Knee OsteoarthritisNCT05338840
Mulligan Rotational Movement Versus Medial Gapping Technique in Patients With Knee Osteoarthritis
A study testing MULLIGAN ROTATIONAL MOVEMENT and Medial gapping technique in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Knee osteoarthritis is a progressive degenerative and non-inflammatory joint disorder. Due to the extensive use and stress placed on knee joint, it is a common site for painful disorders such as knee osteoarthritis. It is seen that medial side of knee is most commonly affected because of weight bearing on medial side. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MULLIGAN ROTATIONAL MOVEMENT and Medial gapping technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to 30 Jul 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-traumatic stiffness of knee
- Restricted range of knee flexion
- Patients with restricted ROM and with Grade 3 or more than three power of knee muscle
Who cannot join
- Patients with hyper mobile and unstable joints
- Joint infection and loosening,
- Soft tissue injuries around knee joints and
- Other complications of post-fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mulligan Rotational Movement Versus Medial Gapping Technique on Pain, Range of Motion and Disability in Patients With Knee Osteoarthritis
Knee osteoarthritis is a progressive degenerative and non-inflammatory joint disorder. Due to the extensive use and stress placed on knee joint, it is a common site for painful disorders such as knee osteoarthritis. It is seen that medial side of knee is most commonly affected because of weight bearing on medial side. Symptomatically, the knee joint is most commonly affected in osteoarthritis because it requires support, high mobility, and insufficient internal stability. Osteoarthritis of the knee joint affects three parts of the knee joint (medial, lateral, and patellar-femoral joints) and develops slowly, usually over 10-15 years, interfering with daily activities Slow and gentle movements like Tai Chi, Isometric, iso-kinetic and isotonic exercises are considered helpful in increasing joint range of motion and physical function. Stretching and aquatic therapy can also decrease pain and enhance joint flexibility. The aim of this study is to compare the effects of Mulligan rotational movement vs Medial gapping technique on pain, range of motion and disability in knee osteoarthritis.
This study will be a randomized control trial and will be conducted in Riphah clinics and LGH. The study will be completed within the time duration of six months. Non-probability convenient sampling technique will be used to collect the data. Those who will meet the inclusion criteria will be recruited in the group. The sample size of patients with knee osteoarthritis will be taken in this study to find the effects of Mulligan Rotational movements vs. Medial gap technique, aged between 20-40 years, will be allocated to an intervention or control group. The scales used for recording findings will be goniometer, visual analogue scale and modified disability index. Subjects will randomly divide into control group called group A Taking Mulligan therapy and Interventional group called group B taking Median Gapping Technique. 12 sessions over 6 weeks were performed on both groups. Data analysis will be done by SPSS version 25.
- Conditions
- Knee Osteoarthritis
- Being tested
- MULLIGAN ROTATIONAL MOVEMENT, Medial gapping technique
- Keywords
- Mulligan Rotational Movement, Medial Gapping Technique, Pain, Range of Motion, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULLIGAN ROTATIONAL MOVEMENTOther
12 sessions over 6 weeks
Medial gapping techniqueOther
12 sessions over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| MULLIGAN | Experimental | ROTATIONAL MOVEMENT Receives: Other: MULLIGAN ROTATIONAL MOVEMENT |
| Medial gapping technique | Experimental | Medial gapping technique Receives: Other: Medial gapping technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The Numeric pain rating scale is a tool that is used to measure pain.it has a range from 1-10
Measured: 6 weeks
GONIOMETR
Goniometer to measure range of motion. Goniometer is a tool to measure the flexibility of a joint, which is important for injury prevention and execution of many therapeutic movements.
Measured: 6 weeks
Disability Index Scale
Disability Index Scale to measure disability that consist of 10 items, concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Oct 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, t-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338840
- Sponsor's protocol ID
- REC/Lhr/22/0142 Iqra
- Status last verified
- Dec 2022
- First submitted
- 15 Apr 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
PubMed 29035179Lalnunpuii A, Sarkar B, Alam S, Equebal A, Biswas A. Efficacy of mulligan mobilisation as compared to Maitland mobilisation in females with knee osteoarthritis: a double blind randomized controlled trial. International Journal of Therapies and Rehabilitation Research. 2017;6(2):37.
Nazir SNB, Rathore FA. Efficacy of Mulligan joint mobilizations and trunk stabilization exercises versus isometric knee strengthening in the management of knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 May 7;16(1):105. doi: 10.1186/s13102-024-00893-7.
PubMed 38715135Mehmood Z, Anwar N, Tauqeer S, Shabbir M, Khalid K, Mehmood S. Comparison of Maitland Mobilization and Mulligan Mobilization with Movement in Knee Osteoarthritis Patients. Pakistan Journal of Medical Research. 2021;60(3):126-30
Rao RV, Balthillaya G, Prabhu A, Kamath A. Immediate effects of Maitland mobilization versus Mulligan Mobilization with Movement in Osteoarthritis knee- A Randomized Crossover trial. J Bodyw Mov Ther. 2018 Jul;22(3):572-579. doi: 10.1016/j.jbmt.2017.09.017. Epub 2017 Sep 28.
