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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04731350
Other study ID # REC/012/002633
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2021
Est. completion date January 15, 2023

Study information

Verified date March 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.


Description:

60 subjects with grade II knee osteoarthritis will be recruited from outpatient clinic of faculty of physical therapy and then they will be assigned randomly by sealed envelope into three groups ;group A (shock wave group) will received radial extracorporeal shock wave ,group B (Iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be once session per week for four weeks .pain intensity ,knee ROM and knee injury and osteoarthritis outcome score physical function short (KOOS-PS).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 15, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 55 Years
Eligibility Inclusion Criteria: 1. Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology 2. Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray . 3. Tenderness on medial tibial plateau 4. Intensity of pain: visual analogue scale equal to 5 or greater 5. Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) Exclusion Criteria: 1. Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months 2. Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee 3. history of previous knee surgery -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
radial extracorporeal shock wave
Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)
iontophoresis
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
Other:
Exercise
strengthening exercise

Locations

Country Name City State
Egypt Faculty of physical therapy ,Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analogue scale (VAS) pain intensity will be assessed by using visual analogue scale change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Secondary knee range of motion (ROM) electronic geniometer change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Secondary knee injury and osteoarthritis outcome score physical function short (KOOS-PS) knee function by using KOOS-PS questionnaire change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
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