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

March 5, 2023 updated by: Shimaa Taha Abu El Kasem, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 002
        • Faculty of Physical Therapy ,Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
visual analogue scale (VAS)
Time Frame: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee range of motion (ROM)
Time Frame: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
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)
Time Frame: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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