Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis (Shockwave)

Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: radial extracorporeal shock wave; Other: Exercise; Device: iontophoresis

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 002
    • faculty of physical therapy ,Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shock wave(A); 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	Device: radial extracorporeal shock wave; Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland); Other: Exercise; strengthening exercise
Experimental: Iontophoresis (B); subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise	Other: Exercise; strengthening exercise; Device: iontophoresis; Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
Other: Control (C); 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	Other: Exercise; strengthening exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee range of motion (ROM)	electronic geniometer	change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: REC/012/002633

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No