Knee Arthritis OsteoarthritisHILT-CM (KOA)NCT07551245
Knee Osteoarthritis Rehab: High-Intensity Laser vs Classical Modalities
A study testing High-Intensity Laser Therapy (HILT) and Conventional Physical Therapy Modalities in people with Knee Arthritis Osteoarthritis, run by Erbil Polytechnic University at 1 site in Iraq.
Trial summary
This study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- High-Intensity Laser Therapy (HILT) and Conventional Physical Therapy Modalities
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 20 Apr 2026to 20 Jan 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of Knee Osteoarthritis: Patients must have a clinical and radiographic diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria, including evidence of joint space narrowing, osteophyte formation, and other degenerative changes observed on X-rays or MRI.
- Age: Adults aged between 40 and 75 years. Willingness to Participate: Participants must provide informed consent and be willing to adhere to the study protocol, including attending all treatment sessions and follow-up assessments.
- Kellgren-Lawrence Grade: Patients with knee OA grades 1-3 (mild to moderate OA).
Who cannot join
- Contraindications to Laser Therapy:
- Active malignancy History of epilepsy Photosensitivity disorders Active infection in the treatment area
- Surgical History:
- Patients who have undergone knee surgery within the past 6 months Scheduled surgery during the study period
- Advanced Disease:
- Kellgren-Lawrence Grade 4 (severe OA) where surgical intervention is indicated
Show all 10Show fewer
- Pregnancy or Lactation:
- Pregnant or lactating women
- Severe Comorbidities:
- Uncontrolled diabetes Severe cardiovascular disease Neurological disorders that might interfere with participation or affect treatment outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Aylan Center
Erbil, Erbil Governorate, 44001
Mahdi Qadir, PhD, 07504631542, mahdiqader@epu.edu.iq
Ahmed bapir, PhD, 07507580043, ahmed.bapir@gmail.com
About this study
Official title: Rehabilitation of Knee Osteoarthritis by High Intensity Laser Therapy vs Classical Modalities
This study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Knee osteoarthritis is a common condition, especially in older adults, causing pain, stiffness, reduced movement, and difficulty performing daily activities. Current treatments focus on reducing pain and improving joint function.
In this study, 100 patients with knee osteoarthritis will be divided into two groups. One group will receive HILT combined with therapeutic exercises, while the other group will receive conventional physical therapy modalities along with the same exercises. The treatment outcomes will be evaluated over time.
Read more
The main outcomes include pain reduction (measured by pain scales such as WOMAC and VAS), improvement in joint function, and structural changes in the knee assessed by MRI. In addition, laboratory tests will be used to measure inflammation, cartilage health markers, and oxidative stress before and after treatment.
The goal is to determine whether HILT provides better pain relief, improves joint function, and is safe compared to standard therapy. The results may help improve rehabilitation strategies for patients with knee osteoarthritis.
Read the detailed description
Knee Osteoarthritis is a chronic degenerative joint disorder characterized by progressive cartilage loss, pain, stiffness, and functional limitation. It is a leading cause of disability, particularly among older adults, and its prevalence is increasing with population aging.
Non-surgical management is the first-line approach and includes exercise therapy and physical modalities aimed at reducing pain and improving joint function. High-Intensity Laser Therapy is a non-invasive modality that delivers high-energy light to tissues, promoting cellular activity, increasing adenosine triphosphate (ATP) production, enhancing microcirculation, and reducing inflammation and edema. In contrast, Low-Level Laser Therapy has been more extensively studied, while evidence regarding HILT remains limited.
This study is a randomized comparative trial designed to evaluate the efficacy and safety of HILT compared with conventional physical therapy modalities in patients with knee osteoarthritis. A total of 100 participants meeting the American College of Rheumatology criteria will be recruited from rheumatology and rehabilitation centers in Erbil, Iraq. Participants will be randomly assigned to one of two groups: (1) HILT combined with therapeutic exercise, or (2) conventional physical therapy modalities combined with therapeutic exercise.
