The aim of this randomised crossover trial is to compare the Manometric TMC brace with conventional plaster braces in terms of patient satisfaction, pain, hand function, compliance and patient preference.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction, the primary outcome, is measured using the validated
Dutch version of the Quebec User Evaluation of Satisfaction with Assistive
Technology (D-QUEST). Since no literature is published yet about the minimally
clinically important difference for the D-QUEST, we defined a value for
ourselves. A difference in score on the D-QUEST of more than 10%, this means
0.5 point difference on the 5-point outcome score, was considered to be the
margin of clinical significance in this study.
Secondary outcome
Secondary outcomes includes pain, measured by a 10-cm visual analogue scale
(VAS), and hand function, measured in terms of grip and pinch strength. In
addition, hand function and symptoms are assessed using the Dutch version of
the QuickDASH. Compliance is quantified by the wearing time per day in hours,
reported using a self-reported diary of each patient. At the end of the two
treatment periods, patient preference for one of the two braces is asked.
Background summary
Osteoarthritis (OA) is a degenerative joint disease. The trapeziometacarpal
(TMC) joint is the carpometacarpal joint of the thumb. OA in the TMC joint is a
common disease with a prevalence of 30% to 40% for postmenopausal women.
One of the conservative treatments for TMC OA is a TMC brace. Evidence showed
that TMC braces can reduce pain in TMC OA. Plaster braces are the current
conventional treatment of TMC OA in the Reinier de Graaf hospital. Recently,
Manometric developed a 3D printed custom-made brace, based on a 3D scan of the
patient's* hand. It is made out of light materials and options for
personalisation are provided.
(for references, refer to the research protocol introduction, page 10 and
references, page 39))
Study objective
The aim of this randomised crossover trial is to compare the Manometric TMC
brace with conventional plaster braces in terms of patient satisfaction, pain,
hand function, compliance and patient preference.
Study design
Randomised crossover trial with two 4-week treatment periods and 1-week
wash-out period in between.
Intervention
Patients will wear both the Manometric brace and the plaster brace for four
weeks. A washout period of 1 week is between the treatment periods.
Study burden and risks
After risk analysis, it can be concluded that there are minimal risks for
participating patients. Participating in this study requires extra appointments
in the hospital.
Reinier de Graafweg 5
Delft 2625 AD
NL
Reinier de Graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
- Clinical and radiological diagnosis osteoarthritis (OA) in the TMC joint
- OA grade 1, 2 or 3 (according to the Kellgren-Lawrence classification system)
- Age *18
- Signed informed consent
- Sufficiently able to understand Dutch, In case of bilateral TMC OA, patients
who only need a brace for one hand are included, or if they are willing to wait
till after the study for a brace for their second hand. The most symptomatic
side is included in the study, based on clinical and radiological assessment.
Exclusion criteria
- Disease in the affected hand or wrist other than TMC OA that may interfere
with treatment or bias the study outcome (OA in radiocarpal joints, underlying
inflammatory rheumatic disease, neurovascular disorder affecting the upper
limb, fracture in the past 6 months, significant hand injuries)
- Other (current) therapy for TMC OA (corticosteroid injection in the past 6
months, surgery in the affected TMC joint)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL67750.098.18 |