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Comparison of the effectiveness of topical corticosteroid injection and high-level laser therapy in patients with acute post-Anserin bursitis(PAB)

Protocol summary

Study aim
Comparison of the effect of topical cortico-steroid and high-level laser therapy on pes anserine bursitis thickness, pain intensity of knee and quality of life in patients with acute PAB
Design
A clinical trial with a control group, with parallel groups, single blind, randomized phase 3 will be performed on 60 patients. The envelope method will be used for randomization.
Settings and conduct
This study will be performed to compare two rehabilitation methods in patients with acute pes anserine bursitis in the physical medicine clinic of Besat Hospital in Hamadan. The evaluator will be blinded to the patients' group therapy. Group A will use a gallium arsenide diode laser (model 4 cube-laser-K) with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 4 joules per square centimeter. Group B will receive a topical injection of corticosteroids under a sono guide of 1 ml of triamcinolone and 1 ml of 2% lidocaine as a single dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of PAB according to clinical criteria and imaging finding, and age 18-65 years, Non-entry criteria: Comorbidity with rheumatoid arthritis, and treated with corticosteroids at study time or during the last 4 months
Intervention groups
Group A will be use of gallium aluminum arsenide diode laser (model 4 cube-laser-K) with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 4 joules per square centimeter. The total duration of treatment in each session will be 5-7 minutes for 3 consecutive weeks (5 sessions). Group B will receive topical corticosteroid injections under sono guide 1 ml triamcinolone with 1 ml lidocaine 2% single dose.
Main outcome variables
Pes Anserin changes including thickness, tendonitis and bursitis, severity of knee pain, quality of life associated with knee pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N19
Registration date: 2021-12-28, 1400/10/07
Registration timing: prospective

Last update: 2021-12-28, 1400/10/07
Update count: 0
Registration date
2021-12-28, 1400/10/07
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
2022-01-21, 1400/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of topical corticosteroid injection and high-level laser therapy in patients with acute post-Anserin bursitis(PAB)
Public title
Treatment of acute post-Anserin bursitis with topical injection of corticosteroids and high-level laser therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PAB according to clinical criteria and imaging by a specialist physician At least 3 months after diagnosis Age 18-65 years Minimum pain intensity according to VAS> 3
Exclusion criteria:
Comorbidity with other diseases such as: advanced osteoarthritis, infection, neurological and motor diseases (stroke, Parkinson's, myopathies, neuropathies, ....), other systemic diseases such as rheumatoid arthritis and heart disease History of recent knee surgery or trauma Treatment with corticosteroid now or 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
We made 60 cards and write letter I on 30 for Intervention and on the other 30 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and will be opened, based on selected letter I or C patients will be assigned to intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who asses outcome will be blinded to the patients' group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
shahid fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.UMSHA.REC.1400.224

Health conditions studied

1

Description of health condition studied
pes anserine bursitis knee
ICD-10 code
M06.26
ICD-10 code description
Rheumatoid bursitis, knee

Primary outcomes

1

Description
Pes anserine bursitis thickness changes
Timepoint
Before treatment, one month later, and three months after treatment
Method of measurement
sonography

2

Description
pain severity of knee
Timepoint
Before treatment, one month later, and three months after treatment
Method of measurement
By Visual Analogue Scale

Secondary outcomes

1

Description
Patients Quality of life
Timepoint
Before treatment, one month and three months after starting treatment
Method of measurement
With SF-12 Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: One group will undergo high-level laser therapy. For this purpose, gallium aluminum arsenide diode laser (model 4 cube-laser-K) with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 4 joules per square centimeter will be used . The total duration of treatment in each session will be 5-7 minutes for 3 consecutive weeks (5 sessions).
Category
Rehabilitation

2

Description
Intervention group: The other group will receive a topical injection of corticosteroids. The corticosteroid contains 1 ml of triamcinolone and 1 ml of 2% lidocaine, which will be injected topically into the knee area under the sono guide single dose.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Behnaz Alaei
Street address
Shahid Beheshti
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 918 818 6269
Email
aalaie_behnaz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Shokohi
Street address
Shahid Fahmide
City
Hamedan
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
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

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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