Objective: Evaluation the effect of dry needle on pain and the ankle sprain motion range and plantar fascia thickness changes in patients with Plantar Fasciitis.
Study design: Random (shuffle bags method), without placebo control, single central.
Experimental population: Patients with Plantar Fasciitis who referred to Neuromuscular Rehabilitation research center of Semnan University of medical sciences
Inclusion criteria: Patients with PFs in aged 40 to 60 years; having trigger point in gastro or soleus muscles or both of them; thickness plantar fascia more than 4 mm; foot pain in first steps in the morning and at least six months has passed since the onset of pain; the pain level in visual analog scale is at least four; non-athlete persons; plantar flexion or dorsi flexion is less than normal range.
Exclusion criteria: Diabetes; hypersensitivity to needle; fear of needle; pregnancy; infection; peripheral neuropathy; hemophilia or coagulation problems; history of plantar fascia surgery; history of injection in the last three months.
Sample size, intervention, intervention time and outcome of the study: Sample size of this study is 30 persons will be divided into intervention (15 persons) and control (15 persons) group.
Intervention group: Patients were undergoing to dry needle (according protocol). After dry needling for four weeks so once a week, examinations of the level of pain and range of motion and thickness plantar fascia will be performed. Also, one month after treatment, the variables will be measured again to follow up the treatment.
Control group: In the control group will not perform any treatments and it just to compare with intervention group for level of thickness plantar fascia, the level of pain and range of motion will be measured at the beginning of the study and one month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080525732N22
Registration date:2017-08-23, 1396/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-23, 1396/06/01
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling on pain and Range of Motion of ankle joint and thickness of plantar fascia in patient with plantar fasciitis
Public title
The effect of dry needling on pain and Range of Motion of ankle joint and thickness of plantar fascia in patient with plantar fasciitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with PFs in aged 40 to 60 years; having trigger point in gastro or soleus muscles or both of them; thickness plantar fascia more than 4 mm; foot pain in first steps in the morning and at least six months has passed since the onset of pain; the pain level in visual analog scale is at least four; non-athlete persons; plantar flexion or dorsi flexion is less than normal range.
Exclusion criteria: Diabetes; hypersensitivity to needle; fear of needle; pregnancy; infection; peripheral neuropathy; hemophilia or coagulation problems; history of plantar fascia surgery; history of injection in the last three months.
Age
From 40 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
semnan
Postal code
3514799442
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.semums.REC.1396.133
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fasciitis
Primary outcomes
1
Description
Plantar Fascia Thickness
Timepoint
Before and after using a dry needle
Method of measurement
Ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group will not perform any treatments and it just to compare with intervention group for level of thickness plantar fascia, the level of pain and range of motion will be measured at the beginning of the study and one month later.
Category
Rehabilitation
2
Description
Intervention group: Patients were undergoing to dry needle (according protocol). After dry needling for four weeks so once a week, examinations of the level of pain and range of motion and thickness plantar fascia will be performed. Also, one month after treatment, the variables will be measured again to follow up the treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Ziaeddin Safavi-Farokhi
Street address
Ghods Blvd, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi-Farokhi
Position
Physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)