- To determine and compare the mean pain, effusion and range of motion in patients with anterior knee pain before treatment , after 5 sessions treatment , after 10 sessions treatments and after one month follow-up in high voltage pulse current and control groups.
Design
Randomized controlled clinical trial with factorial groups and double blinded
Settings and conduct
The rationale for this research is to determine the effects of high voltage pulse current on pain, range of motion and effusion in patients with anterior knee pain. This will done in poursina hospital and neither patients no examiner know the grouping and treatments procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 16 to 60 years. Anterior knee pain and effusion diagnosis: According to orthopedic physician assessment; Exclusion criteria: Patients with anterior knee pain without effusion . Patients with arthrosis grade III and IV according to X-Ray. Patients with tibia, patella, femur and fibula fractures. Patients with history of femur and other bones surgery, or meniscus and cruciate ligaments and tendon surgery. Patients with complete soft tissues tear such as meniscus and cruciate ligaments. Patients with referral pain form lumbar or hip and local infections. Addict or pregnant individuals. Patients that took part in physiotherapy program about during 2 weeks ago. Patients with history of rheumatoid diseases such as rheumatoid arthritis.
Intervention groups
Control group receive routine physical therapy treatments and intervention group receive routine physical therapy as well as high voltage pulse current
Main outcome variables
Knee pain
Knee effusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N3
Registration date:2018-04-21, 1397/02/01
Registration timing:prospective
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Kamran Ezzati
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
kamranezzati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of high voltage pulse current on pain, effusion and range oh motion in subjects with anterior knee pain
Public title
The effects of high voltage pulse current on pain, effusion and range oh motion in subjects with anterior knee pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior knee pain and effusion diagnosis: According to orthopedic physician assessment
The patients with knee effusion affected by patellofemoral pain syndrome or osteoarthritis grade I and II without complete tear of soft tissues.
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The grouping method will be Permuted block randomization . So, blocks of 10 people including 5 participants in the intervention group and 5 participants in the control group are allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner won't know anything about the kind of treatment. The Patients and therapists will also not know anything about grouping and kind of interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی گیلان
Street address
5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۳۷۱۳۱۹۴
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.GUMS.REC.1397.3
Health conditions studied
1
Description of health condition studied
Anterior knee pain
ICD-10 code
M19.0
ICD-10 code description
Arthrosis
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Effusion score
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
Tape
2
Description
Range of Motion
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
Goniometer
Intervention groups
1
Description
Control group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with transcutaneous electrical nerve stimulation(TENS) type brief for 20 minutes. In this method, four electrodes on the sides of the knee will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily.
Category
Rehabilitation
2
Description
Intervention group: Intervention group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily. 4. high voltage pulse current: In this study, Four electrodes from proximal to distal of the knee joint will be placed with intermittent polarity. The treatment time will be 20 min for each patient. Minimal scene of electrical stimulation is perceived by the patients.