Knee OsteoarthritisShockwaveNCT04731350
Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis
A study testing radial extracorporeal shock wave, iontophoresis and Exercise in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- radial extracorporeal shock wave, iontophoresis and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Knee Osteoarthritis
- Being tested
- radial extracorporeal shock wave, iontophoresis, Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial extracorporeal shock waveDevice
Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)
iontophoresisDevice
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
ExerciseOther
strengthening exercise
| Study group | Role | What they receive |
|---|---|---|
| Shock wave(A) | Experimental | 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 Receives: Device: radial extracorporeal shock wave; Other: Exercise |
| Iontophoresis (B) | Experimental | subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise Receives: Device: iontophoresis; Other: Exercise |
| Control (C) | Other | 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 Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
pain intensity will be assessed by using visual analogue scale
Measured: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Secondary outcomes (2)
knee range of motion (ROM)
electronic geniometer
Measured: 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
Measured: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start20 Jan 2021
- Primary completion1 Nov 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Abu El Kasem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731350
- Sponsor's protocol ID
- REC/012/002633
- Acronym
- Shockwave
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04731350
- Acronym / sponsor ID
- Shockwave / REC/012/002633
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Shock wave(A) | Experimental | Device: radial extracorporeal shock wave, Other: Exercisesubjects 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 |
| Iontophoresis (B) | Experimental | Device: iontophoresis, Other: Exercisesubjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise |
| Control (C) | Other | Other: Exercisestregnthening 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 |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radial extracorporeal shock waveRadial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland) | Device | Shock wave(A) |
| iontophoresisIontophoretic drug delivery system (phoresors II auto model PM850 IOMED): | Device | Iontophoresis (B) |
| Exercisestrengthening exercise | Other | Control (C), Iontophoresis (B), Shock wave(A) |
Primary outcome
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
2 secondary outcomes
knee range of motion (ROM)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial extracorporeal shock wave, iontophoresis and Exercise in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: change from baseline to immediately pre treatment and from pre treatment to immediately post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.