Study effect of the soft medical insole with lateral wedge on reducing pain, improving performance and quality of life of the elderly with knee osteoarthritis
Study effect of the soft medical insole with lateral wedge on reducing pain, improving performance and quality of life of the elderly with knee osteoarthritis.
Design
Clinical trial with control group and one-way blind on 30 patients. Lottery is used for randomization.
Settings and conduct
The research site is located in the orthopedic clinic of Isfahan University of Medical Sciences.
Patients will complete 2 questionnaires before and one month after the start of the study and the quality of life and knee function pain will be assessed.
Participants/Inclusion and exclusion criteria
Young elderly
060 to 69 who have a history of pain and tenderness in the medial compartment.
Intervention groups
The intervention group receives a soft medical insole with 7 degrees of lateral wedge .This intervention reduces the weight pressure and ground reaction force in the internal compartment of the knee.
The control group does not receive any payment and they only complete the questionnaires included in the appendix of the thesis
Main outcome variables
Knee joint pain, quality of life and knee function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220428054688N1
Registration date:2022-09-16, 1401/06/25
Registration timing:prospective
Last update:2022-09-16, 1401/06/25
Update count:0
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
zahra Abdolhosseinpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 4945
Email address
za.abdolhosseinpoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effect of the soft medical insole with lateral wedge on reducing pain, improving performance and quality of life of the elderly with knee osteoarthritis
Public title
Study effect of the soft medical insole with lateral wedge of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Young elderly aged 60 to 69 years and both sexes
History of pain and tenderness in the internal compartment of the knee in the last six months
Average knee pain of at least 3 on the (Visual Analogue Scale) VAS scale
Tibiofemoral internal involvement and reduction of joint space
Grade 1 to 3 in the inner part of the tibofemoral in kellgren Lawrence (k/L)
Tendency to wear insoles for shoes for at least 4 hours a day.
Exclusion criteria:
Intra-articular injection in the last six months
History of any knee surgery or lower limb injury
Inability to walk without assistance, cane or walker
Involvement and osteophytes in the outer part of the tibiofemoral more than the inner
Rheumatoid arthritis or other inflammatory arthritis, diabetic neuropathy
Current use of knee braces or analgesics
Body mass index (BMI) more than 30 kg per square meter
Elderly people with cognitive and mental problems or low alertness and use of confusing and sleep-inducing drugs
Age
From 60 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on lottery
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants are kept blind to the study.
From numbers 1 to 30, each patient chooses a number by lottery. Every patient who took an even number out of the container is the intervention group and the odd number is the control group. The researcher who is responsible for evaluating the outcome and analyzing the data is aware of the details.
Placebo
Not used
Assignment
Parallel
Other design features
Evaluation of the effect of soft medical insole with lateral wedge on knee osteoarthritis only in young elderly
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Nursing, Management and Rehabilitation of Isfahan University of M
Street address
Hezar jerib street' Isfahan' Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.068
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score
Timepoint
30 days
Method of measurement
From 2 questionnaires :Visual Analogue Scale (VAS)، Knee Injury and Osteoarthritis Outcome Score (KOOS)
2
Description
Quality of Life
Timepoint
30 days
Method of measurement
Quality of Life Scale developed through the World Health Organization (bref )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: soft medical insoles of polyurethane type with hardness between 10 and 25 and will be commercially available. The sole will have a 7-degree outer edge and a length equal to the length of the foot. The insole cover is synthetic leather and has an internal arch. People participating in the study must use insoles for 4 weeks and at least 4 hours a day, but they can wear them as long as they want. Insoles in shoes or in a chair that the person It will be commonly used in the past months. So that the shoes or sandals themselves do not have a positive or negative effect on the research variables.
Category
Rehabilitation
2
Description
Control group: does not receive any intervention. The control group with all the same conditions at the beginning of the project and after one month will complete the questionnaires attached to the proposal.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra University Hospital
Full name of responsible person
zahra abdolhosseinpour
Street address
Al-Zahra Medical Education Center, Sofa Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3131
Fax
Email
international@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?