Protocol summary

Summary
Introduction: Knee osteoarthritis (KOA) is the most common cause of chronic disability among the elderly. Due to importance of the knee joint in weight-bearing and walking, people with knee osteoarthritis often experience limitations in daily activities. Various treatment methods are recommended for management of knee osteoarthritis. In this study, two methods of ‘interferential’ and ‘interferential plus exercise-therapy’ were compared. Methods and materials: This study was conducted on 32 patients with KOA aged 45- 65 years with at least six months of complaint about knee pain. After convenient sampling, patients were randomly divided into two groups: group І (interferential plus exercise-therapy) and group II (interferential). Both groups were treated in 8 treatment sessions. Pain intensity and functional status were evaluated by Numeric Rating Scale (NRS) and Western Ontario and McMaster Universities osteoarthritis index questionnaire (WOMAC), respectively. Statistical analysis was done using Wilcoxon Signed Rank Test to compare before and after intervention in each group and Mann-Whitney Test for between-groups comparison. Results: Improvement in group І in pain intensity (NRS), knee flexion ROM, strength of knee extensor muscles and WOMAC questionnaire criteria was significantly higher than that in group II (p<0.05) but there was no significant difference between the two groups in knee extension ROM and strength of knee flexor muscles (p>0.05). Discussion & Conclusion: Our results indicated that both interferential and exercise-therapy can improve patients with KOA. It is concluded that interferential therapy alone can be somewhat effective in reducing pain and improving function in patients with KOA, however to achieve maximum recovery in these patients, exercise-therapy plays a key role.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021624149N26
Registration date: 2016-04-26, 1395/02/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
This research was performed as a thesis, financially supported by Shiraz University of Medical Sciences (Shiraz, Iran)
Expected recruitment start date
2012-01-11, 1390/10/21
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISON OF THE THERAPEUTIC EFFECT OF INTERFERENTIAL CURRENT STIMULATION ALONE AND COMBINED WITH EXERCISE-THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS
Public title
THE THERAPEUTIC EFFECT OF INTERFERENTIAL CURRENT AND EXERCISE-THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were the age between 45 and 65 years, bilateral knee pain lasting at least for 6 months, morning stiffness lasting more than 30 minutes, crepitation during active knee movements and radiographic findings of KOA (such as joint space narrowing and osteophyte) Patients with the history of intra-articular steroid injection in the previous 6 months, and fracture, arthroplasty or surgery in the lower limbs were excluded from this study, as were subjects with cardio-pulmonary dysfunction, malignancy, lower limb’s acute inflammatory conditions and radicular pain, patients with rheumatoid arthritis (RA) and patients who had received physiotherapy treatments at the previous four months
Age
From 45 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 32
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
ethics committee of shiraz university of medical sciences
Street address
zand st
City
shiraz
Postal code
Approval date
2011-10-30, 1390/08/08
Ethics committee reference number
ct-90-5780

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain intensity
Timepoint
before and after intervention
Method of measurement
numeric rating scale (NRS)

Secondary outcomes

1

Description
functional activities
Timepoint
before and after intervention
Method of measurement
WOMAC quastionaire

Intervention groups

1

Description
1- interferential + exercise therapy 2- exercise therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
shiraz university of medical sciences - rehabilitation school
Full name of responsible person
Fahimeh Kamali
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
student research committee of shiraz university of medical sciences
Full name of responsible person
Fahime Kamali
Street address
shiraz university of medical sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
student research committee of shiraz university 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
shiraz university of medical sciences
Full name of responsible person
saba salemi
Position
sport physiotherapy MS
Other areas of specialty/work
Street address
baharestan sq- shafa hospital
City
Tehran
Postal code
Phone
+98 21 3351 0979
Fax
Email
genius_67_66@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shiraz university of medical sciences
Full name of responsible person
fahimeh kamali
Position
Phd physiotherapy
Other areas of specialty/work
Street address
abiverdi st
City
shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Fahimeh Kamali
Position
Phd physiotherapy
Other areas of specialty/work
Street address
abiverdi st
City
shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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