Investigating the immediate and delayed effect of Quadratus plantae muscle dry needling on pain and plantar fascia thickness in patients with plantar heel pain. Determining the immediate and delayed effect of dry needling on variables and comparing them between the two groups of study.
Design
A randomized clinical trial study with two parallel group including control and intervention groups, single-blind on 40 patients. Randomization will be done simply by selecting a closed envelope by every patient.
Settings and conduct
This study is performed with the voluntary participations with plantar fasciitis at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. Both groups of study are taught stretch and massage of plantar fascia. The intervention group is also treated by Quadratus plantae dry needling for two weeks, twice a week. In the control group, the intensity of pain and the plantar fascia thickness are measured in the first and last session. In the intervention group, the variables are measured before and after the first and last session. Two weeks after the intervention, the variables will be compared between two groups. Data analyzer is blind.
Participants/Inclusion and exclusion criteria
Patients with plantar fasciitis who are over 18 years of age and plantar fascia thickness should be more than 4 mm. There should be first step pain in the morning and at least one month has passed since the onset of pain. The intensity of pain should be at least 4 based on VAS scale.
Intervention groups
Both group of study will be taught stretch and massage of plantar fascia. The intervention group, in addition, undergoes Quadratus plantae dry needling treatment.
Main outcome variables
Plantar fascia thickness,
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027562N10
Registration date:2020-11-28, 1399/09/08
Registration timing:prospective
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Roghayeh Mohammadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
mohammadipt@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Quadratus Plantae Muscle Dry Needling on Pain and Plantar Fascia Thickness in Patients with Plantar Heel Pain
Public title
Effect of Dry Needling in plantar fascia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with plantar fasciitis
Plantar fascia thickness more than 4 millimeter
Fist step pain
At least one month has passed since the onset of pain
Intensity of pain should be at least 4 based on the VAS scale
Exclusion criteria:
History of diabetes, rheumatology and cardiovascular diseases
Fear of needle
Pregnancy
Myofascial trigger points and muscle shortness in Hamstring and Gastrocnemius muscles
Infection, neuropathy and coagulation problems
History of injection in the last 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple and individually. In order to make a random selection, the closed envelope will be selected by the patient himself/herself. If the envelope contains the letter A, the person will be included in the control group's list, and if the letter B is displayed, the person will be placed in the intervention group. This method continues until the number of people in both groups reaches the quorum.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the data analyzer, the data is encoded to the analyzer. Therefore, the analyzer will not be able to distinguish the data of the participants of the two groups from each other.
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
Province
Semnan
Postal code
3514799442
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.SEMUMS.REC.1399.244
Health conditions studied
1
Description of health condition studied
Plantar fascitiis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Plantar fascia thickness
Timepoint
Fist and last sessions for control group, before and after first and last sessions for intervention group
Method of measurement
Ultrasound imaging
Secondary outcomes
1
Description
Pain
Timepoint
First and last sessions for control group, before and after first and last sessions for intervention group
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Control group: Plantar fascia thickness and intensity of pain are measured in the first session. Stretch and massage of plantar fascia are taught to the control group to perform for two weeks. After two weeks, the thickness of the plantar fascia and the intensity of pain are measured again.
Category
Rehabilitation
2
Description
Intervention group: Stretch and massage of plantar fascia are taught to this group to perform for two weeks. The group also receives Quadratus plantae dry needling treatment. Dry needling is applied to the trigger points of muscle. The plantar fascia thickness and the intensity of pain are measured before and after the first session. Dry needling will be done twice a week for two weeks. plantar fascia thickness and the intensity of pain are measured before and after the last session again.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Zeinab Mahmoudi
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
z.mahmoudi.pt93@gmail
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after being unidentified.
When the data will become available and for how long
The beginning of the access period is one month after the results are published.
To whom data/document is available
All those who need research results can receive the study documentation.
Under which criteria data/document could be used
All people who use the information are required to mention the source.
From where data/document is obtainable
To receive the information, they can contact the research author at the Faculty of Rehabilitation, Semnan University of Medical Sciences.
What processes are involved for a request to access data/document
After receiving the email from the applicant, the applicant will be sent a document within two weeks.