We aimed to evaluate the effects of extracorporeal shock wave therapy (ESWT) on plantar fasciitis symptoms and ultrasonographic findings. In this randomized placebo-controlled trial, adult patients with plantar fasciitis who referred to our clinic from 2010 to 2011 with symptoms for at least three months and no satisfactory response to common treatments such as NSAIDs were included. Patients were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm2) in 3 sessions at weekly intervals or sham therapy (n = 20 in each group). Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients’ pain scores, performed at baseline and 12 weeks after completion of the therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072910439N1
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Babak Vahdatpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
vahdatpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Extracorporeal Shock Wave Therapy on Pain and Ultrasonographic Findings in Adult Patients with Plantar Fasciitis
Public title
Extracorporeal Shock Wave Therapy in Patients with Plantar Fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions criteria:
- Age 18 to 65 years
- Having plantar heel pain for at least three months and point tenderness at or near the medial calcaneal insertion of the plantar fascia,
- Have no satisfactory response to common treatments such as NSAIDs and physiotherapy
- Willing to participate
Exclusion criteria:
- Having diabetes, additional foot or ankle pathology (including instability, arthritis, generalized polyarthritis, diffuse heel pad tenderness), local dermatological problems, neurological abnormalities, history of recent trauma or foot surgery, connective tissue or infectious diseases, malignancy, or vasculitis,
- Pregnant patients,
- Those who received anticoagulant therapy in the preceding six months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Approval date
2011-01-09, 1389/10/19
Ethics committee reference number
389450
Health conditions studied
1
Description of health condition studied
Plantar Fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Plantar Fascia Thickness
Timepoint
Before and 12 weeks after therapy
Method of measurement
Ultrasonograpgy
Secondary outcomes
1
Description
Pain
Timepoint
Before and 12 weeks after therapy
Method of measurement
Numerical rating scale
Intervention groups
1
Description
Intervention:
ESWT by weekly interval for three consecutive weeks; 2000 focused shock waves and 2000 radial pulses in three sessions (4000 shock waves/session of 0.2 mJ/mm2) at weekly intervals.
Category
Treatment - Other
2
Description
Placebo:
Sham treatment was done where standard contact of radial and focus probe with the skin was avoided. The machine makes a noise with every shock wave delivered and, in order to enhance the sham design, minimal energy pulses (0.04mJ/mm2) were generated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Dr. Sepideh Sajadieh
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice CHancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
389450
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice CHancellor for Research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sepideh Sajadieh
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 31 1220 6221
Fax
Email
sepidehsajadieh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sepideh Sajadieh
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 31 1220 6221
Fax
Email
sepidehsajadieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Sepideh Sajadieh
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 31 1220 6221
Fax
Email
sepidehsajadieh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)