PubMed 30100279Epskamp S, Dibley H, Ray E, Bond N, White J, Wilkinson A, et al. Range of motion as an outcome measure for knee osteoarthritis interventions in clinical trials: an integrated review. Physical Therapy Reviews. 2020;25(5-6):462-81.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan Rotational Movement Versus Medial Gapping Technique on Pain, Range of Motion and Disability in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05338840
- Acronym / sponsor ID
- REC/Lhr/22/0142 Iqra
- Conditions
- Knee Osteoarthritis
- Keywords
- Mulligan Rotational Movement, Medial Gapping Technique, Pain, Range of Motion, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 21 Apr 2022 (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.
Knee osteoarthritis is a progressive degenerative and non-inflammatory joint disorder. Due to the extensive use and stress placed on knee joint, it is a common site for painful disorders such as knee osteoarthritis. It is seen that medial side of knee is most commonly affected because of weight bearing on medial side. Symptomatically, the knee joint is most commonly affected in osteoarthritis because it requires support, high mobility, and insufficient internal stability. Osteoarthritis of the knee joint affects three parts of the knee joint (medial, lateral, and patellar-femoral joints) and develops slowly, usually over 10-15 years, interfering with daily activities Slow and gentle movements like Tai Chi, Isometric, iso-kinetic and isotonic exercises are considered helpful in increasing joint range of motion and physical function. Stretching and aquatic therapy can also decrease pain and enhance joint flexibility. The aim of this study is to compare the effects of Mulligan rotational movement vs Medial gapping technique on pain, range of motion and disability in knee osteoarthritis.
This study will be a randomized control trial and will be conducted in Riphah clinics and LGH. The study will be completed within the time duration of six months. Non-probability convenient sampling technique will be used to collect the data. Those who will meet the inclusion criteria will be recruited in the group. The sample size of patients with knee osteoarthritis will be taken in this study to find the effects of Mulligan Rotational movements vs. Medial gap technique, aged between 20-40 years, will be allocated to an intervention or control group. The scales used for recording findings will be goniometer, visual analogue scale and modified disability index. Subjects will randomly divide into control group called group A Taking Mulligan therapy and Interventional group called group B taking Median Gapping Technique. 12 sessions over 6 weeks were performed on both groups. Data analysis will be done by SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MULLIGAN | Experimental | Other: MULLIGAN ROTATIONAL MOVEMENTROTATIONAL MOVEMENT |
| Medial gapping technique | Experimental | Other: Medial gapping techniqueMedial gapping technique |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post-traumatic stiffness of knee
- Restricted range of knee flexion
- Patients with restricted ROM and with Grade 3 or more than three power of knee muscle
Key exclusion criteria (4 listed)
- Patients with hyper mobile and unstable joints
- Joint infection and loosening,
- Soft tissue injuries around knee joints and
- Other complications of post-fracture
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 ROTATIONAL MOVEMENT12 sessions over 6 weeks | Other | MULLIGAN |
| Medial gapping technique12 sessions over 6 weeks | Other | Medial gapping technique |
Primary outcome
NPRS
Time frame: 6 weeks
The Numeric pain rating scale is a tool that is used to measure pain.it has a range from 1-10
GONIOMETR
Time frame: 6 weeks
Goniometer to measure range of motion. Goniometer is a tool to measure the flexibility of a joint, which is important for injury prevention and execution of many therapeutic movements.
Disability Index Scale
Time frame: 6 weeks
Disability Index Scale to measure disability that consist of 10 items, concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
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 20 Dec 2022.
- Background: PubMed 29035179Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- BackgroundLalnunpuii A, Sarkar B, Alam S, Equebal A, Biswas A. Efficacy of mulligan mobilisation as compared to Maitland mobilisation in females with knee osteoarthritis: a double blind randomized controlled trial. International Journal of Therapies and Rehabilitation Research. 2017;6(2):37.
- Background: PubMed 38715135Nazir SNB, Rathore FA. Efficacy of Mulligan joint mobilizations and trunk stabilization exercises versus isometric knee strengthening in the management of knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 May 7;16(1):105. doi: 10.1186/s13102-024-00893-7.
- BackgroundMehmood Z, Anwar N, Tauqeer S, Shabbir M, Khalid K, Mehmood S. Comparison of Maitland Mobilization and Mulligan Mobilization with Movement in Knee Osteoarthritis Patients. Pakistan Journal of Medical Research. 2021;60(3):126-30
- Background: PubMed 30100279Rao RV, Balthillaya G, Prabhu A, Kamath A. Immediate effects of Maitland mobilization versus Mulligan Mobilization with Movement in Osteoarthritis knee- A Randomized Crossover trial. J Bodyw Mov Ther. 2018 Jul;22(3):572-579. doi: 10.1016/j.jbmt.2017.09.017. Epub 2017 Sep 28.
- BackgroundEpskamp S, Dibley H, Ray E, Bond N, White J, Wilkinson A, et al. Range of motion as an outcome measure for knee osteoarthritis interventions in clinical trials: an integrated review. Physical Therapy Reviews. 2020;25(5-6):462-81.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Recruiting
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
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.
hina gul, t-DPT principal investigator
Riphah International 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 ROTATIONAL MOVEMENT and Medial gapping technique in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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 4 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 20 Dec 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 Pakistan. 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?
NPRS (time frame: 6 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?
On the ClinicalTrials.gov record for NCT05338840, which also lists 6 linked publications.
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 20 Dec 2022.