Comparative study of the effect of home(rehabilitation at home) and clinical interventions(rehabilitation treatment) on reducing pain and inflammation of plantar fascia
A comparative study of the effect of home and clinical interventions on reducing pain and inflammation of the plantar fascia
Design
Clinical trial with control group, cross-group, one-way blind, simple randomization
Settings and conduct
Clinical intervention will be performed in the rehabilitation center of Shahid Chamran Hospital by a therapist. Home intervention will be performed at home by the patient.Each intervention lasts for two weeks. Interventions include warming, massage, Passive ROM, Mobilization and stretching.The time of intervention sessions is 45 minutes per day.
The study is one-way blind and the evaluator does not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with a diagnosis of plantar fasciitis by a specialist.
Exclusion criteria: diseases that can cause pain in the heel area.
Intervention groups
Group A includes patients with plantar fasciitis who first receive clinical intervention for two weeks, then receive home intervention for two weeks.
Group B includes patients with plantar fasciitis who first receive home intervention for two weeks, then receive clinical intervention for two weeks.
Main outcome variables
pain; hypersensivity; satisfaction; range of motion;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210207050275N1
Registration date:2021-12-26, 1400/10/05
Registration timing:prospective
Last update:2021-12-26, 1400/10/05
Update count:0
Registration date
2021-12-26, 1400/10/05
Registrant information
Name
narges ghamari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 4504
Email address
nargesghamari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of home(rehabilitation at home) and clinical interventions(rehabilitation treatment) on reducing pain and inflammation of plantar fascia
Public title
Comparative of home and clinical interventions on plantar fasciitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inflammation of the plantar fascia
No surgery or fracture in the last month
Exclusion criteria:
Reluctance to participate in the study
People who have diseases that cause pain and inflammation in the foot
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation Software and permutation block method and creating 10 blocks with a size of 6, a randomization table of sequence samples (from 1 to 60) will be made and the patients will be divided into A and B intervention groups. Allocation concealment will be conducted by using sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessors are unaware of which group the participants belong to
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.SUMS.REC.1400.544
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
Pre intervention, 3,6,9,12,15,18,21 days after intervention
Method of measurement
pain analog scale
2
Description
hypersensivity
Timepoint
Pre intervention, 3,6,9,12,15,18,21 days after intervention
Method of measurement
Numeric Analog Scale, Mcgill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Home interventions include placing the foot up to the knee in warm water for 10 minutes, then using a home massager made by Abarteb for 5 minutes, then 15 minutes of passive movements and 15 minutes of stretching Which is adjusted according to the facilities of the house and the patient's ability.
Category
Rehabilitation
2
Description
Intervention group: Clinical treatment includes 10 minutes of hot pack on the muscles, 5 minutes of foot massage, 15 minutes of mobilization and 15 minutes of stretching .Interventions are performed using the equipment available in the clinic(Hot pack, Electric massager, Traband, Frame) or manually by the therapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
narges ghamari
Street address
Bone and Joint Diseases Research Center,Shahid Chamran Hospital, Chamran Bolv.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3623 4504
Fax
+98 71 3623 4504
Email
nargesghamari@yahoo.com
Web page address
http://orthoresearch.sums.ac.ir/fa/index.html
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mahtab Memarpor
Street address
Shahid Chamran Hospital,Chamran Bolv, Shiraz
City
shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3623 4504
Fax
+98 71 3623 4504
Email
nargesghamari@yahoo.com
Web page address
http://orthoresearch.sums.ac.ir/fa/index.html
Grant name
No
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
narges ghamari
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Chamran Hospital, Chamran Bolv, Shiraz
City
shiraz
Province
Fars
Postal code
7194815644
Phone
0098716234504
Email
nargesghamari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
narges ghamari
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Chamran Hospital, Chamran Bolv, Shiraz
City
shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3623 4504
Fax
+98 71 3623 4504
Email
nargesghamari@yahoo.com
Web page address
http://orthoresearch.sums.ac.ir/fa/index.html
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
narges ghamari
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Chamran Hospital, Chamran Bolv, Shiraz
City
shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3623 4504
Email
nargesghamari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
it is to be shared the primary outcome measure
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
these data is available for people working in academic institutions or people working in businesses and they can apply to receive it
Under which criteria data/document could be used
Individuals can receive information via email at the discretion of the authors
From where data/document is obtainable
nargesghamari@yahoo.com
What processes are involved for a request to access data/document
At the discretion of the authors, the documents will be available to the applicant within a week