Knee OsteoarthritisNCT05510648
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
A study testing high-intensity laser therapy in people with Knee Osteoarthritis and Laser Therapy, run by Necmettin Erbakan University.
Trial summary
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Laser Therapy, Muscle Strength
- What is being tested?
- high-intensity laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2022to 25 Nov 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
Who cannot join
- History of surgery or traumatic injury
- Inflammatory arthritis
- History of cancer, bleeding diathesis and psychiatric disease
- Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
- Hip and ankle problems
- Participating in another physical therapy program in the last 3 months
- History of intra-articular injections in the last 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of High-intensity Laser Therapy in Knee Osteoarthritis
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.
Read the detailed description
Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.
- Conditions
- Knee Osteoarthritis, Laser Therapy, Muscle Strength
- Being tested
- high-intensity laser therapy, sham high-intensity laser therapy
- 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-intensity laser therapyOther
A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.
sham high-intensity laser therapyOther
Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy | Active comparator | A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The hotpack, which is used as a superficial heater, is applied to the knee area for 30 minutes, wrapped in two layers of towels. As analgesic current, conventional TENS is applied to the knee area for 30 minutes with 4 electrodes at 80 Hz frequency, 200 ms current duration. Flow intensity is adjusted according to the patient's tolerance, and the current intensity is increased as the patient's sense of current decreased in the following periods. HILT is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks. Receives: Other: high-intensity laser therapy; Other: sham high-intensity laser therapy |
| Sham high-intensity laser therapy | Sham comparator | Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions. Receives: Other: high-intensity laser therapy; Other: sham high-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Measured: Baseline and month 3
Secondary outcomes (5)
Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3
The range of motion of the patients, consisting of knee flexion and extension, is actively evaluated with a goniometer. In the measurement of the flexion angle, the patient is lying in the prone position and the extension angle is measured as the limitation of extension when the knee joint is at 0 degrees
Measured: Baseline and month 3
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
Femoral cartilage thickness is measured by the same physician by placing the probe axially in the suprapatellar region by ultrasonography while the patient is lying on his back and the knees are in maximum flexion. The distance between the thin hyperechoic line at the synovial cartilage interface and the sharp hyperechoic line at the cartilage-bone interface is defined as cartilage thickness
Measured: Baseline and month 3
SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3
The SF-36 scale measures 8 dimensions of health and consists of 36 items; physical function (10 items), social function (2 items), role related to physical functions limitations (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/fatigue (4 items), pain (2 items), and general perception of health (5 items). It is evaluated between 0 and 100 points; 0 represents poor health, 100 represents good health. There are two summary components, the physical component and the mental component
Measured: Baseline and month 3
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3
It is widely used in studies with knee OA patients. The scale, each question of which is evaluated with a 5-point Likert scale, consists of 24 questions. It is filled by patients. There are pain, physical function and stiffness subscales. Pain subscale is evaluated with five items and is scored between 0-20. The hardness subscale has two items and is scored between 0-8. Function subscale consists of 17 items and is scored between 0-68. A high score indicates poor function, pain or stiffness.
Measured: Baseline and month 3
Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3
Knee isokinetic muscle strength is measured with the Biodex System-3 isokinetic device . At 60° and 180° angular velocities, the range of motion was 90° flexion 0° extension, after three repetitions at each angular velocity; Measurements are made in a single set-five repetitions with 10 seconds of rest between repetitions
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start25 Sep 2022 (estimated)
- Primary completion25 Sep 2022 (estimated)
- Study completion25 Nov 2022 (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 Necmettin Erbakan 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
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Ordahan, Necmettin Erbakan University
- Investigators
- BANU ORDAHAN, Principal investigator, Meram Medical School, Necmettin Erbakan University, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510648
- Sponsor's protocol ID
- BANU ORDAHAN
- Status last verified
- Sep 2022
- First submitted
- 18 Aug 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-intensity Laser Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05510648
- Acronym / sponsor ID
- BANU ORDAHAN
- Conditions
- Knee Osteoarthritis, Laser Therapy, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 22 Aug 2022 (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.
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.
Detailed description
Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy | Active comparator | Other: high-intensity laser therapy, Other: sham high-intensity laser therapyA total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The hotpack, which is used as a superficial heater, is applied to the knee area for 30 minutes, wrapped in two layers of towels. As analgesic current, conventional TENS is applied to the knee area for 30 minutes with 4 electrodes at 80 Hz frequency, 200 ms current duration. Flow intensity is adjusted according to the patient's tolerance, and the current intensity is increased as the patient's sense of current decreased in the following periods. HILT is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks. |
| Sham high-intensity laser therapy | Sham comparator | Other: high-intensity laser therapy, Other: sham high-intensity laser therapyHotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
Key exclusion criteria (7 listed)
- History of surgery or traumatic injury
- Inflammatory arthritis
- History of cancer, bleeding diathesis and psychiatric disease
- Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
- Hip and ankle problems
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 therapyA total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks. | Other | High-intensity laser therapy, Sham high-intensity laser therapy |
| sham high-intensity laser therapyHotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions. | Other | High-intensity laser therapy, Sham high-intensity laser therapy |
Primary outcome
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Time frame: Baseline and month 3
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
5 secondary outcomes
Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3
Time frame: Baseline and month 3
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
Time frame: Baseline and month 3
SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3
Time frame: Baseline and month 3
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3
Time frame: Baseline and month 3
Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3
Time frame: Baseline and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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.
BANU ORDAHAN principal investigator
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity laser therapy in people with Knee Osteoarthritis and Laser Therapy, run by Necmettin Erbakan 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 1 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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. Some participants in this study may receive a placebo. 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 BANU ORDAHAN (5058741256, banuordahan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3 (time frame: Baseline and month 3). 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 28 Sep 2022.