purpose of the study: The effectiveness of shock wave therapy combined with topical corticosteroid in improvement of plantar fasciitis.
inclusion criteria :Age>18 y; Disease duration more than 6 months; Not responsive to conservative treatment.
Exclusion Criteria:Age less than 18; pregnancy; bone tumor; open wound; Received topical corticosteroid within the last 6 weeks; Active infection; Skin disease; peripheral neuropathy; Past history of surgery in this region; vascular disease.
A randomized clinical trail; double blind study. sample size: 40 patients referring to Physical Medicine Clinics of Isfahan University of Medical Sciences
intervention: shock wave therapy weekly for 4 weeks for both groups and 30 min before shock wave session, Clobetasol ointment for interventional group and Vaseline oil for control group.
Primary outcomes are reduction in pain measured with VAS and modified Roles and Maudsley score. Secondary outcome is plantar fascia thickness assessed by sonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081029296N1
Registration date:2016-09-16, 1395/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-16, 1395/06/26
Registrant information
Name
Arghavan Mokhtarian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 1811
Email address
a.mokhtarian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of shock wave therapy combined with topical corticosteroid in improvement of plantar fasciitis
Public title
A novel way in treatment of chronic plantar fasciitis: Combination of Extracorporeal shock wave therapy and topical corticosteroid with occlusive dressing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>18 y; Disease duration more than 6 months; Not responsive to conservative treatment; Exclusion criteria : Age less than 18 ;Open growth plate; pregnancy; bone tumor or other malignancy near treatment site; metabolic disease; open wound; Received systemic corticosteroid within the last month; Received topical corticosteroid in plantar fascia region within the last 6 weeks; Active infection; Skin disease; peripheral neuropathy; coagulopathy disorder; received heparin or warfarin; Past history of plantar ligament rupture; Past history of surgery in this region; vascular disease; Allergic reaction to sulfonamide, NSAID or Aspirin; Heart failure; tarsal tunnel syndrome
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Postal code
7346181746
Approval date
2016-01-09, 1394/10/19
Ethics committee reference number
IR.MUI.REC.1394.3.764
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
Pain
Timepoint
before intervention /1 month and 3 months after intervention
Method of measurement
Visual Analogue Scale
2
Description
Modified Roles and Maudsley score
Timepoint
before intervention /1 month and 3 months after intervention
Method of measurement
Modified Roles and Maudsley Scale
Secondary outcomes
1
Description
Plantar fascia thickness
Timepoint
before and 3 months after intervention
Method of measurement
sonography
Intervention groups
1
Description
Intervention group:
4 session of shock wave weekly and 30 minutes before each session Clobetazol oint with occlusive dressing on plantar region.
Focus-SW Shock :
2000 Energy: 0.2-0.3 Frequency :4Hz
Radial-SW Shock:
3000 Energy: 1.8-3 Frequency: 15Hz
Category
Treatment - Other
2
Description
Control group:
4 session of shock wave, weekly and 30 minutes before each session Vaseline oil with occlusive dressing on plantar region.
Focus-SW Shock :
2000 Energy: 0.2-0.3 Frequency :4Hz
Radial-SW Shock:
3000 Energy: 1.8-3 Frequency: 15Hz
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitaion Clinic of Alzahra Hospital
Full name of responsible person
Arghavan Mokhtarian
Street address
Soffeh Avenue
City
Isfahan
2
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinic of Kashani Hospital
Full name of responsible person
Arghavan Mokhtarian
Street address
Kashani Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mansour.Siavash
Street address
Vice Chancellor of Research, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Science
Full name of responsible person
Arghavan Mokhtarian
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation,Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
a.mokhtarian@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Babak Vahdat Pour
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
vahdatpour@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Arghavan mokhtarian
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation,Alzahra University Hospital, Soffeh Avenue
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
a.mokhtarian@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)