The primary outcome is pain intensity at 4 weeks, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale or Visual Analogue Scale (VAS). Secondary outcomes include pain at 8 weeks and functional status. Structural joint changes will be evaluated using magnetic resonance imaging (MRI), including assessment of cartilage thickness, joint irregularity, effusion, and osteophyte formation.
Laboratory assessments will be conducted before and after intervention to evaluate biological effects. These include inflammatory markers (C-reactive protein), gene expression markers related to cartilage metabolism (TGFB1, FOXO1, COMP, and MMP3) measured by RT-PCR, and oxidative stress markers (malondialdehyde [MDA] and superoxide dismutase [SOD]) measured using ELISA.
Eligible participants are adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis who are able to provide informed consent and comply with study procedures. Exclusion criteria include contraindications to laser therapy (e.g., malignancy, epilepsy, photosensitivity, or local infection), recent knee surgery, advanced osteoarthritis requiring surgical intervention, pregnancy or lactation, and severe comorbid conditions that may affect participation or outcomes.
Data will be analyzed using Statistical Package for the Social Sciences (SPSS, version 21). Ethical approval will be obtained from the relevant institutional review bodies, and written informed consent will be obtained from all participants. Confidentiality will be maintained throughout the study.
This study aims to determine whether HILT provides superior clinical and biological outcomes compared with conventional physical therapy modalities in the management of knee osteoarthritis.
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- High-Intensity Laser Therapy (HILT), Conventional Physical Therapy Modalities
- Keywords
- LASER, knee OA, classical modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT)Device
Also called High Power Laser Therapy, Class IV Laser Therapy
High-Intensity Laser Therapy (HILT) combined with therapeutic exercise program.
HILT Specifications:
- Four-wavelength beam system for deep tissue penetration
- Continuous and modulating frequencies to promote pain control and healing
- SuperPulse mode for deeper therapeutic penetration
- High power output delivering larger doses with shorter treatment times
- Pre-programmed presets for consistent and safe treatment outcomes
Mechanism of Action:
HILT delivers high energy output into tissues, generating photochemical effects including:
- Increased mitochondrial oxidation and ATP production
- Enhanced blood circulation and metabolism
- Fast absorption of edema and removal of exudates
- Increased serotonin and endorphin levels
- Anti-inflammatory effects through reduced prostaglandin synthesis
- Decreased nerve cell membrane permeability for Na/K causing hyperpolarization
- Increased lymphatic flow
- Modulation of genetic markers: increased expression of cartilage protection biomarkers
Conventional Physical Therapy ModalitiesDevice
Also called Therapeutic Ultrasound, Microwave diathermy, Transcutaneous Electrical Nerve Stimulation (TENS), Deep heat Therapy
Classical Physical Modalities combined with therapeutic exercise program.
Modalities Include:
- Therapeutic Ultrasound and/or other conventional physical therapy modalities as per standard clinical practice for knee osteoarthritis
- Evidence-based parameters for knee OA treatment
Treatment Protocol:
- Duration: 8 weeks
- Combined with the same standardized therapeutic exercise program as the HILT group
- Sessions will be conducted at rheumatology and rehabilitation units in Erbil, Iraq
This represents the current standard of care for conservative management of knee osteoarthritis in physical medicine and rehabilitation settings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (HILT) | Experimental | Patients will receive High-Intensity Laser Therapy (HILT) combined with a standardized therapeutic exercise program. HILT parameters include four-wavelength beam, continuous/modulating frequencies, and SuperPulse mode for deep penetration. Receives: Device: High-Intensity Laser Therapy (HILT); Device: Conventional Physical Therapy Modalities |
| Classical Modalities | Active comparator | Patients will receive classical physical modalities (such as therapeutic ultrasound or TENS, as per standard local practice) combined with the same standardized therapeutic exercise program. Receives: Device: High-Intensity Laser Therapy (HILT); Device: Conventional Physical Therapy Modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (WOMAC Pain Subscale)
Pain intensity will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The WOMAC is a validated instrument that measures pain, stiffness, and physical function in patients with osteoarthritis. The pain subscale consists of 5 items scored on a 0-10 scale, with higher scores indicating more severe pain.
