Comparison the effect of ultrasound guided prolotherapy and ultrasound guided corticosteroid injection on pain score and foot function in patients with plantar fasciitis.
Comparison of the effectiveness of the two methods of ultrasound guided injection of corticosteroid or prolotherapy on the pain score and foot function in patients with plantar fasciitis to detect the more effective method.
Design
Parallel group randomized clinical trial with blinded participant and operator on 44 patients. Block randomization is implicated.
Settings and conduct
The clinical trial will be done on patients with plantar fasciitis who present to the Imam Reza clinic, Shiraz University of Medical Sciences, during March 2021 to June 2021. Patients will allocate to the each groups of corticosteroid or prolotherapy groups with block randomization. The operator physician and participants will be blinded to the group allocation.
Participants/Inclusion and exclusion criteria
The inclusion criteria for participants are diagnosis of plantar fasciitis, age older than 18 and not using of analgesics during the study. The exclusion criteria are diagnosis other disease which involves foot joints; including ankylosing spondylitis, Reiter's syndrome, rheumatoid arthritis and gout; a history of drug sensitivity to the drug compounds using in the study, a history of local injection for foot pain within the past 6 months, pregnancy and lactation.
Intervention groups
In corticosteroid group, 40 milligrams of methyl acetate an 1 cc of lidocaine 2% solution will inject with the plantar approach under ultrasound guide. In prolotherapy group, 1 cc of dextrose 50% solution and 1 cc lidocaine 2% solution will inject as above.
Main outcome variables
Patients' pain score in 1month and 3 month follow up; patients' foot function index in 1 month and 3 month follow up.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210305050582N1
Registration date:2021-03-19, 1399/12/29
Registration timing:registered_while_recruiting
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Fateme Alaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 4132
Email address
ftm.alaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of ultrasound guided prolotherapy and ultrasound guided corticosteroid injection on pain score and foot function in patients with plantar fasciitis.
Public title
Prolotherapy and corticosteroid injection in plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with plantar fasciitis.
No analgesic using during the study.
Over 18 years of age.
Exclusion criteria:
Patients with ankylosing spondylitis.
Patients with Reiter's syndrome.
Patients with rheumatoid arthritis.
Patients with gout disease.
Anatomical disturbance in the site of the lesion.
Drug sensitivity to corticosteroids or lidocaine.
Any local injection for plantar fasciitis within the past 6 months (including corticosteroid, platelet rich plasma, prolotherapy and lidocaine).
Known coagulopathy.
Pregnancy or lactation.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will allocate to the either corticosteroid or prolotherapy groups by block randomization. Block randomization will be done by random blocks of four with letters A and B, without replacement. For example, for AABB block, the first two patients will include group A and the latter two patients will include group B. Allocation of treatment to the groups A and B will be done by simple randomization, using a coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the participant, the physician; who who performs the procedure; and the study assistant; who is the responsible of patients' follow up; will be blinded to the groups allocation.
Placebo
Not used
Assignment
Parallel
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
Faculty of research, Floor 7th, Central Building of Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-09-16, 1398/06/25
Ethics committee reference number
IR.SUMS.MED.REC.1398.397
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M70-M79
ICD-10 code description
Other soft tissue disorders
Primary outcomes
1
Description
The patients' reported pain score based on visual analog scale (VAS).
Timepoint
Before the intervention, first month and third month.
Method of measurement
Patients will quantify their pain by VAS using the numbers 1; for the least severity; to 10; for the most severity; of he pain.
2
Description
The foot function index (FFI)
Timepoint
Before the intervention, first month and third month.
Method of measurement
Standard FFI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment with local injection of 40 mg methyl prednisolone acetate and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection.
Category
Treatment - Drugs
2
Description
Intervention group 2: Treatment with injection of 1 milliliter of 50% dextrose solution and 1 milliliter of 2% lidocaine solution under ultrasound guide with plantar approach. A 23 gauge needle will be used for injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic, Shiraz University of Medical Sciences.
Full name of responsible person
Fateme Alaei
Street address
Imam Reza clinic, Namazi Sq. Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeyanzade
Street address
Floor 7th, Central building of Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?