Back to resultsShock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis (Shockwave)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radial extracorporeal shock wave
iontophoresis
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology
- Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .
- Tenderness on medial tibial plateau
- Intensity of pain: visual analogue scale equal to 5 or greater
- Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)
Exclusion Criteria:
- Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
- Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee
- history of previous knee surgery -
Sites / Locations
- Faculty of physical therapy ,Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Shock wave(A)
Iontophoresis (B)
Control (C)
Arm Description
subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise
subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise
stregnthening exercise;straight leg raising exercisein which the patients were positioned in the crook lying position with the unexercised limb was the flexed one then the patients were asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were don ,Isometric quadriceps contraction (quadriceps drill) in full knee extension maintained for 5 seconds, followed by a 5-second rest; the exercise was performed for 20 repetitions per session .treatment once per week for four weeks
Outcomes
Primary Outcome Measures
visual analogue scale (VAS)
pain intensity will be assessed by using visual analogue scale
Secondary Outcome Measures
knee range of motion (ROM)
electronic geniometer
knee injury and osteoarthritis outcome score physical function short (KOOS-PS)
knee function by using KOOS-PS questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04731350
Brief Title
Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis
Acronym
Shockwave
Official Title
Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shock wave(A)
Arm Type
Experimental
Arm Description
subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise
Arm Title
Iontophoresis (B)
Arm Type
Experimental
Arm Description
subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise
Arm Title
Control (C)
Arm Type
Other
Arm Description
stregnthening exercise;straight leg raising exercisein which the patients were positioned in the crook lying position with the unexercised limb was the flexed one then the patients were asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were don ,Isometric quadriceps contraction (quadriceps drill) in full knee extension maintained for 5 seconds, followed by a 5-second rest; the exercise was performed for 20 repetitions per session .treatment once per week for four weeks
Intervention Type
Device
Intervention Name(s)
radial extracorporeal shock wave
Intervention Description
Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)
Intervention Type
Device
Intervention Name(s)
iontophoresis
Intervention Description
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
strengthening exercise
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
pain intensity will be assessed by using visual analogue scale
Time Frame
change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Secondary Outcome Measure Information:
Title
knee range of motion (ROM)
Description
electronic geniometer
Time Frame
change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Title
knee injury and osteoarthritis outcome score physical function short (KOOS-PS)
Description
knee function by using KOOS-PS questionnaire
Time Frame
change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology
Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .
Tenderness on medial tibial plateau
Intensity of pain: visual analogue scale equal to 5 or greater
Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)
Exclusion Criteria:
Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee
history of previous knee surgery -
Facility Information:
Facility Name
Faculty of physical therapy ,Cairo University
City
Giza
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
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Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis
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