The general aim of this project is to determine the (cost-)effectiveness of footwear modification in addition to GP-led usual care, compared to GP-led usual care alone for patients with first MTP joint osteoarthritis (OA) at 6 months of follow-up…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>Walking pain (11-point NRS) at 6 months follow-up<br />
Quality-Adjusted Life-Years (EQ-5D) at 6 months follow-up<br />
Societal costs over 6 months, using iMCQ and iPCQ questionnaires </p>
Secondary outcome
<p>Self-reported recovery (GROC), foot function (FHSQ) and PASS at 6 and 12 months<br />
follow-up*<br />
Barriers and facilitators of patients and health care professionals for the<br />
implementation of the intervention in general practice</p>
Background summary
OA is a chronic condition characterized by pain and impaired function.
Symptomatic radiographic OA of the foot affects 16.7% of people aged over 50
years and the most affected joint in the foot is the first metatarsophalangeal
(MTP-1) joint. Symptomatic MTP-1 OA is highly disabling and has a significant
impact on quality of life. Non-surgical and non-pharmacological interventions
are in general recommended as first line treatment for OA. Though, specific
guidelines for the non-surgical management of foot OA are lacking as only few
randomized trials have been conducted. Only one pilot study has so far compared
a footwear intervention with usual general practice care. This study was
however not powered to investigate the effectives of treatment. Another RCT
(N=100) compared shoe stiffening to a sham shoe insert and concluded that the
intervention was more effective at reducing foot pain than sham inserts at 12
weeks follow-up with a NNT of 4. There is therefore urgency to study the
cost-effectiveness of this frequently applied intervention in near future.
Study objective
The general aim of this project is to determine the (cost-)effectiveness of
footwear modification in addition to GP-led usual care, compared to GP-led
usual care alone for patients with first MTP joint osteoarthritis (OA) at 6
months of follow-up.**
Study design
Randomized clinical trial
Intervention
Patients randomized to the intervention group will, in addition to usual GP
care, be referred to an orthopedic shoemaker. The intervention is defined as OVAC, which stands for footwear modification of ready-made footwear (confection shoes), including the following options, depending on patient needs: sole-stiffening and support, sole and heel modifications to enhance heel-toe-gait and arch-support.
Study burden and risks
The burden to participants of the intervention; the time spent to complete the
online questionnaires (5x around 60 minutes, 8x around 5 minutes),
meetings (minimal 2) with a local orthopedic shoemaker (incl traveling)
as per standard of care;
The burden to participants of part 2; the time spent for the interview (max. 30
minutes)
The benefit is that participants of the intervention will probably receive the
treatment (footwear modification) earlier that in the standard of care (wait
and see) and might not need surgery in the (next) future.
M van Middelkoop
Dr. Molewaterplein 40
Rotterdam 3015 GD
Netherlands
0107030004
kwaliteithag@erasmusmc.nl
M van Middelkoop
Dr. Molewaterplein 40
Rotterdam 3015 GD
Netherlands
0107030004
kwaliteithag@erasmusmc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- aged 45 years or older
- able to walk with or without assistance devices
- proficient in Dutch language
- confirmed diagnosis of MTP-1 joint OA by a health care professional.
- pain in the foot needs to be present on most days of last month and
- either no morning joint-related stiffness or
- morning stiffness that lasts no longer than 30 minutes
Exclusion criteria
- Patients that have already received footwear modifications or custom- made orthopedic shoes in the past.
- Patients that have undergone surgery as treatment for MTP-1 osteoarthritis.
- Patients that are contraindicative to receive an OVAC, because they use a splint or brace, or because their feet will not fit in an OVAC because of other foot problems.
- Patients that are insured with ASR, DSW, ENO or Menzis, which require a secondary care specialist to provide referral for the OVAC.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 | NL87646.078.24 |
| Research portal | NL-005193 |