None listed
Conditions
Brief summary
The purpose of this ‘proof of concept’ study is to investigate a multi-faceted podiatry intervention in people with symptomatic first metatarsophalangeal joint osteoarthritis. Specific aims are: 1. To determine the feasibility, safety and perceived patient response to a multi-faceted podiatry intervention in people with first metatarsophalangeal joint osteoarthritis. 2. To investigate the efficacy of a multi-faceted podiatry intervention on pain and self-reported function compared to usual care in people with first metatarsophalangeal joint osteoarthritis. People with first metatarsophalangeal joint osteoarthritis will receive either the podiatry intervention or usual care of analgesia and advice, and feasibility data, as well as changes in pain and function will be assessed after 12 weeks.
Interventions
A 12 week multi-faceted podiatry treatment consisting of foot orthotics; foot and ankle exercises performed both in the clinic and on a daily basis at home; and education and advice concerning appropriate footwear, analgesia, weight management and general physical activity. These are explained in more detail below:
Foot orthotics: prefabricated device with (a) a first ray cut out unless pain is exacerbated, or (b) a morton's extension if pain is exacerbated with the cut out. People with a FPI s
A 12 week multi-faceted podiatry treatment consisting of foot orthotics; foot and ankle exercises performed both in the clinic and on a daily basis at home; and education and advice concerning appropriate footwear, analgesia, weight management and general physical activity. These are explained in more detail below: Foot orthotics: prefabricated device with (a) a first ray cut out unless pain is exacerbated, or (b) a morton's extension if pain is exacerbated with the cut out. People with a FPI score >7 will also have a varus wedge added. After a familiarisation period, participants will be advised to wear their orthotics as much as possible each day, however at a minimmum, they will be advised to wear them for at least 6 hours every day. Exercises: Performed twice daily for an approximate duration of 20 minutes each, and including (a) Isometric flexor hallucis strengthening (push toe in to ground) performed 10 x 10 seconds, (b) mobilisation performed by first metatarsophalangeal joint distraction (one minute) and glides (one minute), (c) plantar foot massage using a ball for 5 minutes Advice delivered by the podiatrist during each participant's initial clinical visit (approx 10 minutes). This will include advice on analgesia (a maximum of 4 g/day of paracetamol if needed), weight management (general advice and dietitian referral if needed) and physical activity (30 minutes on most days) will be provided and reinforced with an Arthritis Australia booklet). Treatment adherence will be self-assessed in a log book and participants will be sent reminder emails by a research assistant.
Sponsors
Kade Paterson
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
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants aged over 40 with symptomatic radiographic first metatarsophalangeal joint osteoarthritis. First metatarsophalangeal joint osteoarthritis will be defined as radiographic osteoarthritis (established using a valid and reliable atlas) and corresponding self-reported pain of >40mm on a 100mm visual analogue scale in the past four weeks in one or both of the first metatarsophalangeal joints.
Exclusion criteria
The main exclusion criteria are: (i) inflammatory or systemic arthritis or other condition affecting lower limb function, (ii) use of foot orthotics or intra-articular foot injections in the past six months (iii) previous musculoskeletal foot surgery; (iv) grade 3 or 4 hallux valgus; (v) currently receiving treatment for their first metatarsophalangeal joint osteoarthritis pain; (vi) medial knee OA or pain; and (vii) pain in any other location that is worse that their first metatarsophalangeal joint osteoarthritis pain.
Outcome results
None listed