Chronic Knee OsteoarthritisNCT04751253
High Intensity Laser and Exercises in Knee OA
A study testing High Intensity Laser Therapy in people with Chronic Knee Osteoarthritis, run by Cairo University.
Trial summary
The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Chronic Knee Osteoarthritis
- What is being tested?
- High Intensity Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2021to 1 Jan 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
- Aged between 50- 70 years
- Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
- Body mass index (BMI) ≤30 kg/m2.
- Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university
Who cannot join
- Patients will be excluded if they have the following conditions:
- History of joint replacement.
- Symptoms or signs suggestive of another cause of knee pain.
- Rheumatoid arthritis.
- Steroid injection or knee surgery (previous six months).
- acute inflammation around knee joint.
- Underlying disease such as malignancy.
- Infection or systemic disease of musculoskeletal system
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Combined Effect Of Different Doses Of High-Intensity Laser And Traditional Exercise On Pain And Function In Patients With Chronic Knee Osteoarthritis
The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
Read the detailed description
Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.
Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.
As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .
- Conditions
- Chronic Knee Osteoarthritis
- Being tested
- High Intensity Laser Therapy
- Keywords
- knee, osteoarthritis, HILT, exercise, pain, function
- Medical subject headings
- Osteoarthritis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser TherapyDevice
different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
| Study group | Role | What they receive |
|---|---|---|
| 1500 J + exercises | Active comparator | consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises. Receives: Device: High Intensity Laser Therapy |
| 3000 J + exercises | Active comparator | consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises. Receives: Device: High Intensity Laser Therapy |
| exercises + sham LASER | Sham comparator | consist of 17 patients, they will apply exercises plus sham LASER. Receives: Device: High Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
pain intensity
Measured: 8 weeks
The functional disability assessment
The Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start2 Feb 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751253
- Sponsor's protocol ID
- HILT and Knee OA
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect Of Different Doses Of High-Intensity Laser And Traditional Exercise On Pain And Function In Patients With Chronic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04751253
- Acronym / sponsor ID
- HILT and Knee OA
- Conditions
- Chronic Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, HILT, exercise, pain, function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Feb 2021 (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 purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
Detailed description
Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.
Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.
As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1500 J + exercises | Active comparator | Device: High Intensity Laser Therapyconsist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises. |
| 3000 J + exercises | Active comparator | Device: High Intensity Laser Therapyconsist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises. |
| exercises + sham LASER | Sham comparator | Device: High Intensity Laser Therapyconsist of 17 patients, they will apply exercises plus sham LASER. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
- Aged between 50- 70 years
- Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
- Body mass index (BMI) ≤30 kg/m2.
- Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Key exclusion criteria (8 listed)
- History of joint replacement.
- Symptoms or signs suggestive of another cause of knee pain.
- Rheumatoid arthritis.
- Steroid injection or knee surgery (previous six months).
- acute inflammation around knee joint.
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 Therapydifferent doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA. | Device | 1500 J + exercises, 3000 J + exercises, exercises + sham LASER |
Primary outcome
visual analogue scale
Time frame: 8 weeks
pain intensity
The functional disability assessment
Time frame: 8 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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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 Intensity Laser Therapy in people with Chronic 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 6 inclusion and 8 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 12 Feb 2021. 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 Mona M ibrahim, professor (+201002992613, mona.ibrahiem@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 8 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 12 Feb 2021.