Measured: Baseline to 4 weeks post-treatment initiation
Secondary outcomes (1)
Change in Pain Intensity (Visual Analog Scale - VAS)
Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS) for global pain or walking pain. Patients mark their pain level on a 100 mm line where 0 represents "no pain" and 100 represents "worst pain imaginable."
Measured: Baseline to 4 weeks post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Apr 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- 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
- This is a randomized, parallel-group, open-label comparative study. Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups using simple randomization. Group 1 will receive High-Intensity Laser Therapy (HILT) plus therapeutic exercise, and Group 2 will receive classical physical modalities (ultrasound/TENS) plus therapeutic exercise. The study is unblinded (open-label) as the nature of the interventions makes blinding of participants and therapists impractical. However, outcome assessors for MRI evaluation will be blinded to group allocation. Treatment duration is 8 weeks with follow-up assessments at baseline, 4 weeks, and 8 weeks.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erbil Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdi Qadir, Erbil Polytechnic University
- Investigators
- Ahmed Bapir, PhD, Study director, EPU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551245
- Sponsor's protocol ID
- Erbil Polytechnic University
- Acronym
- HILT-CM (KOA)
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) protection of participant privacy and confidentiality in accordance with Iraqi health research regulations and institutional ethical guidelines; (2) the need to protect data integrity for ongoing PhD thesis completion and future publications; (3) local institutional policies regarding data sharing. De-identified summary data may be available from the principal investigator upon reasonable request and with appropriate data use agreements after completion of the PhD program and primary publications.
Publications
Igawa T, Katsuhira J. Biomechanical analysis of stair descent in patients with knee osteoarthritis. J Phys Ther Sci. 2014 May;26(5):629-31. doi: 10.1589/jpts.26.629. Epub 2014 May 29.
PubMed 24926119Manetta J, Franz LH, Moon C, Perell KL, Fang M. Comparison of hip and knee muscle moments in subjects with and without knee pain. Gait Posture. 2002 Dec;16(3):249-54. doi: 10.1016/s0966-6362(02)00009-7.
PubMed 12443949
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Knee Osteoarthritis by High Intensity Laser Therapy vs Classical Modalities
- ClinicalTrials.gov ID
- NCT07551245
- Acronym / sponsor ID
- HILT-CM (KOA) / Erbil Polytechnic University
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- LASER, knee OA, classical modalities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erbil Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 24 Apr 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 study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Knee osteoarthritis is a common condition, especially in older adults, causing pain, stiffness, reduced movement, and difficulty performing daily activities. Current treatments focus on reducing pain and improving joint function.
In this study, 100 patients with knee osteoarthritis will be divided into two groups. One group will receive HILT combined with therapeutic exercises, while the other group will receive conventional physical therapy modalities along with the same exercises. The treatment outcomes will be evaluated over time.
The main outcomes include pain reduction (measured by pain scales such as WOMAC and VAS), improvement in joint function, and structural changes in the knee assessed by MRI. In addition, laboratory tests will be used to measure inflammation, cartilage health markers, and oxidative stress before and after treatment.
The goal is to determine whether HILT provides better pain relief, improves joint function, and is safe compared to standard therapy. The results may help improve rehabilitation strategies for patients with knee osteoarthritis.
Detailed description
Knee Osteoarthritis is a chronic degenerative joint disorder characterized by progressive cartilage loss, pain, stiffness, and functional limitation. It is a leading cause of disability, particularly among older adults, and its prevalence is increasing with population aging.
