None listed
Conditions
Brief summary
The primary aim of this project is to evaluate the efficacy of shoe inserts in the treatment of pain associated with osteoarthritis of the midfoot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 12 week follow-up. One-hundred and forty participants will be randomised to receive one of two types of shoe inserts. All participants will receive clinical guideline-based information and support. Primary and secondary outcome measures will be collected at baseline and at 4, 8 and 12 weeks. The primary outcome measure will be the severity of average pain in the midfoot whilst walking in the last 7 days, scored using an 11-point numerical rating scale (NRS). Secondary outcome measures will include function, self-reported global rate of change, level of physical activity, general health-related quality of life, use of co-interventions and adverse events.
Interventions
Prefabricated foot orthoses (Formthotics™ manufactured by Foot Science International, Christchurch, New Zealand).
Each participant will receive two pairs of foot orthoses to be fitted in the shoes they wear most regularly. The foot orthoses will be full-length arch contouring devices, manufactured from a single-density polyethylene closed cell foam that will support the arch of the foot. The foot orthoses will be fitted by a registered Podiatrist and will be modified with the addition of a 4°
Prefabricated foot orthoses (Formthotics™ manufactured by Foot Science International, Christchurch, New Zealand). Each participant will receive two pairs of foot orthoses to be fitted in the shoes they wear most regularly. The foot orthoses will be full-length arch contouring devices, manufactured from a single-density polyethylene closed cell foam that will support the arch of the foot. The foot orthoses will be fitted by a registered Podiatrist and will be modified with the addition of a 4° medium density varus wedge if the Foot Posture Index is >7. They will then be heated and placed in the participant’s footwear. The participant will be required to stand in their footwear with the heated foot orthoses to enable the devices to mould to their feet. This is standard clinical care using this intervention. Participants will be advised to use the foot orthoses in their footwear for as much time as they can during the day, for the 12 weeks of the trial. Adherence will be monitored by recording the average days per week, plus the average number of hours per day the participant has worn the foot orthoses, assessed via online questionnaires at each four-weekly timepoint. Clinical guideline-based information and support: both groups will receive a standardised education package derived from clinical guidelines for management of osteoarthritis regarding midfoot osteoarthritis, osteoarthritis flares, advice around exercise such as activity modification, weight loss, the use of topical non-steroidal anti-inflammatory drugs (NSAIDs), and footwear advice.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) Aged 18 years and over (ii) Pain in the midfoot joints that has been present for at least 3 months, located in at least one area in a predetermined dorsal midfoot region, that is aggravated by weightbearing activities (iii) Average pain in the midfoot when walking during the last 7 days is rated at least 3 out of 10 in severity on an 11-point numerical rating scale (NRS) (where 0 represents "no pain" and 10 represents the "worst pain imaginable") (iv) Have radiographic evidence of midfoot osteoarthritis confirmed using the La Trobe University Atlas of foot osteoarthritis – a minimum score of 1 for either observations of joint space narrowing or osteophytes in at least one of the midfoot joints in either radiographic view (v) Able to walk household distances (>50 metres) without walking aids (vi) Willing to regularly wear shoes that will accommodate shoe inserts (vii) Willing to attempt to not receive additional interventions during the study period
Exclusion criteria
(i) Previous ipsilateral foot surgery or planning surgery in the next 12 weeks (ii) Osteoarthritis secondary to other issues such as major trauma (iii) Presence of other foot or ankle condition(s) or have pain in another location that is greater than the pain in the midfoot (iv) Any musculoskeletal or systemic medical conditions (e.g., suspected inflammatory joint disease, neurological) that could make the participant unsuitable for inclusion or confound pain and functional assessments of the midfoot (v) Any inability to speak and read English (vi) Any treatment that includes the use of any foot orthoses (including shock absorption shoe inserts), ankle braces and/ or, received intra-articular injections at the midfoot in the previous 12 weeks (vii) Dementia or any cognitive impairment
Outcome results
None listed