The aim of this study is to investigate the effect of patellar taping on the pain and functional status of patients with medial meniscal injury
Design
In this study, patients are randomly divided into two groups. There are 15 patients in each group. The Kinesio tape group receives tape and the exercise program and the control group receive only the exercise program. Both groups are treated for 4 weeks. Patients are evaluated before and after treatment
Settings and conduct
This study is conducted to investigate the effect of interventions on the pain and function of patients with medial meniscal injury clinic of Shiraz Rehabilitation Sciences Faculty. In this study, patients are divided into two groups, main intervention and control groups, and treated for 4 weeks. Before starting the study, all subjects are evaluated for the outcomes and also they evaluated after the end of the treatment period again. In this study, all evaluations will be done by a therapist and all treatments will be done by another therapist.
Participants/Inclusion and exclusion criteria
Patients with internal damage to the knee with a diagnosis of internal degenerative damage, which has Kellgren-Lawrence Grade 0, 1 or 2
These people should not have a history of knee and lower extremity surgery or balance problems
Intervention groups
Kinesio tape group: The group is treated with tape and a specific sports program for four weeks, every other day.
Control group: This group receives a specific sports program that individuals should undertake under the supervision of a physiotherapist three times a week.
Main outcome variables
1- one leg hop
2- one leg rising
3- square hop
4- Knee Injury and Osteoarthritis Outcome
5- pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037576N4
Registration date:2019-08-08, 1398/05/17
Registration timing:prospective
Last update:2019-08-08, 1398/05/17
Update count:0
Registration date
2019-08-08, 1398/05/17
Registrant information
Name
Mohammad Hadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
hadadim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of patellar taping on pain intensity & functional status on patients with medial meniscal injury
Public title
effect of taping on medial meniscal injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
medial knee pain experienced during the last 1–3 months without a trauma
degenerative tear in the medial meniscus as diagnosed by the radiologist on magnetic resonance imaging
grade 0, 1, or 2 Kellgren and Lawrence (K–L) based on radiographic or MRI
Individuals do not need to undergo surgery based on classifications and physician opinion
Exclusion criteria:
Knee locking or traumatic injury that requires surgery
history of previous surgery around the knee joint
Tumors suspected of malignancy
Balance and neurological impairment
Lower limb pain except knee joint
Age
From 35 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
patients are randomly divided into two groups of Kinesio Tape and controls based on blocked randomization method. In this study, the block size of 4 was selected. The blocks were arranged randomly. The participants were assigned to groups with a ratio of 1: 1.
To blind the allocation of participants to the groups, sequentially numbered, sealed, opaque envelopes are used. It should be noted that the testers of this study will be unaware of the randomization stage, and this will be done by another person.
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 on Research in the Faculty of Rehabilitation Sciences
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Approval date
2019-08-16, 1398/05/25
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.009
Health conditions studied
1
Description of health condition studied
medial meniscal injury
ICD-10 code
S83.20
ICD-10 code description
Tear of unspecified meniscus, current injury
Primary outcomes
1
Description
one leg hop outcome
Timepoint
Before starting the study and 4 weeks after starting the study
Method of measurement
Measure the distance the patient can hop
2
Description
one leg rising outcome
Timepoint
Before starting the study and 4 weeks after starting the study
Method of measurement
one leg rising test score
3
Description
square-hop outcome
Timepoint
Before starting the study and 4 weeks after starting the study
Method of measurement
square-hop test score
4
Description
Knee injury and Osteoarthritis outcome
Timepoint
Before starting the study and 4 weeks after starting the study
Method of measurement
KOOS questionnaire score
5
Description
pain intensity outcome
Timepoint
Before starting the study and 4 weeks after starting the study
Method of measurement
Pain Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants in this group receive exercise with knee Kinesio taping for 4 weeks, every other day. the exercises include: Stretching of knee extensors and flexors, Knee extension in sitting position, Knee flexion in sitting position, Stationary bicycling, Half squats with \45 of flexion with weights, Squats with full flexion with weights
Category
Rehabilitation
2
Description
Control group: participants in this group receive an exercise for 4 weeks, every other day. the exercises include: Stretching of knee extensors and flexors, Knee extension in sitting position, Knee flexion in sitting position, Stationary bicycling, Half squats with \45 of flexion with weights, Squats with full flexion with weights
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Clinic of Shiraz Rehabilitation Sciences Faculty
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
hadadi.to7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
hadadi.to7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
hadadi.to7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hadadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
hadadi.to7@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
hadadi.to7@gmail.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