Objective: To determine the effects of knee taping in combination with exercise and medical treatment on functional outcome of patients with knee osteoarthritis.
Methods: In a randomized single-blinded clinical trial, 36 patients with knee osteoarthritis were randomly assigned to two study groups. Both groups received exercise and medical therapy for 6 weeks. In addition, the case group (20 patients) received taping in the first 3 weeks. Pain severity (assessed by visual analogue scaling), weekly amount of analgesics consumption, timed get Up and Go test (TUG) and step tests were recorded at baseline, 3 and 6 weeks after the treatment and were further compared between two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041021673N1
Registration date:2015-04-30, 1394/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-30, 1394/02/10
Registrant information
Name
Mahboobeh Mashayekhi Asl
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3443 9361
Email address
h.ghasemi@eng.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Taping on Pain and Functional Outcome in Patients with Knee Osteoarthritis
Public title
effectiveness of taping in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: knee OA with radiological grade I,III or III (based on Kellgren-Lawrence grading scale); no presence of any inflammatory arthritis; no history of any injection at knee or any surgical intervention in this part within the last 6-month; no suspicion to other pathologies in the knee; not severe obesity; no instability of the knee joint; no cardiovascular disorders (due to cardiovascular side-effect of celecoxib); no trauma to the knee during the study;
Exclusion criteria: allergic reaction to tape or any skin problem that prevents the tape; not following the treatment by patients; performing physiotherapy within treatment schedule
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Daneshgah st.
City
Isfahan
Postal code
Approval date
2014-05-14, 1393/02/24
Ethics committee reference number
393450
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
pain
Timepoint
0-3w-6w
Method of measurement
VAS Score
2
Description
Timed Up and Go
Timepoint
0-3w-6w
Method of measurement
The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again
3
Description
step test
Timepoint
0-3w-6w
Method of measurement
The Step Test involves stepping one foot on, then off, a block as quickly as possible in 15 seconds.
Secondary outcomes
1
Description
weekly mean of analgesics consumption
Timepoint
0-3w-6w
Method of measurement
mean number of Celecoxib 100mg capsules consumpted at last week
Intervention groups
1
Description
control: cap celecoxib 100mg, 1-3 capsules per day (based on pain severity)
Category
Treatment - Drugs
2
Description
control: exercise(stretching for hamstring and calf muscle and strengthening for quadriceps femoris)
Category
Rehabilitation
3
Description
intervention:
exercise(stretching for hamstring and calf muscle and strengthening for quadriceps femoris)
Category
Rehabilitation
4
Description
intervention :
cap celecoxib 100mg 1-3 daily(based on pain severity)
Category
Treatment - Drugs
5
Description
intervention:
knee taping
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mahboobeh Mashayekhi Asl M.D.
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl M.D.
Street address
Daneshgah st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Univercity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl
Position
Resident, Phisycal Medicine and Rehabilitation
Other areas of specialty/work
Street address
Phisycal Mmedicine and Rrehabilitation, Medical Department, Isfahan University of Medical Sciences, daneshgah St.
City
Isfahan
Postal code
Phone
+98 31 3443 9361
Fax
Email
m.mashayekhi.asl@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl M.D.
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation, Medical Department, Isfahan University of Medical Sciences, Daneshgah st.
City
Isfahan
Postal code
Phone
+98 31 3443 9361
Fax
Email
m.mashayekhi.asl@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Mashayekhi Asl M.D.
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation, Medical Department, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3443 9361
Fax
Email
m.mashayekhi.asl@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)