Protocol summary

Study aim
Comparison of the effect of knee and quadriceps kinesio tape with sham kinesio tape on knee proprioception , pain, balance and quality of life in persons over 45 years old with knee osteoarthrosis
Design
Randomized clinical trial with control group, with parallel groups,double blind, randomized, An intervention group and a control group (sham), Randomization through sealed envelopes, The sample size would have been n=22 in each groups with a 10% attrition rate.
Settings and conduct
Place the plot : Arman Shayan Rehabilitation Center This is a double-blinded randomized clinical trial. The interventions will perform by the physical therapist and the assessments and data collection will conduct by another therapist. The interventionist will aware of the groups allocation, while the patients and the outcome assessor will blind to the allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with knee osteoarthrosis; Knee pain history for 6 months or more; Pain score between 4 to 7 on a visual analog scale; Radiological signs in affected knee; Age ˃45 years; Exclusion criteria : Knee joint injections within the previous 6 months; History of lower limbs fracture within the previous 6 months; Articular inflammatory diseases; Alternating swelling of the knee; History of skin allergy; History of knee soft tissue injuries or knee surrounding structures injuries; Balance disorder due to vestibular system disorders; History of knee or hip replacement; Rheumatoid arthritis; Deformity or contracture in the ankle, knee, or hip joints;
Intervention groups
1) The treatment group received 3 physiotherapy exercises and kinesio tape therapy 2) control group received the same 3 physiotherapy exercises and sham kinesio tape
Main outcome variables
knee Joint position sense (proprioception) error, Rest pain and task pain, Balance, Quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180916041051N1
Registration date: 2018-12-22, 1397/10/01
Registration timing: retrospective

Last update: 2018-12-22, 1397/10/01
Update count: 0
Registration date
2018-12-22, 1397/10/01
Registrant information
Name
Shabnam Shahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8769
Email address
shahali.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-08-01, 1397/05/10
Actual recruitment end date
2018-09-15, 1397/06/24
Trial completion date
2018-09-15, 1397/06/24
Scientific title
The effect of kinesio tape on knee proprioception, pain, balance and quality of life in patients with knee osteoarthritis- a double blind randomized controlled trial
Public title
The effect of kinesio tape on knee proprioception, pain , balance and quality of life in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 2, 3 OA knee (tibiofemoral) according to kellgren-and-lawrence-system Diagnosed and referred by a specialist Pain score between 4 to 7 on a visual analog scale Radiological signs in affected knee Age ˃45 years Knee range of motion: 0 to 100 degree Body mass index between 20 and 30 knee pain history for 6 months or more.
Exclusion criteria:
Using knee Kinesiotape within the previous 6 months Knee joint injections within the previous 6 months Using electrical stimulation within the previous 3 months Previous knee surgery History of lower limbs fracture within the previous 6 months Articular inflammatory diseases Alternating swelling of the knee History of skin allergy Patients with diabetic neuropathy Referral pain to the knee History of knee soft tissue structures injuries or knee surrounding structures injuries Balance disorder due to vestibular system disorders Patellofemoral pain syndrome of the affected side History of knee or hip replacement Rheumatoid arthritis Neurological diseases Deformity or contracture in the ankle, knee, or hip joints Ankle or hip joints osteoarthritis
Age
From 45 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Actual sample size reached: 47
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization procedures (computerized random numbers) will be conduct, and sequentially numbered index cards with the random assignment will prepare by an investigator with no clinical involvement in the study. The index cards will fold and place in sealed, opaque envelopes. Then, the blind investigator will open each envelope and allocate the participants to the Kinesio taping or placebo taping group according to the selected index card.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded randomized clinical trial. Participants and assessor will be blind to the study groups. The interventions will perform by the physical therapist at a university research clinic, and the assessments and data collection will conduct by another therapist. The interventionist will aware of the groups allocation, while the patients and the outcome assessor will blind to the allocation
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.IUMS.REC.1397.059

Health conditions studied

1

Description of health condition studied
knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]

Primary outcomes

1

Description
knee joint position sense error (proprioception)
Timepoint
Before the intervention, 30 minutes after the first intervention session, after the fifth session, one week after the last evaluation for follow up
Method of measurement
inclinometer

2

Description
pain
Timepoint
Before the intervention, 30 minutes after the first intervention session, after the fifth session, one week after the last evaluation for follow up
Method of measurement
Visual analog scale

3

Description
Balance
Timepoint
Before the intervention, 30 minutes after the first intervention session, after the fifth session, one week after the last evaluation for follow up
Method of measurement
Berg balance test

4

Description
Quality of life
Timepoint
Before the intervention, after intervention sessions
Method of measurement
Persian version of the WOMAC questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: this group received 3 daily therapeutic exercises (three times a day with 10 repetition) plus 5 sessions kinesiotape therapy. The exercises were including: straight leg raising in supine position, knee flexion and extension in sitting position on a chair and isometric contraction of knee muscles in sitting position. Patients were trained to do the exercises at home. The kinesiotape is an adhesive linen. It has roughly the same thickness as the epidermis and its use has become increasingly popular in musculoskeletal problems.
Category
Treatment - Other

2

Description
Control group: this group received 3 daily therapeutic exercises (three times a day with 10 repetition) plus 5 sessions placebo kinesiotape.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arman Shayan Rehabilitation Center
Full name of responsible person
Shabnam Shahali
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Iran, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 5555 5059
Email
shahali.sh@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86709
Email
alikarami11pt@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Private
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
Iran University of Medical Sciences
Full name of responsible person
Shabnam shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
shahali.sh@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabnam shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
shahali.sh@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabnam shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
shahali.sh@iums.ac.ir

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
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