NCT06971016

Brief Summary

This research analyzes the effectiveness of Mulligan mobilization in comparison to proprioceptive exercises for treating patients with mild to moderate Knee osteoarthritis whose condition falls under Kellgren and Lawrence grading system Grades 2 and 3. The current study evaluates these therapeutic approaches as a combined method during a 10-week assessment period which incorporates pain intensity measures, movement analysis and functional activities and balance performance together with quality of life improvement. The study implements a preliminary test followed by standardized evaluation tests to establish robust data for Knee osteoarthritis physical therapy strategies. The study population will include individuals diagnosed with knee OA, aged 40 years and above, clinically diagnosed mild to moderate primary OA in knee. Participants will be recruited from a physical therapy clinic, and will be screened for inclusion and exclusion criteria. Inclusion criteria will include diagnosed cases of knee OA with mild to moderate Grade of OA (According to Kellgren and Lawrence Scale) and the ability to walk without assistive devices for at least 50 feet. A total of 60 subjects will be chosen equally for three groups (Experimental Group A=Proprioceptive Exercises group), (Experimental Group B=Mulligan Mobilization Technique Group), and (Control Group C= Traditional physical therapy). Double blinding randomized selection through simple random sampling will determine all participants. Study will continue for 10 weeks and a total number of 30 treatment sessions will be given to each patient with 3 sessions per week. Session lasting an average of 40 minutes to an hour each. Assessment of the patients will be done at the beginning of 1st Session day and at the end of treatment of 30th Session day. The research site for this investigation is Physiotherapy Out-Patient Department at National Healthcare Centre, Karachi-Pakistan.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 15, 2025

Last Update Submit

May 17, 2025

Conditions

Keywords

OsteoarthritisKnee OsteoarthritisMulligan MobilizationProprioceptive trainingPainFunctional StatusKnee Managment

Outcome Measures

Primary Outcomes (4)

  • Knee Injury and Osteoarthritis Outcome Score

    The KOOS exists to measure both brief and persistent symptoms together with actual functions of people who have knee ligament damage or osteoarthritis. General healthcare providers rely on the KOOS tool as well as research investigators to track patient health evolution through registries and clinical use. This evaluation instrument contains five distinct subcategories which assess Pain as well as Symptoms alongside Activities of Daily Living (ADL) and Sports and Recreation Function (Sport/Rec) and Knee-Related Quality of Life (QOL). Each subscale in KOOS receives scoring on a 5-point Likert scale before the scores transform into a 0 to 100 scale representing extreme symptoms to no symptoms.

    10 weeks

  • Universal Goniometer

    Physical therapy practitioners use universal goniometers (UG) to conduct goniometry which stands as an necessary technique for measuring joint range of motion (ROM). A two-armed handheld device provides stable measured results through valid procedures if users adhere to specific placement protocols.

    10 weeks

  • Numeric Pain Rating Scale (NPRS)

    Through NPRS participants rate their pain levels on a 0 to 10 scale by choosing numbers that show no pain at 0 and maximum pain at 10. The pain intensity score is determined by the number that the participant selects.

    10 weeks

  • Berg Balance Scale (BBS)

    The Berg Balance Scale stands as a common instrument which evaluates testing both static and dynamic balance levels. The BBS created by Katherine Berg during 1989 contains 14 specific tasks that measure both sitting and standing and dynamic balance abilities of patients. Therapy participants receive scores ranging from 0 to 4 on each task distributed across a total rate of 56 points in the assessment process.

    10 weeks

Secondary Outcomes (1)

  • Quality of Life Short Form (SF-36)

    10 weeks

Study Arms (3)

Proprioceptive Exercises

EXPERIMENTAL

Proprioceptive exercises aim to enhance an individual's ability to perceive body position and movement in space, improving balance, stability, and injury prevention. These exercises have shown significant benefits for various populations, including institutionalized older adults, where they improved functional mobility, balance, gait, and reduced fall risk.

