Knee OsteoarthritisOANCT06419569
Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis
A study testing high power laser, low level laser and conventional physical therapy in people with Knee Osteoarthritis, run by Cairo University.
Trial summary
this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- high power laser, low level laser and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 15 Dec 2024
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- X-ray stages II and III osteoarthritis
- Age between 45 and 75 years.
- BMI equal to or less than 35.
Who cannot join
- Unwillingness to participate in the study.
- Uncompleted evaluation/treatment programs.
- Any damage to the knee joint during the study.
- Using any treatment other than prescribed therapeutic protocols.
Trial locations and contacts
No sites are listed yet.
About this study
this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis
Read the detailed description
Osteoarthritis (OA) is a major source of pain, disability, and socioeconomic cost worldwide. The epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. It is estimated that 63 to 85 percent of Americans over age 65 have radiographic signs of OA and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. Between 9 and 12 percent of elderly Americans (approximately 3 million people) have enough impairment from OA that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). High power laser therapy (HPL) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. One of the modalities commonly used by clinicians was Low Level Laser Therapy introduced as an alternative, safe and non-invasive treatment for OA about 30 years ago.A more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that Both LLLT and HPL are beneficial as adjuncts to rehabilitation exercise in the management of knee OA. Based on an indirect comparison, the HPL and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. To confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only
- Conditions
- Knee Osteoarthritis
- Being tested
- high power laser, low level laser, conventional physical therapy
- Keywords
- High Power Laser, Low Level Laser, Ultrasonographic changes, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high power laserOther
Sessions will performed with scanning in longitudinal and perpendicular direction on the medial and lateral sides of the knee with Laser scanner machine. handpiece was positioned in contact and perpendicularly while the patient in a supine lying position with the knee flexed at 30° to open the joint surfaces to the laser beam (optical windows). The scanning was performed transversely and longitudinally in the anterior, medial, and lateral aspects of the knee joint with emphasis on the application on the joint line between the tibial and femoral epicondyles. The total energy delivered to the patient during one session was 1,250 J through three phases of treatment. The initial phase is performed with fast manual scanning with a total of 500 J. In the initial phase, the laser fluency is set to two successive subphases of 710 and 810 mJ/cm2 for a total of 500 J.
low level laserOther
patients will receive laser with 0.5 W to gain energy density of 6 J/cm2, and total energy of 240 J during one session. LASER apparatus that will be used is Chattanoga Intelect Laser with 850nm wavelength and 200mW power Lasers. Same three phases like HPL with different energy dose. First phase: Fast manual scan 100 J. Second 10 point joint line phase with evey point 14 seconds and 4J to deliver a total of 40 J in this phase. Third phase: Slow manual scan 100 J.
conventional physical therapyOther
the patients will receive conventiobal physical therapy in the form of Exercise therapy program (1) Warm-up exercises: Walking at the usual speed on a flat surface for 10 min with hamstring and calf gentle stretches.(2) Major exercises for knee OA: Straight leg raise, quadriceps setting, heel raise, one leg balance, step ups, and quadriceps strengthening exercises. The US protocol consists of continuous ultrasonic waves of 1 MHz frequency and 1 W/cm2 intensity applied with a 5-cm diameter applicator. The patients will be placed in a supine position, and the US applied to the medial and lateral parts (5 min on each side) of the knee in circular movements with the probe at right angles to ensure maximum absorption of the energy.
