The evaluation of the ginger extract gel(ZingiberOfficinale) phonophoresis and pulsed ultrasound on the knee pain and function in patients with moderate degree of knee osteoarthritis
Objectives: Osteoarthritis is a common joint inflammatory disease with symptoms like joint stiffness and decreased performance. Knee osteoarthritis prevalence is estimated as 34.19% in Iran. Different physical therapy methods like ulstrasound therapy and phonophoresis are used to reduce pain and inflammation. Ginger had been proved to reduce pain and improve performance in patients with knee osteoarthritis in the previous studies. No previous study has evaluated the effects of ginger phonophoresis;so, the aim of this study is to evaluate ginger effects.
Design: Randomised Controlled Trial
Setting and conduct: Intervention and control groups receive 10 sessions of routine physical therapy but control group receive just ultrasound. Intervention group receive ginger phonophoresis.
Participants:Patients diagnosed as knee osteoathritis with specialist and according to Kelegren-Lawrence method and age beyond 50 years old were assigned into interventional and control groups.
Intervention: Intervention group: Hot pack- TENS- Exercise- Ginger phonophoresis
Control group: Hot pack- TENS- Exercise- US
Main outcome measures variables: Pain (VAS)- KOOS questionnaire- TUGT
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061428447N1
Registration date:2016-07-31, 1395/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-31, 1395/05/10
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1081
Email address
yoosefinejad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of medical sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the ginger extract gel(ZingiberOfficinale) phonophoresis and pulsed ultrasound on the knee pain and function in patients with moderate degree of knee osteoarthritis
Public title
the effects of a physical therapy method on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Knee osteoarthritis confirmed with a specialist according to Kelegren-Lawrens method; age beyond 50 years old
-Exclusion criteria:
Arthroscopy during the last year; Fever over 38 degrees centigrade; Hyulorunate injection during previous 6 months; anticoagulants like aspirin; coagulation and blood diseases like hemophilia; deformities;Lower limb surgery during previous 6 months; systematic disorders as diabtes mellitus; inflammatory arthropaties;
soft tissue rheumatism; Inflammatory conditions;Skin sensation disorders; Skin ulcers.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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 of Shiraz University of medical sciences
Street address
Shiraz, Nemazi Street, Central building of Shiraz university of medical scinces
City
Shiraz
Postal code
14336 - 71348
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.SUMS.REC.1395.53
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M15
ICD-10 code description
Primary generalized (osteo)arthrosis
Primary outcomes
1
Description
knee performance
Timepoint
before, after the intervention
Method of measurement
Persian version of KOOS questionnaire
Secondary outcomes
1
Description
pain
Timepoint
before and after the intervention
Method of measurement
VAS scale
Intervention groups
1
Description
intervention group: hot pack for 20 minutes; TENS for 20 minutes with 100 Hz of frequency and 100 ms duration; Phonophoresis of Zingiber Officinale with 4% concentration, 5 days per weak, 10 days and 7 minutes of application
Category
Treatment - Other
2
Description
Control group: Hot pack for 20 minutes; TENS for 20 minutes with 100 Hz frequency and 100 ms duration; ultrasound in continuous mode for 7 minutes, 5 days a weak for 10 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
school of rehabilitation of Shiraz university of medical sciences