Determining the effect of balloon therapy on chronic knee pain and daily life activities of elderly women referred to day care centers in Qazvin.
Design
The clinical trial has a test and control group with random distribution by random number table method, phase 2 on 50 elderly women.
Settings and conduct
The research environment is Qazvin day care centers for the elderly. Available sampling will be done based on entry and exit criteria. Samples have chronic knee pain for at least the past three months. The cognitive ability of the samples will be determined based on the abbreviated cognitive test tool. Individuals will be divided into intervention and control groups by random allocation using the random number table method. Using the visual scale of pain and daily life activity questionnaire, the severity of pain and daily life activity in both groups will be measured. Twice a week for four weeks and during eight sessions of the desired intervention using 3 balloons, for 5-10 minutes will be performed on points SP10, SP9, ST36. One week after the last intervention, the intensity of pain and daily life activity in both groups will be measured and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having chronic knee pain during the last trimester. The condition for not entering the study is less than 60 years old.
Intervention groups
In the intervention group, twice a week for four weeks and during eight sessions, the desired intervention will be performed using 3 balloons for 5-10 minutes on three points in the knee. No intervention is performed for the control group during the study.
Main outcome variables
The main consequences include chronic pain and daily life activities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053996N1
Registration date:2022-03-10, 1400/12/19
Registration timing:prospective
Last update:2022-03-10, 1400/12/19
Update count:0
Registration date
2022-03-10, 1400/12/19
Registrant information
Name
neda najafy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 2940
Email address
nedanajafy1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-30, 1401/01/10
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dry Cupping therapy on chronic knee pain and Activity of daily living (ADL) among female older adults.
Public title
Effect of dry Cupping therapy on chronic knee pain and Activity of daily living (ADL) among female older adults.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic knee pain for the past three months.
Exclusion criteria:
Age less than 60 years
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by random number table method to be placed in two groups of control and intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Rehabilitation Sciences and Social Health
Street address
Unit 242 , East Sky Tower, Palestine Street
City
Qazvin
Province
Qazvin
Postal code
3415745187
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.USWR.REC.1400.306
Health conditions studied
1
Description of health condition studied
Chronic knee pain in the elderly
ICD-10 code
M25.56
ICD-10 code description
Pain in knee
Primary outcomes
1
Description
Score of daily life activity in Bartel questionnaire
Timepoint
Before the intervention and one week after the last intervention
Method of measurement
Bartel Activity of Daily Living
2
Description
Chronic pain
Timepoint
Before the intervention and one week after the last intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this intervention, after passing a training course under the supervision of an acupuncturist, we hold a ball of 95% alcohol-soaked cotton with a pair of pliers and set it on fire. Any excess alcohol must be removed from the cotton before turning on. The balloon stays in the designated points (SP10, SP9, ST36) for about five minutes. To separate the cups, gently press the edge of the cup with your index finger and allow some air to enter. In general, for each affected knee (both elderly knees may be affected), the treatment period is twice a week for four weeks.
Category
Treatment - Other
2
Description
Control group: This group does not receive any intervention during the study. At the end of the study, two sessions of balloon therapy will be performed for the control group and the use of this method to possibly improve the daily activities of the elderly will be explained.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin day care centers
Full name of responsible person
Hesamedin alame
Street address
Elderly day care centers
City
Qazvin
Province
Qazvin
Postal code
۱۱۳۶۵/۴۱۸۷
Phone
+98 28 3356 1060
Email
h.alame@behzisti.gov.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Massoud Fallahi
Street address
Koodkiar St , Velenjak St , University of Rehabilitation Sciences and Social Health
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences