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Evaluation of the efficacy of behavioral remodeling for treatment of resistant pes anserine tendino-bursitis

Protocol summary

Summary
Evaluation of the efficacy of behavioral remodeling for treatment of resistant pes anserine tendino-bursitis This study is a monocentric, randomized (Packed envelope method), controlled clinical trial. Target sample size: 60 patients with PATB who consult to rheumatologist Inclusion criteria: 50 to 60 years old females with resistant PATB, BMI=25-30 kg/m2 exclusion criteria : patients with heart diseases, DM, HTN, peptic or duodenal ulcer, cancer, hepatic or renal disorders, analgesic drugs intolerance, history of knee surgery or RA or trauma , previous treatment of PATB during last year In intervention and control group, in addition to receive naproxen (500 mg q 12 hrs) or diclofenac (75 mg per day) and pantoprazole (40 mg per day) for 2 weeks, weight loss, avoid to kneeling down and sitting crossed leg, quadriceps muscle strengthening which is same as control group, training about manner of getting up will done, so when patient gets up tibia bone is in neutral position and is not in external rotation position. The control group is not taught how to get up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031112823N4
Registration date: 2017-08-22, 1396/05/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
Jamileh Moghimi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1332 8017
Email address
moghimi_jam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of behavioral remodeling for treatment of resistant pes anserine tendino-bursitis
Public title
Evaluation of the efficacy of behavioral remodeling for treatment of resistant pes anserine tendino-bursitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 50 to 60 years old female with BMI=25 - 30 kg/m2 Exclusion criteria : Patient with cardiac disease, Diabetes, HTN , Peptic ulcer and duodenal ulcer, Cancer , Hepatic and Renal disorder , analgesic drugs intolerance , previous knee surgery or trauma or RA and previous treatment of PATB during last year
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-03-02, 1395/12/12
Ethics committee reference number
IR.SEMUMS.REC.1395.220

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
Severity of pain
Timepoint
Befor intervantion , 2 months after intervention
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Body mass index
Timepoint
Befor intervantion , 2 months after intervention
Method of measurement
weight/(height)2

Intervention groups

1

Description
In intervention group, in addition to receive naproxen (500 mg q 12 hrs) or diclofenac (75 mg per day) and pantoprazole (40 mg per day) for 2 weeks, weight loss, avoid to kneeling down and sitting crossed leg, quadriceps muscle strengthening which is same as control group, training about manner of getting up will done, so when patient gets up tibia bone is in neutral position and is not in external rotation position. Patient will be asked to do this training for 8 weeks and also companion of patient will be asked to observe the patient. The researcher will follow the patients by call them every other day.
Category
Behavior

2

Description
In control group, patients receive naproxen (500 mg q 12 hrs) or diclofenac (75 mg per day) and pantoprazole (40 mg per day) for 2 weeks, weight loss, avoid to kneeling down and sitting crossed leg, quadriceps muscle strengthening. There is no behavioral training in this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Jamileh Moghimi
Street address
2nd floor, Sadaf complexes, Saadi Square, Semnan.
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Ali Rashidy-Pour
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Jamileh Moghimi
Position
Rheumatologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Jamileh Moghimi
Position
Rheumatologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rheumatologist
Position
Rheumatologist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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