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Comparison between Pneumatic Radial Shock Wave and Electromagnetic Radial Shock Wave on Pain and Disability Index in Patients with Plantar Fasciitis.

Protocol summary

Study aim
Comparison between Pneumatic Radial Shock Wave and Electromagnetic Radial Shock Wave on Pain and Disability Index in Patients with Plantar Fasciitis.
Design
A Quasi-experimental trials with 2 treatment groups with sample size including 36 patients and single blind. Patients through Random Table Number are divided by 2 groups. In the studied patients, special group sequentially enter in the dark envelopes. The envelopes is opened by researcher and patient is not aware of the treatment groups.
Settings and conduct
A study is conducted at the Khatam Al Anbia Physiotherapy Clinic.The patients with having inclusion criteria after referring to the clinic, randomly divided into Pneumatic Radial Shock Wave and Electromagnetic Radial Shock Wave. After completing the consent form and the initial assessment, the patients based on their group, will receive 5 treatment sessions. The Participants are blind to the treatment groups but researcher that is an evaluator is not blind to the treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women and men 23 to 61 years with Plantar Fasciitis with symptons at least 3 months; Exclusion criteria: bilateral Plantar Fasciitis, Arthritis: Ankylosing Spondylitis, Diabetes, Cardiac Arrhythmia or Pacemake, Vascular Disease, History of trauma or foot fracture, Infection or open wound on the heel, Radiculopathy, Neuropathy, Tarsal Tunnel Syndrome, Anticoagulant Therapy, History of fascia surgery, Malignancy, Pregnancy, History of Physiotherapy at 3 months ago, History of injection at 6 months ago, History of treatment with Shock Wave, Foot or Ankle, Athletes
Intervention groups
For the patients in the first group, 5 sessions treatments with Pneumatic Radial Shock Wave and in the second group, 5 sessions treatments with Electromagnetic Radial Shock Wave are used.
Main outcome variables
Pain; Disability Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180924041111N1
Registration date: 2018-10-21, 1397/07/29
Registration timing: registered_while_recruiting

Last update: 2018-10-21, 1397/07/29
Update count: 0
Registration date
2018-10-21, 1397/07/29
Registrant information
Name
Elham Rahbaran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3224 3803
Email address
rahbaran_elhamm@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Pneumatic Radial Shock Wave and Electromagnetic Radial Shock Wave on Pain and Disability Index in Patients with Plantar Fasciitis.
Public title
Comparison between Pneumatic Radial Shock Wave and Electromagnetic Radial Shock Wave on Pain and Disability in Patients with Plantar Fasciitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women and Men 23 to 61years with Plantar Fasciitis Symptoms for at least 3 months
Exclusion criteria:
Bilateral Plantar Fasciitis Arthritis: Ankylosing Spondylitis Diabetes Cardiac Arrhythmia or Pacemaker Vascular Disease Infection or Open Wound on the heel Radiculopathy, Neuropathy and Tarsal Tunnel Syndrome Anticoagulant Therapy Pregnancy History of recent Fascia Surgery History of Physiotherapy at 3 months ago Injection at 6 months ago History of treatment with Shock Wave Malignancy Athletes History of recent trauma or Foot fracture foot or ankle instability
Age
From 23 years old to 61 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization through Random Table Numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
After referring to the clinic, a person receives a consent form containing all information related to the purpose and benefits of study and all exclusion and inclusion criteria, which gives patient the right to participate in the study and assures her of retaining all her personal information and give her the right to leave the study if she wishes.The cause of single blindness of the study is that the participants are unaware of the treatment groups but the researcher that is an evaluator, is aware of the treatment groups.
Placebo
Not 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
Room 209, 2nd Floor, Building number 4, Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.MUI.REC.1396.3.307

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 and 1and 5 weeks after the intervention
Method of measurement
Visual Analogue Scale

2

Description
Disability Index
Timepoint
Before and 1and 5 weeks after the intervention
Method of measurement
foot and ankle ability measure questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1:for the one group, 5 sessions treatments with Pneumatic Radial Shock Wave, 360G, Novin are used.The treatment protocol including:1500 shocks, 1.5 bar at the first session and 2000 shocks, 2 bar at the second session and 2500 shocks, 3bar at the 3 last session
Category
Rehabilitation

2

Description
Intervention group 2: for the second group, 5 sessions treatments with electromagnetic Radial Shock Wave enPULS PRO, Zimmer are used.The treatment protocol including:1500 shocks, 1.5 bar at the first session and 2000 shocks, 2 bar at the second session and 2500 shocks, 3bar at the 3 last session
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
khatam Al Anbia
Full name of responsible person
Navid Taheri
Street address
1st floor, 2nd Jahan Soltan Bldg, Motasham Kashani St, Hakim Nezami Ave
City
Isfahan
Province
Isfehan
Postal code
8175979663
Phone
+98 31 3131 3551
Email
n_taheri@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
87746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
Ph.D., Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
sfahan University Of Medical Sciences, Hezarjerib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5043
Email
n_taheri@rehab.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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