Non-surgical management is the first-line approach and includes exercise therapy and physical modalities aimed at reducing pain and improving joint function. High-Intensity Laser Therapy is a non-invasive modality that delivers high-energy light to tissues, promoting cellular activity, increasing adenosine triphosphate (ATP) production, enhancing microcirculation, and reducing inflammation and edema. In contrast, Low-Level Laser Therapy has been more extensively studied, while evidence regarding HILT remains limited.
This study is a randomized comparative trial designed to evaluate the efficacy and safety of HILT compared with conventional physical therapy modalities in patients with knee osteoarthritis. A total of 100 participants meeting the American College of Rheumatology criteria will be recruited from rheumatology and rehabilitation centers in Erbil, Iraq. Participants will be randomly assigned to one of two groups: (1) HILT combined with therapeutic exercise, or (2) conventional physical therapy modalities combined with therapeutic exercise.
The primary outcome is pain intensity at 4 weeks, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale or Visual Analogue Scale (VAS). Secondary outcomes include pain at 8 weeks and functional status. Structural joint changes will be evaluated using magnetic resonance imaging (MRI), including assessment of cartilage thickness, joint irregularity, effusion, and osteophyte formation.
Laboratory assessments will be conducted before and after intervention to evaluate biological effects. These include inflammatory markers (C-reactive protein), gene expression markers related to cartilage metabolism (TGFB1, FOXO1, COMP, and MMP3) measured by RT-PCR, and oxidative stress markers (malondialdehyde [MDA] and superoxide dismutase [SOD]) measured using ELISA.
Eligible participants are adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis who are able to provide informed consent and comply with study procedures. Exclusion criteria include contraindications to laser therapy (e.g., malignancy, epilepsy, photosensitivity, or local infection), recent knee surgery, advanced osteoarthritis requiring surgical intervention, pregnancy or lactation, and severe comorbid conditions that may affect participation or outcomes.
Data will be analyzed using Statistical Package for the Social Sciences (SPSS, version 21). Ethical approval will be obtained from the relevant institutional review bodies, and written informed consent will be obtained from all participants. Confidentiality will be maintained throughout the study.
This study aims to determine whether HILT provides superior clinical and biological outcomes compared with conventional physical therapy modalities in the management of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group, open-label comparative study. Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups using simple randomization. Group 1 will receive High-Intensity Laser Therapy (HILT) plus therapeutic exercise, and Group 2 will receive classical physical modalities (ultrasound/TENS) plus therapeutic exercise. The study is unblinded (open-label) as the nature of the interventions makes blinding of participants and therapists impractical. However, outcome assessors for MRI evaluation will be blinded to group allocation. Treatment duration is 8 weeks with follow-up assessments at baseline, 4 weeks, and 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (HILT) | Experimental | Device: High-Intensity Laser Therapy (HILT), Device: Conventional Physical Therapy ModalitiesPatients will receive High-Intensity Laser Therapy (HILT) combined with a standardized therapeutic exercise program. HILT parameters include four-wavelength beam, continuous/modulating frequencies, and SuperPulse mode for deep penetration. |
| Classical Modalities | Active comparator | Device: High-Intensity Laser Therapy (HILT), Device: Conventional Physical Therapy ModalitiesPatients will receive classical physical modalities (such as therapeutic ultrasound or TENS, as per standard local practice) combined with the same standardized therapeutic exercise program. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Knee Osteoarthritis: Patients must have a clinical and radiographic diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria, including evidence of joint space narrowing, osteophyte formation, and other degenerative changes observed on X-rays or MRI.
- Age: Adults aged between 40 and 75 years. Willingness to Participate: Participants must provide informed consent and be willing to adhere to the study protocol, including attending all treatment sessions and follow-up assessments.
- Kellgren-Lawrence Grade: Patients with knee OA grades 1-3 (mild to moderate OA).
