The main objective of this study is to evaluate the effect of the dynamic shoulder orthosis on the shoulder pain and glenohumeral subluxation.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are: (1) the shoulder pain scores before and during
the intervention, and (2) the acromiohumeral distance without and with
orthosis.
Secondary outcome
The secondary study parameters are: pain-free range of motion, arm activity,
shoulder function, device usage and user satisfaction
Background summary
Shoulder subluxation is a partial separation of the humeral head and the
glenoid. Shoulder supports, also known as braces or orthoses, are frequently
prescribed to patients with glenohumeral subluxation (GHS). Clinical objectives
for prescribing a shoulder brace include, among others, a reduction of stress
in the passive structures from gravitational pull during standing or walking,
maintenance of a proper glenohumeral alignment and shoulder pain reduction. A
dynamic shoulder subluxation orthosis has been developed to reduce the stress
on the soft tissue around the shoulder complex without limiting the retaining
range of motion of the arm, such that shoulder pain is reduced and the
functional recovery of patients with remaining arm function is not inhibited.
Study objective
The main objective of this study is to evaluate the effect of the dynamic
shoulder orthosis on the shoulder pain and glenohumeral subluxation.
Study design
Interventional study
Intervention
The study population is provided a shoulder orthosis for the duration of two
weeks. In the week before the orthosis fitting, the population will not use any
intervention.
Study burden and risks
Participants have to visit the University of Twente once for the intermediate
assessment session. The other assessment sessions will be conducted at the
patient*s home. During each assessment session, multiple outcome measures are
collected. During the first week of the study, the patient will not receive any
intervention. During the second and third week of the study, the patient will
use a customized shoulder orthosis that can provide an upward force to the arm
to reduce the gravitational pull of the arm weight on the shoulder. Risks
associated with the use of the device are limited, as the patient is in full
control of the magnitude of the force provided by the mechanism to the arm.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
- >= 18 years
- Suspicion of subluxation of the glenohumeral joint
- Chronic shoulder pain (> 6 months)
- Having given written informed consent prior to undertaking any study-related
procedures
Exclusion criteria
- Unable to understand and follow simple verbal commands
- Inability to sit upright in a chair without arm supports for at least 15
minutes consecutively
- Inability to let the affected arm unsupported for one week
- Irritated skin in the application area of the orthosis
- Recent shoulder or arm operation (<6 months before participation in the
study)
Design
Recruitment
Medical products/devices used
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 | NL74819.091.20 |