We will investigate whether wearing the insoles can cause a reduction in the hallux valgus angle and the angle intermetatarsaal angle. Furthermore, we investigate the possible decrease in pain and improvement in functional score.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of the magnitude of the hallux valgus angle.
Secondary outcome
1. Can wearing "Step Forward Orthotics" orthotics for one year in people with
mild and moderate Hallux valgus provide a reduction in pain?
2. If the participants who have been using the insoles for one year can choose
again would they choose the insole of a surgery?
3. Are the function scores and quality of life improved with the use of these
insoles (measured over the time)?
4. Does the intermetatarsaal angle (IMA) become smaller after one year?
5. Are the measurements of the hallux valgus angle (HR) on the x-rays similar
to the blueprint results and digital photos? The blueprint results and digital
photos are used in the office. We want to know whether they are reliable enough
to be used in the future to measure the HR.
6. What is the minimal Important change?
7. What is the "smallest detectable change (SDC) in the measurement of the HV
and IMA, ie what is the meaurement error?
Background summary
Hallux valgus is a common foot problem, which is often accompanied by pain at
the art. 1st metatarsophalangeal. This can lead to limitations in activities
and participation and an increased risk of falling.When the Hallux Valgus is
combined with pain and limitations, this often leads to surgery. Recently,
there is some evidence that wearing a particular insole ("Step Forward
Orthotics") could reduce the hallux valgus angle.
Study objective
We will investigate whether wearing the insoles can cause a reduction in the
hallux valgus angle and the angle intermetatarsaal angle. Furthermore, we
investigate the possible decrease in pain and improvement in functional score.
Study design
prospective cohort study
Study burden and risks
During this study, the test subjects are exposed to a low dose of X-rays. Two
x-rays of the feet aremade. All data is coded. Participants will receive the
normal treatment with the additional X-rays and an online questionnaire. When
wearing the insoles your feet can feel sore and tired at the beginning.
A possible benefit is the decrease of Hallux valgus angle by using these
insoles.
Sportlaan 600
Den Haag 2566 MJ
NL
Sportlaan 600
Den Haag 2566 MJ
NL
Listed location countries
Age
Inclusion criteria
-Patienten die zich aanmelden voor een Step Forward Orthotics steunzool
- Age between 18-70 years.
- Hallux Valgus (HV) has an angle of a mild-to-moderate HV <25 ° (radiographic angle between the longitudinal axis of MT 1 and the longitudinal axis of the base phalanx)
- The minimal pain score (NRS) is scored on a 2 last week.
Exclusion criteria
-Patients who sign up for a Step Forward Orthotics insole
- HV rigidus (total range of motion (dorsiflexion + plantar) of less than 50 º)
- Diabetes mellitus,
- HV operation in history
- neuropathy
- poliomyelitis
- rheumatoid arthritis
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NL57888.098.16 |