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Comparing the efficacy of local corticosteroid injection and Extracorporeal shockwave therapy in patients diagnosed with pes anserine bursitis

Protocol summary

Study aim
The aim of this study will be compare the effectiveness of topical corticosteroid injection and extracorporeal shockwave therapy on pes anserine thickness, pain intensity and quality of life in patients with pes anserine bursitis.
Design
This study is a phase 3 clinical trial that will be performed on 60 patients with pes anserine bursitis.. Allocation of patients will be done randomly with computer software in two treatment group : topical corticosteroid injection and ESWT.
Settings and conduct
In this study, which will be performed at Besat Hospital in Hamadan, the effect of two treatments of local injection of corticosteroids and ESWT in patients with pes anserine bursitis.will be evaluated and compared. The outcome evaluator will not be aware of the type of intervention (single blinded)
Participants/Inclusion and exclusion criteria
Participants will be patients 18 to 65 years old with pes anserine bursitis . At least three months of history of disease, and minimum pain intensity above 3 based on visual analog scale are inclusion criteria and comorbidity of other knee, neurological and motor diseases, systemic diseases, history of surgery or recent trauma of Knee, vascular disease, and corticosteroid therapy history in pas 4 months are not been included in the study
Intervention groups
The intervention groups consisted of two groups of 30 people receiving local corticosteroid injections and ESWT, which will be randomly selected. The ESWT group will undergo an ESWT once a session per week for three weeks and the second group will receive a local corticosteroid injection containing 40 mg of methylprednisolone and 1 ml of 1% lidocaine under ultrasound guidance.
Main outcome variables
Outcomes of the intervention include changes in pes anserine thickness, pain, and quality of life that will be assessed before and after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N16
Registration date: 2021-07-17, 1400/04/26
Registration timing: prospective

Last update: 2021-07-17, 1400/04/26
Update count: 0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of local corticosteroid injection and Extracorporeal shockwave therapy in patients diagnosed with pes anserine bursitis
Public title
Comparison of the effect of corticosteroids and extracorporeal shockwave therapy in the treatment of pes anserine bursitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PAB according to clinical and paraclinical criteria by a specialist physician Diagnosis period at least 3 months Age 65-18 years Pain severity greater than 3 according to VAS scale
Exclusion criteria:
Comorbidity of other knee diseases such as advanced osteoarthritis, infection and ... History of recent knee surgery or trauma Vascular disease History of corticosteroid therapy during the last 4 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 eligible patients will be selected by convenience sampling. The samples will be randomly coded in two groups E and C with computer software and the relevant codes will be entered in the raw checklists. Upon patient referral, one of the checklists will be randomly assigned to each patient. If the selected code is E, the patient will be Will be allocated to ESWT treatment group and if C will be Will be allocated to topical corticosteroid injection group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blinded study, the evaluator of intervention outcomes will blinded about the patients' group therapy.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.UMSHA.REC.1400.069

Health conditions studied

1

Description of health condition studied
Pes anserine bursitis
ICD-10 code
M70.5
ICD-10 code description
Other bursitis of knee

Primary outcomes

1

Description
Pes Anserin thickness changes
Timepoint
Before, 1 and 3 month after treatment
Method of measurement
Sonography

2

Description
Pain severity
Timepoint
Before, 1 and 3 month after treatment
Method of measurement
Visual Analogues Scale

Secondary outcomes

1

Description
Patients quality of life
Timepoint
Before, 1 and 3 months after treatment
Method of measurement
Sf-12 questionnaire

2

Description
Treatment complications
Timepoint
1 and 3 months after treatment
Method of measurement
Examination and interview

Intervention groups

1

Description
Intervention group: Patients in this group will receive extra corporeal shock wave therapy (ESWT). ESWT will be done in one session per week for 3 consecutive weeks. ESWT will be performed while the patient is lying on a quiet bed at the point where the greatest intensity of tenderness is found. Device settings: frequency 4 Hz, pulse 1500, energy 20.15 mj / mm
Category
Treatment - Other

2

Description
Intervention group: Patients in this group will receive a local injection of corticosteroids. For this purpose, first knee ultrasound is performed and the appropriate point for injection will be identified and marked; Then, under ultrasound guidance, 40 mg of methylprednisolone and 1 ml of 1% lidocaine will be injected at the marked site.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Lobat Majidi
Street address
Shahid Beheshti Blv
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0020
Email
besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Loabat Majidi
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Besat Hospital, Shahid Beheshti Blv, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
lobat.majidi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
00988138380572
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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