1. Home
  2. Approved trials
  3. » فارسی

Clinical Trial to comparison the effectiveness of Extra Corporal Shock Wave Therapy and other conventional physiotherapy interventions on the amount of knee pain in patients With Moderate knee Osteoarthritis

Protocol summary

Summary
This study aimed to compare the effectiveness of shock wave therapy with other conventional physiotherapy interventions on the amount of pain in patients with Moderate Knee Osteoarthritis referred to Shohada Hospital of Tabriz. In this study 120 patients at the age of 50-70 years old with Moderate Knee Osteoarthritis, diagnosed based on clinical and radiological examinations, will participate. Patients with rheumatic disease, cardiac conduction block, epilepsy, deep vein thrombosis, pregnancy, and any contraindication for modalities, and patients who had past medical history of surgery, fractures, injections and wound at the knee joint region will be excluded. Patients will be selected randomly using sealed envelope and assigned into 3 groups including control, intervention 1 and intervention 2 groups .At first, VAS scale, WOMAC questionnaire and TUG test will be filled out for all patients and knee joint range of motion and HSCRP blood level will be evaluated for them. Control group will receive just exercise program. Intervention 1 group will receive shock wave therapy for 5 sections during 3 weeks with moderate energy plus the exercise programs as well as control group. Intervention 2 group will receive conventional physiotherapy such as Hot Pack and TENS and Ultra Sound for ten sections in addition to the exercise programs as well as control group. Strengthening exercise for the Quadriceps muscles, isometric exercise with or without weight, and weight bearing exercise inside and outside of water will be done for all patients. Life style modification education will be done for all patients. The amount of pain as primary out come and range of motion and knees function and level of HSCRP as secondary out comes will be assessed. All above variables will be reevaluated after 3 and 7 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608044641N12
Registration date: 2017-02-06, 1395/11/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Tabriz University of Medical Sciences; Research Center of Tabriz Physical Medicine and Rehabilitation.
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial to comparison the effectiveness of Extra Corporal Shock Wave Therapy and other conventional physiotherapy interventions on the amount of knee pain in patients With Moderate knee Osteoarthritis
Public title
Effectiveness of Extra corporal Shock Wave therapy in the treatment of Knee Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with moderate knee osteoarthritis grade 2 and 3, based on kellegren &Lawrence scale; patients at the age of 50-70 years. Exclusion criteria: patients with rheumatologic disorders such as rheumatoid arthritis; past medical history of surgery on knee joints; past medical history of fracture in lower limbs with involvement of articular surface of knees; mild and sever knee osteoarthritis ( 1 and 4 radiological scale); patients with electrical implants such as pace makers; past medical history of conduction block cardiac disease; patients with epileptic disorders; patients with pregnancy; patients with deep vein thrombosis; past medical history of intra-articular injections since 6 month ago and systemic corticosteroid drugs consumption since 1 month ago; patients with balance disturbance; patients with neuropathy and sensory impairments; existence of any skin lesions around the knee joints; BMI above 30; patients who are unable to complete the questionnaire and procedures.
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
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 comittee of Tabriz University of Medical Sciences
Street address
Central building number2 (third floor), Tabriz University of Medical Sciences, Golgasgt street,Tabriz.
City
Tabriz
Postal code
5166614756
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.288

Health conditions studied

1

Description of health condition studied
Moderate knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]

Primary outcomes

1

Description
The amount of Pain
Timepoint
Time zero(baseline), 3weeks later,7 weeks later.
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Knee range of motin
Timepoint
Time zero (baseline),3weeks later,7 weeks later.
Method of measurement
Goniometer.

2

Description
knee function
Timepoint
Time zero (baseline),3weeks later,7 weeks later.
Method of measurement
WOMAC questionnaire

3

Description
HSCRP level
Timepoint
Time zero (baseline),final evaluation at week 7.
Method of measurement
laberatory kit

Intervention groups

1

Description
The control group will receive just exercise programs. Exercise program consists of strengthening exercise for quadriceps muscle, Isometric exercise with and without weight, weight bearing exercise inside and outside the water.
Category
Other

2

Description
Intervention group 1: The patients will receive Shock Wave Therapy for the affected knee at the site with maximum pain amount in sitting position, flexion of knee joint and abduction and external rotation of hip joint, during 3 weeks; 2000 shock/session; 5 session; energy level 2-4; pulse rate 160/min; 6-10 Hz; density 0.18 mj/mm2; with zimmer shokwave device, made in Germany
Category
Other

3

Description
Group intervention 2:The patients will receive conventional physiotherapy interventions for 10 sessions which is consisted of 1) Hot Pack at 74.5 degrees centigrade for 20 minutes, at the knee region with maximum pain; and 2) TENS: pulse duration 20-100 Microsecond; 50% duty cycle; continuous amplitude at the maximum pain region of affected knee; frequency<200pps, and 3) Ultra Sound: 1MHz Frequency; intensity of 2.5 W/cm2; pulse at duty cycle of 25%; for 10 minute.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada hospital, Tabriz University of Medical Scienc
Full name of responsible person
Razieh ahmadi
Street address
Shohada Hospital( Physical medicine and rehabilitation ward),Golshahr street, Tabriz.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Research Center of Tabriz
Full name of responsible person
Dr Seyed Kazem Shakori,MD
Street address
Eemam Reza Hospital(Physical Medicine and Rehabilitation,Research Center), Golgasht street, Tabriz.
City
Tabriz
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Research Center of Tabriz
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
Tabriz University of Medical Science
Full name of responsible person
Dr Razieh Ahmadi
Position
Resident in training
Other areas of specialty/work
Street address
Emam Reza Hospital, Golgasht street,Tabriz .
City
Tabriz
Postal code
5166614756
Phone
+98 41 3337 3967
Fax
Email
ahmadi.dr62@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Bina Eftekhar Sadat
Position
Associate Professor.
Other areas of specialty/work
Street address
Emam Reza Hospital, Golgasht street, Tabriz.
City
Tabriz
Postal code
5166614756
Phone
+98 41 3337 3967
Fax
Email
binasadat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr Razieh Ahmadi
Position
Clinical Assistant
Other areas of specialty/work
Street address
Emam Reza Hospital, Golgasht street, Tabriz.
City
Tabriz
Postal code
51666614756
Phone
+98 41 3337 3967
Fax
Email
ahmadi.dr62@gmail.com
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
Loading...