Comparison of therapeutic responses of corticosteroid injection vs Extra-corporeal shock-wave treatment in patients with acute plantar fasciitis referred to Rasht Poursina hospital
(1) Objectives: This study seeks to evaluate therapeutic responses of these methods in patients with acute plantar fasciitis. (2) Design: Randomized clinical trial. (3) Setting and conduct: after randomization using random block system, in control group, 1 c.c of "Methyl-prednisolone acetate" 40 milligrams plus 1 c.c of "lidocaine" 2% will be injected in maximal point tenderness of inferomedial aspect of calcaneal tuberosity. For all intervention group patients, three sessions of shock-wave with 1500-2000 frequency and energy density of 0.15 mJ/mm2 with 1 week interval (total energy flux density dose: 900 mJ/mm2) will be performed. (4) Participants including major eligibility criteria: All patients> 18 years old with clinical acute plantar fasciitis diagnosis; Severe morning calcaneal pain which ameliorates after walking; Point tenderness on calcaneal tuberosity. Exclusion criteria: History of rheumatoid arthritis; Psycho-social problems; Diabetes mellitus; History of local injection and physiotherapy; any bony lesion including fractures or tumors. (5) Intervention: Intervention group: Corticosteroid injection, Control group: intermediate Extra-corporeal Shock-wave treatment (ESWT) (6) Main outcome measures: Measuring alteration of pain recorded in VAS score
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108097274N1
Registration date:2011-08-28, 1390/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-28, 1390/06/06
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic responses of corticosteroid injection vs Extra-corporeal shock-wave treatment in patients with acute plantar fasciitis referred to Rasht Poursina hospital
Public title
Comparison of therapeutic responses of corticosteroid injection vs ultrasound in patients with plantar fasciitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with plantar fasciitis or calcaneal spur diagnosis refered to orthopedic clinic of Poursina Hospital in Rasht; Severe morning calcaneal pain which ameliorates after walking; Point tenderness on calcaneal tuberosity.
Exclusion criteria: History of rheumatoid arthritis; Psycho-social problems; Diabetes mellitus; History of local injection and physiotherapy; Any bony lesion including fractures or tumors.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue
City
Rasht
Postal code
Approval date
2011-07-20, 1390/04/29
Ethics committee reference number
1900189603
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis Plantar fasciitis
Primary outcomes
1
Description
Therapeutic response (Rate of pain reduction)
Timepoint
Pre-treatment, 3, 6 and 12 weeks post-treatment
Method of measurement
VAS score
Secondary outcomes
1
Description
Recurrence rate
Timepoint
Recurrence rate
Method of measurement
VAS score
Intervention groups
1
Description
For all intervention group patients, three sessions of shock-wave with 1500-2000 frequency and energy density of 0.15 mJ/mm2 with 1 week interval (total energy flux density dose: 900 mJ/mm2) will be performed
Category
Treatment - Devices
2
Description
The orthopedist needles and injects mixture of 1cc of Methyl Prednisolon Acetate (40mg) and 1cc of 2% Lidocaine at maximal point tenderness from inferomedial aspect of calcaneal tuberosity in control group.