Protocol summary

Study aim
Investigation of the synergistic effects of multiple drilling and magneto-therapy on reduction of complaints in patients with knee osteochondritis dissecan.
Design
A single-blinded, controlled clinical trial with factorial groups design of 36 patients.
Settings and conduct
32 patients in age group 18 to 50 years, with grade I, II knee osteochondritis dissecan are studied in three groups of surgery (intervention 1), surgery + magnet-therapy (intervention 2) and control in Ahvaz Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients with grade I, II knee osteochondritis dissecan, based on Dipaola classification system and age range of 18 to 45 years; The exclusion criteria are patients with history of ligament or meniscus injury, fracture history in the last 4 weeks, morphine consumption more than 3 months, osteoarthritis, history of surgery around the knee, history of intra-articular knee injection in the last 6 months and patient with impaired musculoskeletal function.
Intervention groups
In the Intervention group (1), surgical treatment is performed with multiple drilling technique. In the Intervention group (2), in addition to surgical treatment, 3 days after surgery, for 20 sessions and 6 days a week, patients will be exposed with a pulsed electromagnetic field with a frequency of 20 Hz and intensity of 4.5 mT. In the control group, patients are prescribed Nonsteroidal anti-inflammatory drugs (NSAIDs) for one month along with 15 sessions of physiotherapy in the form of isometric exercises and adjustment of daily activities.
Main outcome variables
Pain score, functional level, knee injury outcome and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200819048462N1
Registration date: 2020-08-30, 1399/06/09
Registration timing: registered_while_recruiting

Last update: 2020-08-30, 1399/06/09
Update count: 0
Registration date
2020-08-30, 1399/06/09
Registrant information
Name
Samaneh Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
rashidi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Synergistic Effects of Multiple Drilling and Magneto-therapy on Reduction of Complaints in Patients with Knee Osteochondritis Dissecan.
Public title
Investigation of the synergistic effects of Multiple Drilling and Magneto-therapy on Knee Osteochondritis Dissecan.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade I, II knee osteochondritis dissecan, based on Dipaola classification system Patients with age range of 18 to 45 years
Exclusion criteria:
History of ligament or meniscus injury that has caused a major problem for the patient. Fracture history in the last 4 weeks. Morphine consumption for more than 3 months. Osteoarthritis caused by inflammatory diseases including rheumatoid arthritis (RA), gout, Chondrocalcinosis and... History of any surgery around the knee. History of intra-articular knee injection in the last 6 months. The patient has severe pain or dysfunction.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Responsible person for data collection and data analyzer will be unaware of how patients are grouped to prevent personal opinion.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.AJUMS.REC.1396.906

Health conditions studied

1

Description of health condition studied
Knee Osteochondritis Dissecan
ICD-10 code
M93.2
ICD-10 code description
Osteochondritis dissecans

Primary outcomes

1

Description
Pain
Timepoint
Before any intervention (surgical or pharmaceutical), 3 and 6 months after the first evaluation
Method of measurement
Visual Analogue Scale (VAS) (0 to 10)

2

Description
Functional level
Timepoint
Before any intervention (surgical or pharmaceutical), 3 and 6 months after the first evaluation
Method of measurement
According to grading the Tegner Lysholm knee scoring scale

3

Description
Knee injury and osteoarthritis outcome
Timepoint
Before any intervention (surgical or pharmaceutical), 3 and 6 months after the first evaluation
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS)

4

Description
Quality of life
Timepoint
Before any intervention (surgical or pharmaceutical), 3 and 6 months after the first evaluation
Method of measurement
The 36-item short form health survey questionnaire (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (1): Surgical treatment is performed with multiple drilling technique. The multiple drilling technique was performed using a suction hemovac drain needle, and 4 to 6 weeks after surgery, the knee movement was limited by a brace to control the range of motion and prevent collision of the femoral and tibial condyles.
Category
Treatment - Surgery

2

Description
Intervention group (2): In addition to surgical treatment with multiple drilling technique, 3 days after surgery, for 20 sessions and 6 days a week, patients will be exposed with a pulsed electromagnetic field with a frequency of 20 Hz and intensity of 4.5 mT.
Category
Treatment - Devices

3

Description
Control group: Patients are prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) for one month along with 15 sessions of physiotherapy in the form of isometric exercises and adjustment of daily activities.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Fakoor
Street address
Orthopedic Department, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
dr_m_fakoor@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Rashidi
Position
Medical physicists
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Magnet therapy Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
samanehrashidi92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Rashidi
Position
medical physicists
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Magnet therapy Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
samanehrashidi92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Rashidi
Position
Medical physicists
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Magnet therapy Clinic, Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 0168
Email
samanehrashidi92@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Loading...