Osteoarthritis (OA) of the KneeHILT-KOANCT07584603
Effect of High-Intensity Laser Therapy on Femoral Cartilage in Knee Osteoarthritis
A study testing High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy and Conventional Physiotherapy in people with Osteoarthritis (OA) of the Knee and Osteoarthitis, run by University of Lahore at 1 site in Pakistan.
Trial summary
This clinical trial will evaluate the effects of High-Intensity Laser Therapy (HILT) on femoral cartilage thickness and other clinical outcomes in people with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Osteoarthitis
- What is being tested?
- High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy and Conventional Physiotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 10 May 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants aged 40-60 years.
- Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade II or III).
- Knee pain for at least 3 months.
- Visual Analogue Scale (VAS) score ≥ 3.
- Willing to provide written informed consent and comply with treatment and follow-up schedule.
Who cannot join
- History of knee surgery or traumatic knee injury.
- Inflammatory arthritis (e.g., gout, psoriatic arthritis).
- History of cancer or psychiatric illness.
- Cognitive disorders (e.g., Parkinson's disease, Alzheimer's disease).
- Severe comorbidities limiting exercise (e.g., severe COPD, heart failure, cerebrovascular event).
- Hip or ankle joint disability.
- Intra-articular knee injection within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
London Aesthetics and Rejuvenation Center
Lahore, Punjab Province, 55000
Ayesha Malik, MS, 03047779396, ayeshabutt031@gmail.com
Ishaq Ahmed, Ph.D. Physical Therapy, 03344066463, ishaq.ahmed@uipt.uol.edu.pk
About this study
Official title: The Role of High-intensity Laser Therapy on Femoral Cartilage Thickness in Patients With Knee Osteoarthritis
This clinical trial will evaluate the effects of High-Intensity Laser Therapy (HILT) on femoral cartilage thickness and other clinical outcomes in people with knee osteoarthritis. Participants aged 40 to 60 years with grade II or III knee osteoarthritis will be randomly assigned to receive either HILT plus conventional physiotherapy or conventional physiotherapy alone. Both groups will receive 12 treatment sessions on alternate days for 4 weeks. The study will assess changes in cartilage thickness using ultrasound, as well as improvements in pain, knee movement, muscle strength, and daily function. Findings from this research may help improve physiotherapy treatment strategies for patients with knee osteoarthritis.
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthitis
- Being tested
- High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy, Conventional Physiotherapy
- Keywords
- High Intensity Laser Therapy, Knee Osteoarthritis, Femoral Cartilage Thickness, High Level Laser Therapy, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT) + Conventional PhysiotherapyDevice
HILT will be administered using a Class IV laser applied perpendicularly at eight standardized knee points. Both analgesic and biostimulation modes will be used.. Sessions will be conducted on alternate days for 4 weeks (12 sessions total).
Conventional PhysiotherapyOther
Conventional physiotherapy includes hot moist pack application, manual joint mobilization, stretching, and strengthening exercises for quadriceps and hamstrings. Sessions will be held on alternate days for 4 weeks (12 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy | Experimental | Participants in this group will receive High-Intensity Laser Therapy (HILT) using a Class IV laser (1064 nm wavelength) applied at eight standardized knee points according to WALT guidelines, along with conventional physiotherapy including hot moist pack, joint mobilization, and strengthening exercises. Treatment will be given on alternate days for 4 weeks (12 sessions total). Receives: Device: High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy |
| Conventional Physiotherapy | Active comparator | Participants in this group will receive only conventional physiotherapy, including hot moist pack, patellofemoral and tibiofemoral joint mobilization, and a structured exercise program for quadriceps and hamstrings. Treatment will be given on alternate days for 4 weeks (12 sessions total). Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral Cartilage Thickness
Mean change in femoral cartilage thickness (mm) measured by high-frequency musculoskeletal ultrasound at three standardized sites - medial femoral condyle, intercondylar notch, and lateral femoral condyle. The measurement will be performed using a 7-12 MHz linear probe following standardized scanning protocol
Measured: Baseline, Week 4
Secondary outcomes (5)
Pain Intensity
Change in pain intensity will be measured using the Visual Analogue Scale (VAS), a 10-centimeter horizontal scale ranging from 0 to 10, where 0 will represent 'no pain' and 10 will represent the 'worst imaginable pain.' Higher scores will indicate worse pain.
Measured: Baseline, Week 2, Week 4
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index measures pain and functional disability and contains 24 questions: 5 for pain, 2 for joint stiffness, and 17 for physical function. Each item is scored qualitatively as none, low, moderate, severe, or very severe, with equivalent numerical scores of 0, 1, 2, 3, and 4. Higher scores indicate a greater negative effect on quality of life
Measured: Baseline, Week 2, Week 4
Knee Range of Motion (ROM)
Active knee flexion and extension measured using a universal goniometer. Flexion is normally up to approximately 135 degrees. Higher degrees of motion indicate better knee mobility.
Measured: Baseline, Week 2, Week 4
One-Leg Stance Test
The participant will stand on one leg with hands on hips and the opposite knee flexed to approximately 90°, and the time maintained in this position will be recorded in seconds. Maintaining the stance for at least 10 seconds will be considered the minimum threshold for functional balance. A longer time will indicate better balance performance.
