Shoe inserts for midfoot osteoarthritis pai

Not Applicable

Recruiting

Conditions: Osteoarthritis of the midfoot joints
Musculoskeletal - Osteoarthritis

Registration Number: ACTRN12623000953639

Lead Sponsor: a Trobe University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain in the midfoot whilst walking in the last 7 days, scored using an 11-point numerical rating scale (NRS) with terminal descriptors of 0 (no pain”) and 10 (worst pain imaginable”).[ Assessed at baseline and at 4, 8 and 12 weeks. 12 weeks is the primary end-point.]

Secondary Outcome Measures