Objective: to compare the clinical effectiveness of local corticosteroid injection with shock wave for plantar fascitis.
Inclusion criteria: more than 18 years of age; a history of heel pain for at least four weeks unresponsive to conservative treatments; pain with the intensity of more than 2 in a 100 mm visual analog scale at the baseline; tenderness at the medial plantar calcaneal region
Exclusion criteria: evidence of calcaneal fracture on x-ray; history of heel surgery; damage to Achilles tendon; inflammatory diseases; diabetes mellitus; local or systemic infections; peripheral vascular diseases; gout; blood coagulation disorders; corticosteroid injection during the last 6 months; contraindications to steroid; non-steroidal anti-inflammatory use within the last 7 days
Participants: overall, 74 patients are randomly allocated equally to two groups.
Primary outcome: pain intensity at the standing position
Secondary outcomes: early morning pain; pain on joint movement, daily activities, climbing stairs and exercise tolerance. The outcomes are evaluated repeatedly up to 3 months after interventions.
Interventions: in the group corticosteroid, a single dose of 40 mg methylprednisolone acetate (0.5 ml) mixed with 2 ml of 2% lidocaine is injected. For the group shock wave three doses of 2000 pulses of energy with 10 Hz frequency and 2.5 bar pressure with the intervals of one week are applied.
Randomization and blinding: a computer-generated randomization list of 74 items in blocks of variable sizes is used. We had two groups of 37 participants each. The clinical assessor will be blinded to the baseline evaluations and to the administered treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030616865N1
Registration date:2014-05-19, 1393/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-19, 1393/02/29
Registrant information
Name
Mahsa Asheghan
Name of organization / entity
Baqiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 8837
Email address
m_asheghan@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of shock wave versus corticosteroid for pain reduction in plantar fasciitis: randomized clinical trial
Public title
A comparison of shock wave versus corticosteroid for pain reduction in plantar fasciitis: randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: more than 18 years of age; a history of heel pain for at least four weeks unresponsive to conservative treatments (NSAIDS); pain with the intensity of more than 2 in a 100 mm visual analog scale (VAS) at the baseline visit; tenderness at the medial plantar calcaneal region
Exclusion criteria: evidence of calcaneal fracture on x-ray; history of heel surgery; damage to Achilles tendon; inflammatory diseases like rheumatoid arthritis; diabetes mellitus; local or systemic infections; peripheral vascular diseases; gout; blood coagulation disorders; corticosteroid injection during the last 6 months; contraindications to steroid injection; non-steroidal anti-inflammatory use within the last 7 days; Pregnant or breast feeding mothers
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Chamran highway
City
Tehran
Postal code
14455364
Approval date
2011-01-01, 1389/10/11
Ethics committee reference number
1032
Health conditions studied
1
Description of health condition studied
Plantar fascial fibromatosis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascitiis
Primary outcomes
1
Description
Pain intensity at the standing position
Timepoint
All the outcomes were evaluated at the baseline visit and at 1 week, 1 month, and 3 months after the intervention.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Early morning pain; pain on joint movement; daily activities; climbing stairs and exercise tolerance
Timepoint
All the outcomes were evaluated at the baseline visit and at 1 week, 1 month, and 3 months after the intervention.
Method of measurement
Visual analog scale. We also assess the ability to perform daily activities, climbing stairs and exercise tolerance with visual analog scale for foot and ankle (VASFA). Patients state their levels of functionality with matching it to the numbers 0 (unable to do) to 100 (without any difficulty).
Intervention groups
1
Description
For the group shock wave three doses of 2000 pulses of energy with 10 Hz frequency and 2.5 bar pressure with the intervals of one week are applied.
Category
Treatment - Drugs
2
Description
In the group corticosteroid, a single dose of 40 mg methylprednisolone acetate (0.5 ml) mixed with 2 ml of 2% lidocaine is injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Kamran Azma
Street address
Etemad Zadeh alley, Western Fatemi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Mollasadra street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan, MD
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Mollasadra street
City
Tehran
Postal code
1436913511
Phone
+98 212188058837
Fax
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan, MD
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Mollasadra street
City
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Fax
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan, MD
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Mollasadra street
City
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Fax
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)