| Study group | Role | What they receive |
|---|---|---|
| high power laser | Experimental | thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks Receives: Other: high power laser; Other: conventional physical therapy |
| low level laser | Experimental | thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks Receives: Other: low level laser; Other: conventional physical therapy |
| conventional physical therapy | Active comparator | thirty patients will receive conventional physical therapy three times a week for eight weeks Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteophyte diameter
ultrasonographe device will be used to assess the osteophyte diameter
Measured: up to eight weeks
hyaline cartilage thickness assessment
utrasonographe device will be used to assess hyaline cartilage thickness
Measured: up to eight weeks
Secondary outcomes (4)
knee function
Knee Injury and Osteoarthritis Outcome Score questionnaire will be used to assess knee function.five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: up to eight weeks
pain intensity
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: up to eight weeks
knee range of motion
digital goniometer will be used to assess knee range of motion
Measured: up to eight weeks
pressure pain threshold
algometer will be used to assess pressure pain threshold
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 May 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
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
- high power laser and low level laser
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419569
- Sponsor's protocol ID
- P.T.REC/012/003450
- Acronym
- OA
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06419569
- Acronym / sponsor ID
- OA / P.T.REC/012/003450
- Conditions
- Knee Osteoarthritis
- Keywords
- High Power Laser, Low Level Laser, Ultrasonographic changes, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 17 May 2024 (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 will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis
Detailed description
Osteoarthritis (OA) is a major source of pain, disability, and socioeconomic cost worldwide. The epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. It is estimated that 63 to 85 percent of Americans over age 65 have radiographic signs of OA and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. Between 9 and 12 percent of elderly Americans (approximately 3 million people) have enough impairment from OA that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). High power laser therapy (HPL) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. One of the modalities commonly used by clinicians was Low Level Laser Therapy introduced as an alternative, safe and non-invasive treatment for OA about 30 years ago.A more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that Both LLLT and HPL are beneficial as adjuncts to rehabilitation exercise in the management of knee OA. Based on an indirect comparison, the HPL and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. To confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- high power laser and low level laser
| Arm | Type | Receives |
|---|---|---|
| high power laser | Experimental | Other: high power laser, Other: conventional physical therapythirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks |
| low level laser | Experimental | Other: low level laser, Other: conventional physical therapythirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks |
| conventional physical therapy | Active comparator | Other: conventional physical therapythirty patients will receive conventional physical therapy three times a week for eight weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- X-ray stages II and III osteoarthritis
- Age between 45 and 75 years.
- BMI equal to or less than 35.
Key exclusion criteria (4 listed)
- Unwillingness to participate in the study.
- Uncompleted evaluation/treatment programs.
- Any damage to the knee joint during the study.
- Using any treatment other than prescribed therapeutic protocols.
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 power laserSessions will performed with scanning in longitudinal and perpendicular direction on the medial and lateral sides of the knee with Laser scanner machine. handpiece was positioned in contact and perpendicularly while the patient in a supine lying position with the knee flexed at 30° to open the joint surfaces to the laser beam (optical windows). The scanning was performed transversely and longitudinally in the anterior, medial, and lateral aspects of the knee joint with emphasis on the application on the joint line between the tibial and femoral epicondyles. The total energy delivered to the patient during one session was 1,250 J through three phases of treatment. The initial phase is performed with fast manual scanning with a total of 500 J. In the initial phase, the laser fluency is set to two successive subphases of 710 and 810 mJ/cm2 for a total of 500 J. | Other | high power laser |
| low level laserpatients will receive laser with 0.5 W to gain energy density of 6 J/cm2, and total energy of 240 J during one session. LASER apparatus that will be used is Chattanoga Intelect Laser with 850nm wavelength and 200mW power Lasers. Same three phases like HPL with different energy dose. First phase: Fast manual scan 100 J. Second 10 point joint line phase with evey point 14 seconds and 4J to deliver a total of 40 J in this phase. Third phase: Slow manual scan 100 J. | Other | low level laser |
| conventional physical therapythe patients will receive conventiobal physical therapy in the form of Exercise therapy program (1) Warm-up exercises: Walking at the usual speed on a flat surface for 10 min with hamstring and calf gentle stretches.(2) Major exercises for knee OA: Straight leg raise, quadriceps setting, heel raise, one leg balance, step ups, and quadriceps strengthening exercises. The US protocol consists of continuous ultrasonic waves of 1 MHz frequency and 1 W/cm2 intensity applied with a 5-cm diameter applicator. The patients will be placed in a supine position, and the US applied to the medial and lateral parts (5 min on each side) of the knee in circular movements with the probe at right angles to ensure maximum absorption of the energy. | Other | conventional physical therapy, high power laser, low level laser |
Primary outcome
osteophyte diameter
Time frame: up to eight weeks
ultrasonographe device will be used to assess the osteophyte diameter
hyaline cartilage thickness assessment
Time frame: up to eight weeks
utrasonographe device will be used to assess hyaline cartilage thickness
4 secondary outcomes
knee function
Time frame: up to eight weeks
pain intensity
Time frame: up to eight weeks
knee range of motion
Time frame: up to eight weeks
pressure pain threshold
Time frame: up to eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing high power laser, low level laser and conventional physical therapy in people with Knee Osteoarthritis, run by Cairo 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed H abdo, doctoral (01007433819, theorymtc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
osteophyte diameter (time frame: up to eight weeks). 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 17 May 2024.