Determining the effect of local corticosteroid injection along with percutaneous fasciotomy compared to local ozone injection in patients with plantar fasciitis
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 2 on 40 patients, rand function of Excel software was used for randomization.
Settings and conduct
The aim of this study is to evaluate therapeutic response of ozone injection and local corticosteroid injection and fasciotomy in treatment of plantar fasciitis. to do so, 40 patients referring to Tabriz shahid madani hospital with diagnosis of plantar fasciitis will be included to the study.The patients of each group are unaware of the treatment of the other group, and the analyst will not be aware of the type of treatment in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with plantar fasciitis who have not responded to routine medical treatments for more than a month.
Exclusion criteria: history of RA; history of direct trauma; history of local injection or physical therapy in the last 3 months' pain behind the heel related to Achilles bursitis and...; active S1 radiculopathy; the presence of trigger points in the calf muscles.
Intervention groups
The group that receives corticosteroid injection. The group that is subjected to ozone injection
Main outcome variables
Pain relief; improvement of function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220614055168N1
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Sina Nasirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3177 1041
Email address
nasirzadeh89a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-15, 1401/10/25
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of local corticosteroid injection with percutaneous fasciotomy and ozone in the treatment of plantar fasciitis
Public title
Corticosteroid in plantar fasciitis "Effect of ozone in the treatment of plantar fasciitis"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with plantar fasciitis with local pain and sensitivity of the soles of the feet or heels, especially in the morning, who have not responded to routine medical treatments for more than a month, are included in the study with informed consent.
Exclusion criteria:
History of systemic inflammatory disease such as RA
History of direct trauma with and without fractures of the plantar bones
History of local injection or physical therapy in the last 3 months
pain in posterior heel associated with Achilles bursitis
The presence of S1 active radiculopathy, which mainly explains the cause of plantar fascia pain
The presence of trigger points in the calf muscles
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients of each group are unaware of the treatment of the other group, and the analyst will not be aware of the type of treatment in the groups. The randomization of the patient is such that the patient randomly chooses one of the ozone or corticosteroid drugs for injection. This is implemented in such a way that two packages containing the names of each of the treatment methods are provided to the patient and the patient chooses one of them without knowing the contents of the package, yet the type of treatment is given to the patient. will be announced.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Ave., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-07-12, 1401/04/21
Ethics committee reference number
IR.TBZMED.REC.1401.315
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
Plantar pain score (VAS)
Timepoint
At the time of treatment, 4 weeks and 8 weeks after treatment
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical corticostroid as 40 mg methylprednisolone which is going to be injected once at the site of plantar fascia. percutaneous fasciotomy is going to be done in the session of corticosteroid injection therapy.
Category
Treatment - Drugs
2
Description
Intervention group: topical Ozone, 3cc, injected once at the site of plantar fascia