Knee OsteoarthritisNCT05812898
Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
A study testing exercises and myofascial release in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- exercises and myofascial release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 May 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L).
- The age of the participants will range from 45 to 60 years old .
- BMI ranged from 20-30 kg/m2
Who cannot join
- Severe knee OA (grade IV according to K/L classification).
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Patients receiving oral or injected corticosteroids for the last 3 months .
- History of knee surgery/fracture.
- Patients with ACL and meniscus injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis
Read the detailed description
: Knee osteoarthritis (KOA) also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage.
The myofascial meridian is a new approach to the facial restriction .the knee capsules, the adductor muscles and the tipialis posterior are part of the deep front line which is a line of the myofascial meridian.
Exercise is the highest evidence in the treatment of knee osteoarthritis. The myofascial release is effective in the treatment of knee osteoarthritis so the study will investigate the effect of adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- exercises, myofascial release
- Keywords
- myofascial release, Knee osteoarthritis, Deep front line
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
strengthening of the gluteus maximus and medius, calf muscles stretching for calf and hamstring muscles
myofascial releaseOther
myofascial release using instrument assisted soft tissue mobilization
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | The control group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee Receives: Other: exercises |
| study group | Experimental | The study group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee, plus myofascial release technique of the deep front line. Receives: Other: exercises; Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The scale that will be used the visual analogue scale;each subject will instructed to record pain intensity on line of 100mm. Starting from no pain on the leftto the most sever pain imaginable on the right Patient will choose the point which describe his pain.the more the score toward the end the more severe pain
Measured: up to four weeks
function
The Arabic version of reduced Western Ontario and McMasters University Osteoarthritis Index (ArWOMAC) index will be used to measure functional disability.is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
- Pain (5 items): During walking, using stairs, in bed, sitting or lying, and standing upright
- Stiffness (2 items): After first waking and later in the day Physical Function (17 items).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
Measured: up to four weeks
rang of motion
using digital inclinometer
Measured: up to four weeks
joint position sense
using digital inclinometer for target angle 30 degree knee flexion
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Apr 2023
- Study completion15 May 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
- Model description
- exercise plus myofascial release of the adductor and tipialis posterior muscles.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda mohamed Ahmed, Cairo University
- Investigators
- hoda m Ahmed, bachelor, Principal investigator, phyical therapist at Cairo university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812898
- Sponsor's protocol ID
- P.T.REC/012/004281
- Status last verified
- Feb 2024
- First submitted
- 1 Apr 2023
- Last updated
- 7 Feb 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05812898
- Acronym / sponsor ID
- P.T.REC/012/004281
- Conditions
- Knee Osteoarthritis
- Keywords
- myofascial release, Knee osteoarthritis, Deep front line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Apr 2023 (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 the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis
Detailed description
: Knee osteoarthritis (KOA) also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage.
The myofascial meridian is a new approach to the facial restriction .the knee capsules, the adductor muscles and the tipialis posterior are part of the deep front line which is a line of the myofascial meridian.
Exercise is the highest evidence in the treatment of knee osteoarthritis. The myofascial release is effective in the treatment of knee osteoarthritis so the study will investigate the effect of adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- exercise plus myofascial release of the adductor and tipialis posterior muscles.
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: exercisesThe control group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee |
| study group | Experimental | Other: exercises, Other: myofascial releaseThe study group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee, plus myofascial release technique of the deep front line. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L).
- The age of the participants will range from 45 to 60 years old .
- BMI ranged from 20-30 kg/m2
Key exclusion criteria (5 listed)
- Severe knee OA (grade IV according to K/L classification).
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Patients receiving oral or injected corticosteroids for the last 3 months .
- History of knee surgery/fracture.
- Patients with ACL and meniscus injury
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 |
|---|---|---|
| exercisesstrengthening of the gluteus maximus and medius, calf muscles stretching for calf and hamstring muscles | Other | control group, study group |
| myofascial releasemyofascial release using instrument assisted soft tissue mobilization | Other | study group |
Primary outcome
pain intensity
Time frame: up to four weeks
The scale that will be used the visual analogue scale;each subject will instructed to record pain intensity on line of 100mm. Starting from no pain on the leftto the most sever pain imaginable on the right Patient will choose the point which describe his pain.the more the score toward the end the more severe pain
function
Time frame: up to four weeks
The Arabic version of reduced Western Ontario and McMasters University Osteoarthritis Index (ArWOMAC) index will be used to measure functional disability.is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): During walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): After first waking and later in the day Physical Function (17 items).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
rang of motion
Time frame: up to four weeks
using digital inclinometer
joint position sense
Time frame: up to four weeks
using digital inclinometer for target angle 30 degree knee flexion
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 7 Feb 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.
hoda m Ahmed, bachelor principal investigator
phyical therapist at Cairo university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises and myofascial release 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 3 inclusion and 5 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 7 Feb 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. 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?
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?
pain intensity (time frame: up to four weeks). The study lists 4 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 7 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.