Knee OsteoarthritisNCT06233955
Effect of Maitland Mobilization With Low Level Laser Therapy in Treatment of Patients With Knee Osteoarthritis
A study testing Low Level laser therapy and Maitland mobilization technique in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Osteoarthritis is a common cause of chronic pain and disability in elderly people. Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Low Level laser therapy and Maitland mobilization technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Mar 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with proven bilateral Knee OA with age range 50- 65 years according to the American College of Rheumatology criteria.
- 2- Only patients with X-ray stages II and III osteoarthritis selected according to Kellgren \& Lawrence classification system.
- 3- BMI equal to or less than 30 . 4- Patients with Knee pain lasted at least 6 months with intensity at least 3 on VAS scale in activities such as going up-and downstairs, sitting and squatting.
- 5- Patients with normal mental state. 6- Patients who are not participating in physical therapy in the recent 3 months.
- .
Who cannot join
- Patient with history of gout, infection, tumour, autoimmune diseases, trauma or other causes of knee pain or knee deformities.
- Patient with neurologic dysfunction, or with history of chronic disease that may affect the study.
- Patient with history of knee intra-articular injection in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Osteoarthritis is a common cause of chronic pain and disability in elderly people.
Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis.
Design: Pre-test post-test randomized control trial.
Read the detailed description
Knee OA is associated with pain and disability, high treatment costs, decreased productivity, and absence from work and thus has a substantial and growing burden on society Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis.
Participants: Seventy five subjects of both genders with age range from 50 to 65 years, with proven bilateral knee OA diagnosed and referred by orthopaedist were recruited for the study and randomly assigned into three groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- Low Level laser therapy, Maitland mobilization technique
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level laser therapyDevice
Also called LLLT
is a non-invasive light source treatment that generates a single wavelength of light. It emits no heat, sound, or vibration. It is also called photobiology or bio-stimulation
Maitland mobilization techniqueOther
is a process of examination; assessment and treatment of musculoskeletal disorders by manipulative physiotherapy where a chain of oscillatory joint mobilization grades based on the pathological limit of tissue are used
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received LLLT and Maitland mobilization technique along with conventional physical therapy, Receives: Device: Low Level laser therapy; Other: Maitland mobilization technique |
| Group B | Experimental | received LLLT and conventional physical therapy Receives: Device: Low Level laser therapy |
| Group C | Experimental | received Maitland mobilization and conventional physical therapy. Receives: Other: Maitland mobilization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Is a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients were instructed to draw a vertical mark on the line indicating their pain level where zero mean no pain and 10 means worst imaginable pain
Measured: Four weeks
Pressure Algometer
is a handheld pressure algometer that responds linearly to force application between 0 and 5 Kg and it has a 1-cm2 round rubber tip.
Measured: Four weeks
Knee digital goniometry
Baseline digital absolute + axis TM goniometer was used which consisted of one movable arm and one fixed arm and fulcrum
Measured: Four weeks
Secondary outcomes (1)
Knee injury and osteoarthritis outcome score short form
consists of a seven items measure of physical function descended from the items of the function, daily living and function, sports and recreational activity subscales of the KOOS Item responses are coded from 0 to 4, none to extreme respectively. The questionnaire is scored by summing the raw response (range 0-28) and then using the nomogram so the raw score is converted to a true interval score (0-100) where zero means no difficulty and 100 means extreme difficulty
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jul 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Kamal Abdel-Shakour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233955
- Sponsor's protocol ID
- Maitland Mobilization and LLLT
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maitland Mobilization With Low Level Laser Therapy in Treatment of Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06233955
- Acronym / sponsor ID
- Maitland Mobilization and LLLT
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 31 Jan 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.
Background: Osteoarthritis is a common cause of chronic pain and disability in elderly people.
Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis.
Design: Pre-test post-test randomized control trial.
Detailed description
Knee OA is associated with pain and disability, high treatment costs, decreased productivity, and absence from work and thus has a substantial and growing burden on society Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis.
Participants: Seventy five subjects of both genders with age range from 50 to 65 years, with proven bilateral knee OA diagnosed and referred by orthopaedist were recruited for the study and randomly assigned into three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Low Level laser therapy, Other: Maitland mobilization techniqueGroup A received LLLT and Maitland mobilization technique along with conventional physical therapy, |
| Group B | Experimental | Device: Low Level laser therapyreceived LLLT and conventional physical therapy |
| Group C | Experimental | Other: Maitland mobilization techniquereceived Maitland mobilization and conventional physical therapy. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with proven bilateral Knee OA with age range 50- 65 years according to the American College of Rheumatology criteria.
- 2- Only patients with X-ray stages II and III osteoarthritis selected according to Kellgren \& Lawrence classification system.
- 3- BMI equal to or less than 30 . 4- Patients with Knee pain lasted at least 6 months with intensity at least 3 on VAS scale in activities such as going up-and downstairs, sitting and squatting.
- 5- Patients with normal mental state. 6- Patients who are not participating in physical therapy in the recent 3 months.
- .
Key exclusion criteria (3 listed)
- Patient with history of gout, infection, tumour, autoimmune diseases, trauma or other causes of knee pain or knee deformities.
- Patient with neurologic dysfunction, or with history of chronic disease that may affect the study.
- Patient with history of knee intra-articular injection in the past 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 |
|---|---|---|
| Low Level laser therapyAlso: LLLTis a non-invasive light source treatment that generates a single wavelength of light. It emits no heat, sound, or vibration. It is also called photobiology or bio-stimulation | Device | Group A, Group B |
| Maitland mobilization techniqueis a process of examination; assessment and treatment of musculoskeletal disorders by manipulative physiotherapy where a chain of oscillatory joint mobilization grades based on the pathological limit of tissue are used | Other | Group A, Group C |
Primary outcome
Visual analogue scale
Time frame: Four weeks
Is a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients were instructed to draw a vertical mark on the line indicating their pain level where zero mean no pain and 10 means worst imaginable pain
Pressure Algometer
Time frame: Four weeks
is a handheld pressure algometer that responds linearly to force application between 0 and 5 Kg and it has a 1-cm2 round rubber tip.
Knee digital goniometry
Time frame: Four weeks
Baseline digital absolute + axis TM goniometer was used which consisted of one movable arm and one fixed arm and fulcrum
1 secondary outcome
Knee injury and osteoarthritis outcome score short form
Time frame: Four weeks
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 31 Jan 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.
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 Low Level laser therapy and Maitland mobilization technique in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
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 3 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 31 Jan 2024. 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 Egypt. 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?
Visual analogue scale (time frame: Four weeks). The study lists 3 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 31 Jan 2024.