Protocol summary

Summary
The aim of this study is to compare effect of dry needling and extra corporeal shock wave therapy on plantar fasciitis.All patients with plantar fasciitis, who are unresponsive to usual treatment are included in the study.Patients with inflammatory disease history ,trauma ,local injection ,achill bursitis ,active radiculopathy are excluded from the study . 72 patients with plantar Fasciitis are classified randomly in the two groups of dry needling treatment and shock therapy (each group involving 36 members). Dry needling is conducted for 1-3 sessions and extra corporeal shock wave therapy is conducted for three sessions . both treatment groups are evaluated before intervention and after four and eight weeks, respectively. Primary outcome of the study will be pain reduction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610014104N6
Registration date: 2016-10-23, 1395/08/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Mohammad Rahbar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1544 6694
Email address
rahbarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the Dry Needle on Plantar Fasciitis in Compared to Extracorporeal Shock Wave Therapy (ESWT)
Public title
The Effect of the Dry Needle on heel spur in Compared to Extracorporeal Shock Wave Therapy (ESWT)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All patient with Plantar Fasciitis؛ without responses to usual medical ؛ treatment after one moon . Exclusion Criteria: inflammatory disease such as (RA)؛ history of trauma ؛ history of local injection or PT in tree moons ago ؛ heel pain associated with Achill bursitis ؛ active S1 radiculopathy
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Street address
University Avenue, campus
City
tabriz
Postal code
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
IR.TBZMED.REC.1395.562

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
Daily pain intensity
Timepoint
Before treatment and 4 and 8 weeks after treatment
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
The rate of recovery
Timepoint
Before treatment and 4 and 8 weeks after treatment
Method of measurement
Foot Function Index - Visual Analog Scale

Intervention groups

1

Description
Dry needling
Category
Rehabilitation

2

Description
extrcorporeal shock wave therpy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals Imam Reza , Madani And Shohada
Full name of responsible person
Ali Kargar
Street address
Shayan Mehr Pansion , Resalat Avenu , Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicine Research Center
Full name of responsible person
Dr Dolatkhah
Street address
Imam Reza Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Ali kargar
Position
Rezident Rehabilitation
Other areas of specialty/work
Street address
ImamReza
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
alikargar114348@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical University ofTabriz
Full name of responsible person
Mohammad Rahbar
Position
Assistant of Professor
Other areas of specialty/work
Street address
ImamReza
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
Rahbar63@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Resident of Rehabilitation
Full name of responsible person
Ali Kargar
Position
Medical University of Tabriz
Other areas of specialty/work
Street address
Imam Reza
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
alikargar114348@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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