Key exclusion criteria (10 listed)
- Contraindications to Laser Therapy:
- Active malignancy History of epilepsy Photosensitivity disorders Active infection in the treatment area
- Patients who have undergone knee surgery within the past 6 months Scheduled surgery during the study period
- Kellgren-Lawrence Grade 4 (severe OA) where surgical intervention is indicated
- Pregnant or lactating women
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 |
|---|---|---|
| High-Intensity Laser Therapy (HILT)Also: High Power Laser Therapy, Class IV Laser TherapyHigh-Intensity Laser Therapy (HILT) combined with therapeutic exercise program. HILT Specifications: * Four-wavelength beam system for deep tissue penetration * Continuous and modulating frequencies to promote pain control and healing * SuperPulse mode for deeper therapeutic penetration * High power output delivering larger doses with shorter treatment times * Pre-programmed presets for consistent and safe treatment outcomes Mechanism of Action: HILT delivers high energy output into tissues, generating photochemical effects including: * Increased mitochondrial oxidation and ATP production * Enhanced blood circulation and metabolism * Fast absorption of edema and removal of exudates * Increased serotonin and endorphin levels * Anti-inflammatory effects through reduced prostaglandin synthesis * Decreased nerve cell membrane permeability for Na/K causing hyperpolarization * Increased lymphatic flow * Modulation of genetic markers: increased expression of cartilage protection biomarkers | Device | Classical Modalities, Experimental Group (HILT) |
| Conventional Physical Therapy ModalitiesAlso: Therapeutic Ultrasound, Microwave diathermy, Transcutaneous Electrical Nerve Stimulation (TENS), Deep heat TherapyClassical Physical Modalities combined with therapeutic exercise program. Modalities Include: * Therapeutic Ultrasound and/or other conventional physical therapy modalities as per standard clinical practice for knee osteoarthritis * Evidence-based parameters for knee OA treatment Treatment Protocol: * Duration: 8 weeks * Combined with the same standardized therapeutic exercise program as the HILT group * Sessions will be conducted at rheumatology and rehabilitation units in Erbil, Iraq This represents the current standard of care for conservative management of knee osteoarthritis in physical medicine and rehabilitation settings. | Device | Classical Modalities, Experimental Group (HILT) |
Primary outcome
Change in Pain Intensity (WOMAC Pain Subscale)
Time frame: Baseline to 4 weeks post-treatment initiation
Pain intensity will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The WOMAC is a validated instrument that measures pain, stiffness, and physical function in patients with osteoarthritis. The pain subscale consists of 5 items scored on a 0-10 scale, with higher scores indicating more severe pain.
1 secondary outcome
Change in Pain Intensity (Visual Analog Scale - VAS)
Time frame: Baseline to 4 weeks post-treatment initiation
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 Apr 2026.
- Results publication: PubMed 24926119Igawa T, Katsuhira J. Biomechanical analysis of stair descent in patients with knee osteoarthritis. J Phys Ther Sci. 2014 May;26(5):629-31. doi: 10.1589/jpts.26.629. Epub 2014 May 29.
- Results publication: PubMed 12443949Manetta J, Franz LH, Moon C, Perell KL, Fang M. Comparison of hip and knee muscle moments in subjects with and without knee pain. Gait Posture. 2002 Dec;16(3):249-54. doi: 10.1016/s0966-6362(02)00009-7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) protection of participant privacy and confidentiality in accordance with Iraqi health research regulations and institutional ethical guidelines; (2) the need to protect data integrity for ongoing PhD thesis completion and future publications; (3) local institutional policies regarding data sharing. De-identified summary data may be available from the principal investigator upon reasonable request and with appropriate data use agreements after completion of the PhD program and primary publications.
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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.
Ahmed Bapir, PhD study director
EPU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy (HILT) and Conventional Physical Therapy Modalities in people with Knee Arthritis Osteoarthritis, run by Erbil Polytechnic University at 1 site in Iraq.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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 Iraq. 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?
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 Mahdi Qadir, PhD (+9647504631542, mahdiqader@epu.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (WOMAC Pain Subscale) (time frame: Baseline to 4 weeks post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551245, which also lists 2 linked publications.
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 Apr 2026.