Orthoses or Flip-Flops for Pain in the Heel: a randomised clinical trial

Not Applicable

Recruiting

• Conditions: Heel pain; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12612000463875
• Lead Sponsor: Professor Bill Vicenzino

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

i. Report of (insidious non-traumatic onset) plantar heel pain for at least 1 month.
ii. First step pain in the morning of at least a 3/10 on a Pain Numerical Rating Scale.
iii. English communication skills to adequately understand questionnaires, allow valid treatment (orthoses) and outcome measurements to be performed
iv. Adequate shoes into which the active comparator can be fitted
v. Willingness to wear flip-flop or orthosis regularly for the 12 weeks duration of the trial

Exclusion Criteria

i. History of previous therapy treatment of plantar fasciitis within the past month
ii. History or diagnosis of circulatory conditions
iii. Pregnancy
iv. Foot pathologies (including diabetes, gout, amputation, nerve impingement, tarsal tunnel syndrome, tumours, stress fracture, autoimmune disease, pitting oedema, lower extremity referred pain, previous plantar fascia surgical procedures, corticosteroid injections) within the past 12 months (for the transient conditions or treatments)
v. Participation in athletic activity 5 or more days per week for more than 90 minutes for day
vi. Other orthopaedic or neurological impairment that prevents a symmetrical walking pattern or an antalgic gait that was not attributed to plantar heel pain

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
15 point Global Rating of Change Scale: participants are asked to rate if they are better, same or worse, and if better or worse by how much on a 5 point scale (hence 15 points, 7 worse, 1 same and 7 better). This is a commonly used rating of change scale in clinical trials.[0, 4 and 12 weeks];Lower Extremity Function Scale: Is a 20 item scale in which the participant rates the degree of difficulty (extreme to no difficulty over 0 to 4 points) on common weight bearing activities.[0, 4 and 12 weeks]