Physical FittnessNCT01756378
Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis
A study testing joint mobilization with movement and traditional physical therapy program in people with Physical Fittness, run by Cairo University at 1 site in Egypt.
Trial summary
we tested the effect of adding the mobilization with movement to the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA. study hypothesis: there will be no significant difference between traditional physical therapy program and the mobilization with movement plus the… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Physical Fittness
- What is being tested?
- joint mobilization with movement and traditional physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2011to Mar 2012
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with unilateral osteoarthritis knee age ranges from 30-60 years old grade 1 or 2 on Kallegren and Lawerance scale. body mass index not more than 36
Who cannot join
- history of major knee injury or surgery, tumors, osteoporosis, patients undertaking analgesics, patients with uncontrolled hypertension, bleeding, dermatological problems, psychiatric disorders, hearing problems, cognitive problems and pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
we tested the effect of adding the mobilization with movement to the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA.
study hypothesis: there will be no significant difference between traditional physical therapy program and the mobilization with movement plus the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA
- Conditions
- Physical Fittness
- Being tested
- joint mobilization with movement, traditional physical therapy program
- Keywords
- Mobilization with movement,knee osteoarthritis,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint mobilization with movementProcedure or surgery
Also called Muligan's technique
traditional physical therapy programProcedure or surgery
I.R, stretching exercises, strengthen exercises
| Study group | Role | What they receive |
|---|---|---|
| Muligan mobilization with movement | Experimental | Interventions are:
medial glide mobilization with movement lateral glide mobilization with movement rotation mobilization with movement dorsal glide with active knee flexion Receives: Procedure: joint mobilization with movement; Procedure: traditional physical therapy program |
| traditional physical therapy program | Active comparator | Infra-red, stretching exercises, strengthening exercises, Receives: Procedure: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
measured by visual analogue scale
Measured: baseline and up to 10 months
functional disability
measured by WOMAC scale
Measured: baseline and up to 10 months
Range of motion for the knee joint
measured by Gynom digital electrogoniometer
Measured: baseline and up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FittnessStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdolin Mishel Samy Saad Shenouda, Cairo University
- Investigators
- Magdolin M Shenouda, Ph.D, Study director, Faculty of Physical Therapy, Cairo Un iversityReda K Gad ElHak, Ms.C, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756378
- Sponsor's protocol ID
- REC/012/003
- Status last verified
- Dec 2012
- First submitted
- 20 Dec 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01756378
- Acronym / sponsor ID
- REC/012/003
- Conditions
- Physical Fittness
- Keywords
- Mobilization with movement,knee osteoarthritis,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Dec 2012 (estimated)
- 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.
we tested the effect of adding the mobilization with movement to the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA.
study hypothesis: there will be no significant difference between traditional physical therapy program and the mobilization with movement plus the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muligan mobilization with movement | Experimental | Procedure: joint mobilization with movement, Procedure: traditional physical therapy programInterventions are: medial glide mobilization with movement lateral glide mobilization with movement rotation mobilization with movement dorsal glide with active knee flexion |
| traditional physical therapy program | Active comparator | Procedure: traditional physical therapy programInfra-red, stretching exercises, strengthening exercises, |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with unilateral osteoarthritis knee age ranges from 30-60 years old grade 1 or 2 on Kallegren and Lawerance scale. body mass index not more than 36
Key exclusion criteria (1 listed)
- history of major knee injury or surgery, tumors, osteoporosis, patients undertaking analgesics, patients with uncontrolled hypertension, bleeding, dermatological problems, psychiatric disorders, hearing problems, cognitive problems and pacemaker.
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 |
|---|---|---|
| joint mobilization with movementAlso: Muligan's technique | Procedure or surgery | Muligan mobilization with movement |
| traditional physical therapy programI.R, stretching exercises, strengthen exercises | Procedure or surgery | Muligan mobilization with movement, traditional physical therapy program |
Primary outcome
pain
Time frame: baseline and up to 10 months
measured by visual analogue scale
functional disability
Time frame: baseline and up to 10 months
measured by WOMAC scale
Range of motion for the knee joint
Time frame: baseline and up to 10 months
measured by Gynom digital electrogoniometer
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 25 Dec 2012.
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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.
Magdolin M Shenouda, Ph.D study director
Faculty of Physical Therapy, Cairo Un iversity
Reda K Gad ElHak, Ms.C principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint mobilization with movement and traditional physical therapy program in people with Physical Fittness, 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 1 inclusion and 1 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 25 Dec 2012. 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?
pain (time frame: baseline and up to 10 months). 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 25 Dec 2012.