Comparison extraarticular dextrose with physiotherapy in chronic ankle tendinopathy
Design
Tow arm parallel group randomized trial
Settings and conduct
physiotherapy treatment study group that include 10 sessions of treatment with hotpack,ultrasound,TENS in the affected area is performed and in the other group 2 injections of extra articular prolotherapy with dextrose 12%and lidocaine2% 5 cc in the ankle in 501 hospital
Participants/Inclusion and exclusion criteria
20<age<50
MRI evidence of tendinopathy
conscious patient satisfaction
symptoms more than 6 month
rheumatological disease
diabetes
localized local infection
allergy to the drug to be injected
use of anticoagulants
INR disrupted
immunodeficiency
acute fracture
Intervention groups
20patient were in the dextrose injection and 20 were in physiotherapy group. physiotherapy treatment study group that include 10 sessions of treatment with hotpack,ultrasound,TENS in the affected area is performed and in the other group 2 injections of extra articular prolotherapy with dextrose 12%and lidocaine2% 5 cc in the ankle 1 month apart it is performed and the patients studied by two TSK questionnaires and cumberlands . they are followed at intervals of zero, 1 nd 3 months after the start of treatment .
Main outcome variables
pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039323N2
Registration date:2020-10-11, 1399/07/20
Registration timing:registered_while_recruiting
Last update:2020-10-11, 1399/07/20
Update count:0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
Zahra Rezasoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
z.rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of extra articular dextrose prolotherapy with Routine physiotherapy in chronic ankle tendinopathy
Public title
extra articular dextrose prolotherapy and physiotherapy in ankle tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20<age<50
MRI evidence of tendinopathy
conscious patient satisfaction
symptoms more than 6 month
Exclusion criteria:
rheumatological disease
diabetes
localized local infection
allergy to the drug to be injected
use of anticoagulants
INR disrupted
immunodeficiency
acute fracture
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocating of two groups with the same size of 20 participants (40 patients in total) we used block randomization with different block sizes. The sizes of blocks would be a multiple of 2 and a divisor of 40 (2,4,8). At first, the block sizes were selected randomly. Then, for each block, different permutations for equal group size were determined. Finally, one of the permutations was selected randomly. Random numbers were generated in an independent statistical office using Random allocation software.
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 Aja university of medical science
Street address
Etemadzade Ave.fatemi Ave, 501 hospital
City
Tehran
Province
Tehran
Postal code
1463773644
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.AJAUMS.REC.1399.119
Health conditions studied
1
Description of health condition studied
Ankle Tendinopathy
ICD-10 code
S90.91
ICD-10 code description
Unspecified superficial injury of ankle
Primary outcomes
1
Description
Evaluation of pain intensity
Timepoint
Eٍٍvaluation of pain intensity befor ,1 and 3 month after injection or physiotherapy
Method of measurement
Cumperland outcome score questionnaire
2
Description
Functional improvement
Timepoint
Evaluation of functional improvment befor ,1 and 3 month after injection or physiotherapy
Method of measurement
Cumperland outcome score questionnaire
3
Description
Kinesiophobia
Timepoint
Befor ,1 and 3 month after injection or physiotherapy
Method of measurement
Tampa Scale for Kinesiophobia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Physiotherapy treatment study group that include 10 sessions of treatment with Hotpack,Ultrasound,TENS in the affected area is performed
Category
Treatment - Devices
2
Description
Intervention group: 2 injections of extra articular prolotherapy with dextrose 12%and lidocaine2% 5 cc in the ankle 1 month apart it is performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501Hospital
Full name of responsible person
Sanaz Hamidipanah
Street address
501 Hospital,Etemadzade Ave, Fatemi Blv,Tehran Town
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 4421 6034
Email
Y.hamidihamidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaei
Street address
501 Hospital,Etemadzade Ave,Fatemi street,Tehran town
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 4421 6034
Email
y.hamidihamidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Army 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
Artesh University of Medical Sciences
Full name of responsible person
Sanaz Hamidipanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
501 Hospital Etemadzade Ave,Fatemi blv,Tehran town
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 4421 6034
Email
y.hamidihamidi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sanaz hamidipanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
501Hospital , Etemadzade Ave,Fatemi Blvd.Tehran
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 4421 6034
Email
y.hamidihamidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sanaz Hamidipanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
501Hospital, Etemadzade street Ave,Fatemi Ave,Tehran
City
Tehran
Province
Tehran
Postal code
141171854
Phone
+98 21 4421 6034
Email
y.hamidihamidi@yahoo.com
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