ExerciseNCT04540341
Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercise With Knee Osteoarthritis
A study testing Mulligan mobilization, Core stabilization and Conventional therapy in people with Exercise, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a chronic disease process characterized by degeneration and inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule. One of the most affected joints in OA is the knee joint, and the incidence of OA increases with age. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Exercise
- What is being tested?
- Mulligan mobilization, Core stabilization and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2020to 20 Apr 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with knee osteoarthritis
- To be in the age range of 40-70
- No lower extremity surgery in the last 6 months.
- Agree to participate in the study
Who cannot join
- Having had hip-knee replacement surgery
- Surgery planned in the last 6 months
- Having received physical therapy in the last 6 months
- Having uncontrollable hypertension and cardiac problems
- Having been diagnosed with rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercises in Female Patients With Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.
Osteoarthritis (OA) is a chronic disease process characterized by degeneration and inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule. One of the most affected joints in OA is the knee joint, and the incidence of OA increases with age.
Different treatment approaches are used in the treatment of osteoarthritis. The aim of the study is to examine the effectiveness of Mulligan technique and core exercises applied to female patients with knee osteoarthritis. In addition, the investigators did not find any study examining the effect of Mulligan technique on static balance in the treatment of OA. This is the secondary aim of the study.
- Conditions
- Exercise
- Being tested
- Mulligan mobilization, Core stabilization, Conventional therapy
- Keywords
- Pain, Joint, Mulligan, Core stabilization
- Medical subject headings
- Motor Activity, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan mobilizationOther
Mulligan mobilization technique will be apply.
Core stabilizationOther
Core stabilization technique will be apply.
Conventional therapyOther
Conventional therapy exercise will be apply.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan mobilization group | Experimental | Painless movement Receives: Other: Mulligan mobilization |
| Core stabilization group | Experimental | Abdominal drawing-in maneuver Receives: Other: Core stabilization |
| conventional therapy group | Active comparator | Ultrasound TENS Hotpack Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Visual Analog Scale: This scale consists of a straight line with the end points defining extreme limits such as 'no pain at all', which is 0 cm, and 'pain as bad as it could be', which is 10cm.
Measured: 10 minutes
Range of motion assessment
Goniometric measurement
Measured: 10 minutes
muscle strength assessment
by handheld device (Commander Powertrack II brand)
Measured: 10 minutes
functional level assessment
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 5 minutes
aerobic endurance assessment
6 minute walk test
Measured: 6 minutes
balance assessment
Stand on one leg test
Measured: 5 minutes
Timed Up& Go Test
Timed Up\& Go Test
Measured: 5 minutes
assessment of quality of life survey
Nottingham Health Profile
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start14 Aug 2020
- Primary completion1 Feb 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem BUKE, Pamukkale University
- Investigators
- Meryem Buke, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540341
- Sponsor's protocol ID
- 60116787-020/48052
- Status last verified
- Apr 2022
- First submitted
- 27 Aug 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercises in Female Patients With Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.
- ClinicalTrials.gov ID
- NCT04540341
- Acronym / sponsor ID
- 60116787-020/48052
- Conditions
- Exercise
- Keywords
- Pain, Joint, Mulligan, Core stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 7 Sep 2020 (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.
Osteoarthritis (OA) is a chronic disease process characterized by degeneration and inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule. One of the most affected joints in OA is the knee joint, and the incidence of OA increases with age.
Different treatment approaches are used in the treatment of osteoarthritis. The aim of the study is to examine the effectiveness of Mulligan technique and core exercises applied to female patients with knee osteoarthritis. In addition, the investigators did not find any study examining the effect of Mulligan technique on static balance in the treatment of OA. This is the secondary aim of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan mobilization group | Experimental | Other: Mulligan mobilizationPainless movement |
| Core stabilization group | Experimental | Other: Core stabilizationAbdominal drawing-in maneuver |
| conventional therapy group | Active comparator | Other: Conventional therapyUltrasound TENS Hotpack |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with knee osteoarthritis
- To be in the age range of 40-70
- No lower extremity surgery in the last 6 months.
- Agree to participate in the study
Key exclusion criteria (5 listed)
- Having had hip-knee replacement surgery
- Surgery planned in the last 6 months
- Having received physical therapy in the last 6 months
- Having uncontrollable hypertension and cardiac problems
- Having been diagnosed with rheumatoid arthritis
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 |
|---|---|---|
| Mulligan mobilizationMulligan mobilization technique will be apply. | Other | Mulligan mobilization group |
| Core stabilizationCore stabilization technique will be apply. | Other | Core stabilization group |
| Conventional therapyConventional therapy exercise will be apply. | Other | conventional therapy group |
Primary outcome
Pain assessment
Time frame: 10 minutes
Visual Analog Scale: This scale consists of a straight line with the end points defining extreme limits such as 'no pain at all', which is 0 cm, and 'pain as bad as it could be', which is 10cm.
Range of motion assessment
Time frame: 10 minutes
Goniometric measurement
muscle strength assessment
Time frame: 10 minutes
by handheld device (Commander Powertrack II brand)
functional level assessment
Time frame: 5 minutes
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
aerobic endurance assessment
Time frame: 6 minutes
6 minute walk test
balance assessment
Time frame: 5 minutes
Stand on one leg test
Timed Up& Go Test
Time frame: 5 minutes
Timed Up\& Go Test
assessment of quality of life survey
Time frame: 5 minutes
Nottingham Health Profile
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 21 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Meryem Buke principal investigator
Pamukkale 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 Mulligan mobilization, Core stabilization and Conventional therapy in people with Exercise, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 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 21 Apr 2022. 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 Turkey (Türkiye). 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 assessment (time frame: 10 minutes). The study lists 8 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 21 Apr 2022.