| CTRI Number |
CTRI/2025/03/081662 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Compare the Effectiveness of Mulligan Mobilization Technique and Traditional Therapy on Knee Function and Movement in People with Chronic Osteoarthritis – A Comparison Study |
|
Scientific Title of Study
|
A Study to Assess the Effectiveness of Mulligan Mobilization Technique Versus Conventional Therapy on Functional Performance and Mobility in Subjects with Chronic Osteoarthritis Knee – A Comparative Study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Mansoureh Mobaraki |
| Designation |
Post Gradute |
| Affiliation |
RV College of Physiotherapy |
| Address |
RV College of Physiotherapy Department of Musculoskeletal Sciences Room No 03
Bangalore KARNATAKA 560011 India |
| Phone |
8792038383 |
| Fax |
|
| Email |
sourimobaraki@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Archana P |
| Designation |
Associated Professor |
| Affiliation |
RV College of Physiotherapy |
| Address |
RV College of Physiotherapy Department of Musculoskeletal Sciences Room No 03
Bangalore KARNATAKA 560011 India |
| Phone |
8095347575 |
| Fax |
|
| Email |
archanap.rvcp@rvei.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Archana P |
| Designation |
Associated Professor |
| Affiliation |
RV College of Physiotherapy |
| Address |
RV College of Physiotherapy Department of Musculoskeletal Sciences Room No 03
Bangalore KARNATAKA 560011 India |
| Phone |
8095347575 |
| Fax |
|
| Email |
archanap.rvcp@rvei.edu.in |
|
|
Source of Monetary or Material Support
|
| RV College of Physiotherapy
No CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bengaluru Karnataka India 560011 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana P |
RV College of Physiotherapy |
RV College of Physiotherapy Department of Musculoskeletal Sciences Room No 03 Bangalore KARNATAKA |
8095347575
archanap.rvcp@rvei.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RV Institution Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
exercises (strengthening 15-20 reptations) + IFT (10 minutes) 3days/ 4 weeks |
| Intervention |
Mulligan Mobilization |
Mulligan mobilization with movements 3 sets of 6-10 repetitions for 3 days/ 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with chronic OA knee & Subjects with grade 2 and Grade 3 based on kellgren and Lawrence Radiographic scale
Age group 50-70 years
All genders
Subjects willing to participate as volunteers and who fill the consent form
Score of WOMAC outcome measure to identify moderate to chronic OA knee
|
|
| ExclusionCriteria |
| Details |
Subjects with any neurological condition
Subjects with undergoing any form of surgeries
Subjects with other knee pathologies and injuries
Subjects with recent fracture/other trauma of lower limb
Subjects with contraindication to manual therapy
Subjects with any lower limb deformities & any recent surgeries
Subjects taken on priority
Subjects with received Knee rehabilitation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Western Ontario McMaster University Arthritis Index Score (WOMAC) |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Locomotive Syndrome Risk Questionnaire |
At baseline & after 4 weeks |
• Time up & Go Test(TUG)
• Sit to Stand
• Gait Speed Test
|
At baseline & after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION
Osteoarthritis is a
chronic degenerative condition with multiple causes, it is characterized by the
degradation of articular cartilage, bone enlargement around the edges,
thickening of bone underneath the cartilage, and various biochemical and
structural changes in the synovial membrane and joint capsule.1
Osteoarthritis, the second most prevalent rheumatologic condition, it is the
predominant joint disorder in India, affecting between 22% to 39% of the
population. Although it is more prevalent in women, its occurrence escalates
notably with advancing age.1
From a clinical perspective,
osteoarthritis of the knee manifests through pain experienced during
weight-bearing, tenderness, limited range of motion, crepitus, occasional
swelling, and fluctuating levels of local inflammation.2Pain, being the predominant symptom, imposes substantial
social, psychological, and financial burdens on patients, necessitating medical
attention and rehabilitation, which can further strain their finances. 2
OA is classified into two groups according to its etiology: primary (idiopathic
or non-traumatic) and secondary (usually due to trauma or mechanical
misalignment). The severity of the disease can also be graded according to the
radiographical findings by the Kellgren–Lawrence (KL) system described in 1957.3
An evidence-based management approach should involve
educating patients about osteoarthritis (OA) and its management. This education
should include information on pain management, methods to improve function,
reduce disability, and strategies to slow down the progression of the disease.4Physiotherapy focuses on achieving proper posture and
enhancing muscle strength through various techniques, including manual therapy
such as mobilization, along with exercises to strengthen muscles and stretch
soft tissues. In the case of knee osteoarthritis (OA), the objective of
physical therapy is to alleviate pain, preserve joint function, and restore or
maintain normal joint activity.5
Mobilization with Movement (MWM) is a manual therapy technique frequently
employed in the treatment of musculoskeletal conditions. Developed by Brian
Mulligan, it offers a novel approach to addressing a range of soft tissue
issues in both upper and lower limb joints. This technique involves executing
pain-free physiological movements while applying accessory glides in the
direction opposite to the previously painful movement, with the aim of
achieving maximum improvement.6Hence, Mobilization with Movement (MWM) involves the
therapist administering a corrective technique by applying a passive accessory
glide perpendicular to the joint plane to address positional issues.
Simultaneously, the patient actively executes the problematic movement
repeatedly. Throughout this process, the goal is for pain to consistently
diminish or vanish, and for pain-free function to be reinstated.7
Osteoarthritis can significantly impact functional performance and mobility,
presenting a considerable challenge to individuals affected by the condition.
As the disease progresses, the degeneration of cartilage and changes in joint
structure can lead to stiffness, pain, and reduced range of motion, all of
which can profoundly affect day-to-day activities. Tasks that once seemed
effortless, such as walking, climbing stairs, or even getting out of a chair,
may become arduous and painful.Furthermore, osteoarthritis often causes muscle weakness and
imbalance around the affected joint, further compromising mobility and
stability. This can lead to a vicious cycle where reduced activity due to pain
and limitations exacerbates muscle weakness, ultimately worsening functional
performance. As mobility declines, individuals may experience decreased
independence and quality of life, impacting not only physical health but also
mental well-being.
However, proactive management strategies, including physical therapy, exercise,
weight management, and joint protection techniques, can play a crucial role in
mitigating the impact of osteoarthritis on functional performance and mobility.
By improving muscle strength, flexibility, and joint stability, these
interventions can help individuals maintain or regain independence in daily
activities, enhancing their overall quality of life despite the challenges
posed by osteoarthritis.
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