Knee Arthritis OsteoarthritisNCT07666061
Laser vs Lontophoresis in KOA
A study testing Low-Level Laser Therapy, Iontophoresis and Conventional Physical Therapy Only in people with Knee Arthritis Osteoarthritis, run by Kafrelsheikh University.
Trial summary
This randomized controlled trial aims to compare the effectiveness of laser therapy and iontophoresis in patients with knee osteoarthritis. The study will evaluate pain reduction, functional improvement, and knee joint mobility following Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- Low-Level Laser Therapy, Iontophoresis and Conventional Physical Therapy Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * Age 45-65 years.
- Diagnosed primary knee osteoarthritis (Grade I-II).
- Both genders.
- Ability to follow treatment protocol.
Who cannot join
- * Previous knee surgery.
- Intra-articular injections within last 6 months.
- Pacemaker.
- Skin lesions at treatment area.
- Severe neurological or cardiovascular disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Laser Therapy Versus Lontophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of laser therapy and iontophoresis in patients with knee osteoarthritis. The study will evaluate pain reduction, functional improvement, and knee joint mobility following
Read the detailed description
Participants will be randomly assigned into three groups receiving either laser therapy plus conventional physiotherapy, iontophoresis plus conventional physiotherapy, or conventional physiotherapy alone. Outcome measures will be assessed before and after treatment
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- Low-Level Laser Therapy, Iontophoresis, Conventional Physical Therapy Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyDevice
Low-level laser therapy combined with conventional physical therapy for patients with knee osteoarthritis to reduce pain and improve functional mobility and knee joint range of motion
IontophoresisDevice
Iontophoresis using dexamethasone combined with conventional physical therapy for patients with knee osteoarthritis to reduce pain and improve physical function and knee joint mobility
Conventional Physical Therapy OnlyOther
Conventional physical therapy program for patients with knee osteoarthritis including therapeutic exercises, stretching, strengthening exercises, and pain relief modalities to improve knee function and mobility.
| Study group | Role | What they receive |
|---|---|---|
| Group A: | Active comparator | Low-Level Laser Therapy Receives: Device: Low-Level Laser Therapy; Other: Conventional Physical Therapy Only |
| Group B | Active comparator | Iontophoresis Receives: Device: Iontophoresis; Other: Conventional Physical Therapy Only |
| Group C | Active comparator | Conventional Physical Therapy Only Receives: Other: Conventional Physical Therapy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using Visual Analogue Scale (VAS)
Measured: Baseline and after 4 weeks of treatment
Functional disability measured using WOMAC.
Measured: Baseline and after 4 weeks of treatment
3. Knee Range of Motion (ROM).
Measured: Baseline and after 4 weeks of treatment
Secondary outcomes (3)
Change in physical function assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
The WOMAC Physical Function Subscale consists of 17 items assessing difficulty in performing daily activities. Scores range from 0 to 68, with higher scores indicating worse physical function.
Measured: Baseline (Day 0) and Week 4
2. Reduction of joint stiffness.
Measured: Baseline and after 4 weeks of treatment
Change in daily activities performance assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
The WOMAC Physical Function Subscale consists of 17 items assessing difficulty in activities of daily living. Scores range from 0 to 68, with higher scores indicating worse functional limitation.
Measured: Baseline (Day 0) and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulaziz Fahad Ahmed Alsulaimani, Kafrelsheikh University
- Investigators
- hane mohamed hamed, PHD, Study chair, professor of orthopedic surgery depaetment of orthopedic surgery faculty of medicine kafrelsheikh universitymahmoud mohamed ewida, PHD, Study chair, professor of basic sciences for physical therapy department of basic sciences for physical therapy faculty oh physical therapy kafrelsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666061
- Sponsor's protocol ID
- KFSIRB200-1047
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Laser Therapy Versus Lontophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07666061
- Acronym / sponsor ID
- KFSIRB200-1047
- Conditions
- Knee Arthritis Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
This randomized controlled trial aims to compare the effectiveness of laser therapy and iontophoresis in patients with knee osteoarthritis. The study will evaluate pain reduction, functional improvement, and knee joint mobility following
Detailed description
Participants will be randomly assigned into three groups receiving either laser therapy plus conventional physiotherapy, iontophoresis plus conventional physiotherapy, or conventional physiotherapy alone. Outcome measures will be assessed before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: | Active comparator | Device: Low-Level Laser Therapy, Other: Conventional Physical Therapy OnlyLow-Level Laser Therapy |
| Group B | Active comparator | Device: Iontophoresis, Other: Conventional Physical Therapy OnlyIontophoresis |
| Group C | Active comparator | Other: Conventional Physical Therapy OnlyConventional Physical Therapy Only |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- * Age 45-65 years.
Key exclusion criteria (5 listed)
- * 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 |
|---|---|---|
| Low-Level Laser TherapyLow-level laser therapy combined with conventional physical therapy for patients with knee osteoarthritis to reduce pain and improve functional mobility and knee joint range of motion | Device | Group A: |
| IontophoresisIontophoresis using dexamethasone combined with conventional physical therapy for patients with knee osteoarthritis to reduce pain and improve physical function and knee joint mobility | Device | Group B |
| Conventional Physical Therapy OnlyConventional physical therapy program for patients with knee osteoarthritis including therapeutic exercises, stretching, strengthening exercises, and pain relief modalities to improve knee function and mobility. | Other | Group A:, Group B, Group C |
Primary outcome
Pain intensity measured using Visual Analogue Scale (VAS)
Time frame: Baseline and after 4 weeks of treatment
Functional disability measured using WOMAC.
Time frame: Baseline and after 4 weeks of treatment
3. Knee Range of Motion (ROM).
Time frame: Baseline and after 4 weeks of treatment
3 secondary outcomes
Change in physical function assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
Time frame: Baseline (Day 0) and Week 4
2. Reduction of joint stiffness.
Time frame: Baseline and after 4 weeks of treatment
Change in daily activities performance assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
Time frame: Baseline (Day 0) and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
hane mohamed hamed, PHD study chair
professor of orthopedic surgery depaetment of orthopedic surgery faculty of medicine kafrelsheikh university
mahmoud mohamed ewida, PHD study chair
professor of basic sciences for physical therapy department of basic sciences for physical therapy faculty oh physical therapy kafrelsheikh university
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy, Iontophoresis and Conventional Physical Therapy Only in people with Knee Arthritis Osteoarthritis, run by Kafrelsheikh University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact abdulaziz fahad alsulaimani, MASTER (966566613748, azoztaif88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured using Visual Analogue Scale (VAS) (time frame: Baseline and after 4 weeks of treatment). The study lists 3 primary outcomes in all. 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 24 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.