The primary aim of the study is (i) to assess the effect of a soft brace on pain, knee stability and activity limitations. Secondary aims are (ii) to assess the difference in effect of two knee soft braces (i.e., non-tight and tight) on pain and…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Knee pain, self-reported and performance-based knee joint stability and
performance-based activity limitations (GUG, 10-m walk test).
Secondary outcome
Secondary study parameters are knee joint proprioception, skin sensitivity,
pressure pain, postural balance, compliance, adherence, and side effects.
Furthermore, socio-demographic variables (age, gender), comorbidity, body mass
index (BMI), muscle strength, and self-reported activity limitations (WOMAC).
Background summary
Knee osteoarthritis (OA) is characterized by pain, knee instability and
activity limitations. Knee bracing has been claimed as an option in the
management of knee OA. Evidence has been found that a soft brace may reduce
knee pain. The effect of a soft brace on knee pain has been attributed to the
stimulation of cutaneous sensory fibres from skin mechanoreceptors, which might
reduce knee instability. The effect of a soft brace on knee pain, knee
instability and activity limitations has not been replicated and the underlying
mechanisms are not clear.
Study objective
The primary aim of the study is (i) to assess the effect of a soft brace on
pain, knee stability and activity limitations. Secondary aims are (ii) to
assess the difference in effect of two knee soft braces (i.e., non-tight and
tight) on pain and activity limitations, (iii) to explore underlying mechanisms
of the therapeutic effect of a soft brace and (iv) to assess the late effects
of two weeks application of a soft brace on pain, knee stability and activity
limitations in patients with knee osteoarthritis (OA).
Study design
A within-subject longitudinal design, comparing no soft brace versus soft
brace, and comparing two types of soft braces: tight versus non-tight. The
order of application of tight and non-tight soft braces will be randomized.
After two weeks of wearing a soft brace late effects on pain, knee stability
and activity limitations will be assessed and the satisfaction of wearing a
soft brace will be reported.
Intervention
Soft knee braces will be used. Depending on the knee size, subjects will get a
different size of the soft brace: with a variety between small and large. These
different sizes will be used to differentiate between non-tight and tight soft
braces. A non-tight brace will be one size looser than the tight brace.
Study burden and risks
The risk of wearing a soft-brace on side effects is negligible. Total risk of
adverse events during the assessments and during walking on the treadmill is
also negligible. The risk on adverse events is negligible during the two weeks
of wearing the soft brace. When participants are satisfied in wearing the
soft-brace, they may keep them and wear them for a longer time.
De Boelelaan 1117
Amsterdam 1081 HZ
NL
De Boelelaan 1117
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
knee osteoarthritis based on the ACR criteria, age between the 50 and 80 years old, Body Mass Index (BMI) between 20 and 30 kg/m2, a maximal score of 7 on the numeric rate scale (NRS) for pain intensity during the past two weeks and having the perception of an episode of buckling, shifting or giving way of the knee in the past three months
Exclusion criteria
Total knee replacement, rheumatoid arthritis or any other form of inflammatory arthritis (i.e., crystal arthropathy or septic arthritis).
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 | NL51872.029.15 |