Other: Proprioceptive Exercises

Mulligan Mobilization Technique

ACTIVE COMPARATOR

The Mulligan Mobilization Technique, specifically Mobilization with Movement (MWM), is an effective manual therapy approach for treating musculoskeletal conditions. In knee osteoarthritis treatment, Mulligan mobilization was found to be more effective than Maitland technique in alleviating pain and improving function scores. The technique can be combined with other therapeutic measures such as conventional treatments and exercises for optimal results. Overall, Mulligan Mobilization Technique emerges as a promising intervention for various musculoskeletal conditions, offering pain relief and functional improvement.

Other: Mulligan Mobilization technique

Placebo

PLACEBO COMPARATOR

Traditional Physical Therapy

Other: Traditional Physical therapy

Interventions

i. Mulligan Mobilization for Medial Glide: During the treatment, the patient will be positioned in a prone (face-down) posture. To execute a medial glide, the therapist will position themselves on the side opposite to the target knee. They will place a belt around the patient's waist and lower leg, aligning the upper edge of the belt with the margin of the tibial joint. Using one hand to stabilize the thigh above the knee and the other hand to support the lower leg, the therapist will apply a medial force to the knee using the belt. The therapist will then instruct the patient to flex their knee while maintaining the glide. ii. Mulligan Mobilization for Lateral Glide: To administer a lateral glide to the knee, the therapist will position themselves next to the affected knee. They will employ the belt to facilitate the glide by applying force from the opposite side.

Mulligan Mobilization Technique

i. One leg balance- It requires flexing the opposite leg at the knee, hip, and ankle while standing on the affected foot. This position will be hold for one minute (60 seconds), followed by rest for 10 to 20 seconds, then continue this process twice more. Three repetitions of the same exercise will be performed with the unaffected leg after a brief break. ii. Blind advanced one leg balance- The task will resemble one-legged balance, but the participant will be required to close their eyes while executing the routine, and then repeat it two more times. iii. Toe walking- In this activity, the participant will be instructed to walk a 20-meter distance while balancing on their toes with their toes pointing straight ahead. They will then be asked to walk the same distance again, but this time with their toes pointing outward. After a brief rest, the entire procedure will be repeated once more.

Proprioceptive Exercises

• Stretching of the Gastrocnemius and Soleus Muscles * Frequency: 3-5 times per week. * Intensity: Stretch to the point of mild discomfort, not pain. * Time: Hold each stretch for 30 seconds and repeat 3 times on each leg. * Type: Static stretching. Gastrocnemius Stretch: Stand facing a wall with one foot forward (slightly bent) and the other foot back (straight). Press the back heel into the floor and lean forward to feel the stretch in the calf. Soleus Stretch: From the same position, slightly bend the back knee while keeping the heel on the ground to target the lower calf (soleus muscle). • Stretching of the Hamstrings * Frequency: 3-5 times per week. * Intensity: Stretch to a tolerable point of tension without causing pain. * Time: Hold each stretch for 30 seconds and repeat 3 times on each leg. * Type: Static stretching. Seated Hamstring Stretch: Sit on the floor with one leg straight and the other bent.

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to walk without assistive devices for at least 50 feet.

You may not qualify if:

  • Patients have Kellgren and Lawrence \<grade 2 or above grade 3
  • History of knee surgery, knee joint replacement
  • Patients have been administered corticosteroid injections in last six months - - - History of mental illness, autoimmune disorder, neurological or orthopedic conditions affecting the lower limbs
  • Presence of any other conditions that may affect balance or gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Healthcare Center

Karachi, Sindh, 75600, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30100279BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Atif Khan, PhD Scholar

    National Healthcare Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Atif Khan, PhD Scholar

CONTACT

Atif Hussain Hussain

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Total 60 subjects will be selected by simple random sampling and equally divided into 3 groups: Experimental Group A=Proprioceptive exercises group Experimental Group B=Mulligan Mobilization Technique Group Control Group C= Traditional Physical Therapy. The study will follow a pre-test and post-test design, with assessments to be conducted at baseline, immediately after intervention and 10-weeks follow-up. Study will be continued for 10 weeks and a total number of 30 treatment sessions will be given to each patient with 3 sessions per week. Assessment of the patients will be done at the beginning of 1st Session day and at the end of treatment of 30th Session day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 14, 2025

Study Start

March 27, 2025

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Due to ethical considerations and the need to protect participant confidentiality, individual participant data will not be shared. The informed consent obtained from participants does not include permission for data sharing with external researchers.

Locations