Measured: Baseline, Week 2, Week 4
Quadriceps Muscle Strength
Change in quadriceps strength will be measured using Manual Muscle Testing (Oxford/MRC scale). Muscle strength will be graded on a scale from 0 to 5, where 0 represents no muscle contraction and 5 represents normal strength against full resistance. Higher scores will indicate better quadriceps strength
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Participants will be randomly assigned into two parallel groups: one receiving High-Intensity Laser Therapy (HILT) plus conventional physiotherapy, and the other receiving conventional physiotherapy alone. Each group will receive 12 treatment sessions on alternate days for 4 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584603
- Sponsor's protocol ID
- UOL/IREB/25/12/0033
- Acronym
- HILT-KOA
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of High-intensity Laser Therapy on Femoral Cartilage Thickness in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07584603
- Acronym / sponsor ID
- HILT-KOA / UOL/IREB/25/12/0033
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthitis
- Keywords
- High Intensity Laser Therapy, Knee Osteoarthritis, Femoral Cartilage Thickness, High Level Laser Therapy, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 13 May 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 clinical trial will evaluate the effects of High-Intensity Laser Therapy (HILT) on femoral cartilage thickness and other clinical outcomes in people with knee osteoarthritis. Participants aged 40 to 60 years with grade II or III knee osteoarthritis will be randomly assigned to receive either HILT plus conventional physiotherapy or conventional physiotherapy alone. Both groups will receive 12 treatment sessions on alternate days for 4 weeks. The study will assess changes in cartilage thickness using ultrasound, as well as improvements in pain, knee movement, muscle strength, and daily function. Findings from this research may help improve physiotherapy treatment strategies for patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: one receiving High-Intensity Laser Therapy (HILT) plus conventional physiotherapy, and the other receiving conventional physiotherapy alone. Each group will receive 12 treatment sessions on alternate days for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy | Experimental | Device: High-Intensity Laser Therapy (HILT) + Conventional PhysiotherapyParticipants in this group will receive High-Intensity Laser Therapy (HILT) using a Class IV laser (1064 nm wavelength) applied at eight standardized knee points according to WALT guidelines, along with conventional physiotherapy including hot moist pack, joint mobilization, and strengthening exercises. Treatment will be given on alternate days for 4 weeks (12 sessions total). |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants in this group will receive only conventional physiotherapy, including hot moist pack, patellofemoral and tibiofemoral joint mobilization, and a structured exercise program for quadriceps and hamstrings. Treatment will be given on alternate days for 4 weeks (12 sessions total). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants aged 40-60 years.
- Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade II or III).
- Knee pain for at least 3 months.
- Visual Analogue Scale (VAS) score ≥ 3.
- Willing to provide written informed consent and comply with treatment and follow-up schedule.
Key exclusion criteria (7 listed)
- History of knee surgery or traumatic knee injury.
- Inflammatory arthritis (e.g., gout, psoriatic arthritis).
- History of cancer or psychiatric illness.
- Cognitive disorders (e.g., Parkinson's disease, Alzheimer's disease).
- Severe comorbidities limiting exercise (e.g., severe COPD, heart failure, cerebrovascular event).
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) + Conventional PhysiotherapyHILT will be administered using a Class IV laser applied perpendicularly at eight standardized knee points. Both analgesic and biostimulation modes will be used.. Sessions will be conducted on alternate days for 4 weeks (12 sessions total). | Device | High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy |
| Conventional PhysiotherapyConventional physiotherapy includes hot moist pack application, manual joint mobilization, stretching, and strengthening exercises for quadriceps and hamstrings. Sessions will be held on alternate days for 4 weeks (12 sessions total). | Other | Conventional Physiotherapy |
Primary outcome
Femoral Cartilage Thickness
Time frame: Baseline, Week 4
Mean change in femoral cartilage thickness (mm) measured by high-frequency musculoskeletal ultrasound at three standardized sites - medial femoral condyle, intercondylar notch, and lateral femoral condyle. The measurement will be performed using a 7-12 MHz linear probe following standardized scanning protocol
5 secondary outcomes
Pain Intensity
Time frame: Baseline, Week 2, Week 4
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Baseline, Week 2, Week 4
Knee Range of Motion (ROM)
Time frame: Baseline, Week 2, Week 4
One-Leg Stance Test
Time frame: Baseline, Week 2, Week 4
Quadriceps Muscle Strength
Time frame: Baseline, Week 2, 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 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis (OA) of the 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
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
RecruitingPhase 3
A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
Obesity, Overweight and/or Obesity
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
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.
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) + Conventional Physiotherapy and Conventional Physiotherapy in people with Osteoarthritis (OA) of the Knee and Osteoarthitis, run by University of Lahore at 1 site in Pakistan.
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 7 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 13 May 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 Pakistan. 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 Iqra Waseem, Ph.D Scholar (+923347779399, iqra.waseem91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Cartilage Thickness (time frame: Baseline, Week 4). 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 13 May 2026.