None listed
Conditions
Brief summary
Our primary aim is to compare the effectiveness of ultrasound-guided corticosteroid injections to foot orthoses (shoe insoles) for individuals with plantar heel pain, using an assessor-blinded randomised trial. Our hypothesis is that corticosteroid injections will be more effective in the short-term (0-4 weeks), while foot orthoses will be more effective in the longer term (5-12 weeks). Our secondary aims are to compare the effectiveness of corticosteroid injections to foot orthoses on: foot function; general health; plantar fascia thickness; work, sport and recreation; and fear-avoidance beliefs.
Interventions
A single corticosteroid injection.
1 mL betamethasone (Celestone Chondrose) mixed with 1 mL bupivacaine (Marcaine 0.5%) injected perifascially by a radiologist under ultrasound guidance. As this is a single injection, adherence will be monitored by attendance at the appointment with the radiologist, Adverse events associated with this intervention will be documented.
In addition, participants will perform plantar fascia and calf stretches prior to standing each morning, by holding the stretch
A single corticosteroid injection. 1 mL betamethasone (Celestone Chondrose) mixed with 1 mL bupivacaine (Marcaine 0.5%) injected perifascially by a radiologist under ultrasound guidance. As this is a single injection, adherence will be monitored by attendance at the appointment with the radiologist, Adverse events associated with this intervention will be documented. In addition, participants will perform plantar fascia and calf stretches prior to standing each morning, by holding the stretch for a period of 10 seconds, repeated 10 times for each foot/leg (total daily stretch session of approximately 7 to 8 minutes each morning for 12 weeks). Adherence will be monitored by recording the number of days per week the participant has performed their stretches, assessed via questionnaire at each four-weekly timepoint.
Sponsors
Glen Whittaker
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (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) Have a clinical diagnosis of PHP in accordance with the clinical practice guidelines linked to the International Classification of Function, Disability and Health from the Orthopaedic Section of the American Physical Therapy Association, which includes: a. Pain the plantar medial heel region that is aggravated by weightbearing activities or worse in the morning and/or after a period of rest b. Pain upon palpation of them medial calcaneal tubercle (iii) A duration of PHP for at least 4 weeks (iv) Report their average pain over the last seven days as at least 30 mm on a 100 mm visual analogue scale (v) Be willing to regularly wear foot orthoses for the duration of the trial (vi) Be willing and have no contraindications to receive a corticosteroid injection in the plantar heel (vii) Be willing not to implement any other forms of treatment during the trial (with the exception of paracetamol 4g/day)
Exclusion criteria
(i) Unable to understand the English language (ii) Unable to walk household distances unaided (iii) Have received treatment for PHP in the last four weeks (iv) Have received a corticosteroid injection in the previous six months (v) Have a history of surgery to the heel (vi) Have a systemic medical condition such as a connective tissue disease, degenerative neurological disorder or inflammatory disorder (vii) Unwilling to wear footwear that can accommodate foot orthoses (viii) Have regularly worn foot orthoses within the previous six months
Outcome results
None listed