Primary Knee OsteoarthritisNCT06825767
Comparison of the Effectiveness of High-Intensity and Low-Intensity Laser Therapies in Primary Knee Osteoarthritis
A study testing Conventional Treatment, conventional treatment and high-intensity laser therapy(HILT) and conventional treatment and low-intensity laser therapy (LLLT) in people with Primary Knee Osteoarthritis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Primary Knee Osteoarthritis
- What is being tested?
- Conventional Treatment, conventional treatment and high-intensity laser therapy(HILT) and conventional treatment and low-intensity laser therapy (LLLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 55-75 years
- Primary knee OA diagnosis according to ACR (American College of Rheumatology) and Knee OA classified as stage 2-3 according to the KL (Kellgren-Lawrence) radiological classification
- Visual pain score of 4 or higher for knee pain lasting for at least 3 months
Who cannot join
- Patients with secondary knee OA
- Patients who have undergone surgical operations related to the knee joint
- Patients with pathology in the hip and/or ankle on the same side
- Patients who have received intra-articular corticosteroid, hyaluronic acid, or PRP injections in the knee joint in the last 6 months
- Patients who have received physical therapy for the knee region in the last 6 months
- Patients with serious systemic diseases such as malignancy, congestive heart failure, or chronic obstructive pulmonary disease
- Patients with insufficient cognitive function
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Phisical Therapy and Rehabilitation Hospital
Ankara, Bilkent-Cankaya, 06800
About this study
Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.
Read the detailed description
In the study, those who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital outpatient clinic between 01.10.2020-01.10.2021, were between the ages of 55-75, were diagnosed with primary knee OA according to the American Rheumatology Association, stage 2-3 knee according to Kellgren and Lawrence radiological classification. with OA; 72 volunteer patients with knee pain with a visual pain score of 4 and above for at least 3 months were included. The study was designed as a prospective, randomized, controlled, single-center. Patients were randomly divided into 3 treatment groups. Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients in the first group, conventional treatment and HILT were applied to 24 patients in the second group, and conventional treatment and LLLT were applied to 24 patients in the third group. All groups were evaluated clinically and ultrasonographically at the beginning of the treatment, at the end of the treatment and at the 3rd month after the treatment.
- Conditions
- Primary Knee Osteoarthritis
- Being tested
- Conventional Treatment, conventional treatment and high-intensity laser therapy(HILT), conventional treatment and low-intensity laser therapy (LLLT)
- Keywords
- Osteoarthritis, Low level light therapy, high level light therapy,Muscle Skeletal; Ultrasonography
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TreatmentDevice
Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients
conventional treatment and high-intensity laser therapy(HILT)Device
Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients .
conventional treatment and low-intensity laser therapy (LLLT)Device
Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Active comparator | Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients. Receives: Device: Conventional Treatment |
| conventional treatment and HILT(high-intensity laser therapy) | Active comparator | Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients . Receives: Device: conventional treatment and high-intensity laser therapy(HILT) |
| conventional treatment and LLLT(low-intensity laser therapy) | Active comparator | Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients. Receives: Device: conventional treatment and low-intensity laser therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
In the clinical evaluation, the range of motion of the patients in the affected extremity was determined by goniometry
Measured: Baseline, after 1 month and 3 month changes
visual pain score (VAS)
In the clinical evaluation, the pain score with movement and resting was determined by visual pain score (VAS).The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Measured: Baseline, after 1 month and 3 month changes
Secondary outcomes (4)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities (WOMAC) index is the most common used clinical tools for evaluating patients with knee OA.It is consisted of 33 items which evaluates the health and function of the patient from various aspects including: clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions).
Each question has five subscales where best situation scores as never or none and the worst one names as extreme or always. Here, higher scores are representative of better situation and less pain.
Measured: Baseline, after 1 month and 3 month changes
Lequesne Index
The Lequesne index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living . The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability
Measured: Baseline, after 1 month and 3 month changes
Short form SF-36 scale
The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.
