psychological or
psychiatric counseling will be available to subjects if necessary. Little
benefit is expected to participating individuals. Rather the benefit will be to
society, as this research will better define the role of cultural differences
and attitude toward pain in the rehabilitation after a radial head or distal
radius fracture.
Meibergdreef 9
1100 DD Amsterdam
Nederland
Meibergdreef 9
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. A non-operatively treated fracture of the radial head or distal radius.
2. Cognitive and physical ability to do exercises.
3. Isolated injury
4. Dutch resident
5. Age > 18 years
Exclusion criteria
1. pregnant women
2. patients that are unable to give informed consent
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 | NL15255.018.06 |