Measured: Baseline, after 1 month and 3 month changes
Femoral cartilage thickness
The femoral cartilage thickness measurements of the patients participating in the study were performed using a Logiq 9 (GE Medical Systems®) ultrasound device with a linear probe (7-12 MHz, "ZONARE"). The ultrasonographic measurement was performed in the supine position of the patient, with the knee in maximum flexion, at three different locations: the medial femoral intercondylar region, the median intercondylar region, and the lateral femoral intercondylar region. The probe was placed transversely on the thigh, perpendicular to the bone surface, immediately above the superior corner of the patella. The cartilage thickness was calculated by measuring the hypoechoic distance between the two hyperechoic lines: one showing the soft tissue-cartilage surface and the other showing the cartilage-bone surface. Three measurements were taken for each knee, and the average was calculated.
Measured: Baseline, after 1 month and 3 month changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Oct 2020
- Primary completion1 Jun 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida Koçer Nazlıgül, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825767
- Sponsor's protocol ID
- E1-20-1087
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of High-Intensity and Low-Intensity Laser Therapies in Primary Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06825767
- Acronym / sponsor ID
- E1-20-1087
- Conditions
- Primary Knee Osteoarthritis
- Keywords
- Osteoarthritis, Low level light therapy, high level light therapy,Muscle Skeletal; Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 13 Feb 2025 (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.
Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.
Detailed description
In the study, those who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital outpatient clinic between 01.10.2020-01.10.2021, were between the ages of 55-75, were diagnosed with primary knee OA according to the American Rheumatology Association, stage 2-3 knee according to Kellgren and Lawrence radiological classification. with OA; 72 volunteer patients with knee pain with a visual pain score of 4 and above for at least 3 months were included. The study was designed as a prospective, randomized, controlled, single-center. Patients were randomly divided into 3 treatment groups. Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients in the first group, conventional treatment and HILT were applied to 24 patients in the second group, and conventional treatment and LLLT were applied to 24 patients in the third group. All groups were evaluated clinically and ultrasonographically at the beginning of the treatment, at the end of the treatment and at the 3rd month after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Device: Conventional TreatmentConventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients. |
| conventional treatment and HILT(high-intensity laser therapy) | Active comparator | Device: conventional treatment and high-intensity laser therapy(HILT)Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients . |
| conventional treatment and LLLT(low-intensity laser therapy) | Active comparator | Device: conventional treatment and low-intensity laser therapy (LLLT)Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range of 55-75 years
- Primary knee OA diagnosis according to ACR (American College of Rheumatology) and Knee OA classified as stage 2-3 according to the KL (Kellgren-Lawrence) radiological classification
- Visual pain score of 4 or higher for knee pain lasting for at least 3 months
Key exclusion criteria (7 listed)
- Patients with secondary knee OA
- Patients who have undergone surgical operations related to the knee joint
- Patients with pathology in the hip and/or ankle on the same side
- Patients who have received intra-articular corticosteroid, hyaluronic acid, or PRP injections in the knee joint in the last 6 months
- Patients who have received physical therapy for the knee region in the last 6 months
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 |
|---|---|---|
| Conventional TreatmentConventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients | Device | conventional treatment |
| conventional treatment and high-intensity laser therapy(HILT)Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients . | Device | conventional treatment and HILT(high-intensity laser therapy) |
| conventional treatment and low-intensity laser therapy (LLLT)Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients. | Device | conventional treatment and LLLT(low-intensity laser therapy) |
Primary outcome
range of motion
Time frame: Baseline, after 1 month and 3 month changes
In the clinical evaluation, the range of motion of the patients in the affected extremity was determined by goniometry
visual pain score (VAS)
Time frame: Baseline, after 1 month and 3 month changes
In the clinical evaluation, the pain score with movement and resting was determined by visual pain score (VAS).The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
4 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, after 1 month and 3 month changes
Lequesne Index
Time frame: Baseline, after 1 month and 3 month changes
Short form SF-36 scale
Time frame: Baseline, after 1 month and 3 month changes
Femoral cartilage thickness
Time frame: Baseline, after 1 month and 3 month changes
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 13 Feb 2025.
- Individual participant dataSharing planned: No
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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. 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 Conventional Treatment, conventional treatment and high-intensity laser therapy(HILT) and conventional treatment and low-intensity laser therapy (LLLT) in people with Primary Knee Osteoarthritis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 13 Feb 2025. 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 Turkey (Türkiye). 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?
range of motion (time frame: Baseline, after 1 month and 3 month changes). The study lists 2 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 13 Feb 2025.