"Effectiveness of Mulligan Mobilization Technique and Proprioceptive Exercises Among Patients With Knee Osteoarthritis"

Official title

"Effectiveness of Mulligan Mobilization Technique and Proprioceptive Exercises Among Patients With Knee Osteoarthritis in Karachi" The Study 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 Device for at Least 50 Feet

Overview

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.

Detailed description

The research examines the effectiveness comparison between Mulligan Mobilization Technique and Proprioceptive Exercises for knee OA patients by adopting the following illustrated conceptual framework.

The study's independent variable consists of both Mulligan Mobilization Technique and Proprioceptive Exercises as treatment interventions. The evaluation tools include Numeric Pain Rating Scale (NPRS), Universal Goniometer, Knee Injury and OA Outcome Score (KOOS), Berg Balance Scale (BBS) and Quality of Life Short Form (SF-36) for assessing pain, range of motion, functional status, balance and quality of life respectively.

The research's experiment expects the independent treatment to modify the analyzed outcomes. The pre-test and post-test experimental setup will assess how well the intervention treatments affect the dependent variables. Two treatments known as Mulligan Mobilization Technique with Proprioceptive Exercises will be assessed for their effectiveness in treating knee OA patients throughout the study. The study will evaluate the effect of age together with gender and body mass index (BMI) as well as disease severity on outcomes from different interventions.

CONSENT FORM (ENGLISH) Title of Study: Effectiveness of Mulligan Mobilization Technique and Proprioceptive Exercises among Patients with Knee Osteoarthritis in Karachi

Introduction: You are being invited to participate in a research study. Please read this form carefully and feel free to ask any questions you may have before agreeing to participate.

Purpose of the Study: The purpose of this study is to compare the effectiveness of Mulligan Mobilization Technique versus Proprioceptive Exercises on pain, range of motion, functional status, balance and quality of life among patients with knee OA.

Procedures: If you agree to participate in this study, you will be asked to complete a series of questionnaires to evaluate your pain, range of motion, functional status, balance and quality of life. You will also receive either Mulligan Mobilization Technique, Proprioceptive Exercises or Traditional Physical Therapy depending on the group you are randomly assigned to Mulligan Mobilization Technique is a manual therapy technique that aims to improve joint mobility and reduce pain. Proprioceptive Exercises are exercises that focus on improving balance and joint position sense. The treatment will be performed by a licensed physical therapist who has been trained to perform both techniques. You will receive 30 sessions of treatment over a period of ten weeks. Each session will last approximately 45 minutes.

Risks and Benefits: There are no anticipated risks associated with participating in this study. However, some participants may experience temporary pain or discomfort during the treatment sessions. The benefits of participating in this study include the potential to improve pain, range of motion, functional status, balance and quality of life among patients with knee OA. Participants are requested not to perform other treatment or take any painkillers during the period of intervention and evaluation.

Confidentiality: Your participation in this study will be kept confidential. Your personal information will be kept in a secure location and will only be accessible to the researchers involved in the study.

Voluntary Participation: Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without any penalty.

Contact Information: If you have any questions or concerns about the study, please feel free to contact Muhammad Atif Khan (Principal Investigator) at 0092-332-2281028 or mak\_physio@yahoo.com.

Consent: By signing below, you acknowledge that you have read and understood the information provided in this form, and you voluntarily agree to participate in the study.

Participant Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Researcher Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Interventions

• Other Mulligan Mobilization technique
  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 me
• Other Proprioceptive Exercises
  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
• Other Traditional Physical therapy
  • 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, slight

Primary outcome measures

• Knee Injury and Osteoarthritis Outcome Score [Time frame: 10 weeks]
• Universal Goniometer [Time frame: 10 weeks]
• Numeric Pain Rating Scale (NPRS) [Time frame: 10 weeks]
• Berg Balance Scale (BBS) [Time frame: 10 weeks]

Secondary outcome measures (1)

• Quality of Life Short Form (SF-36) [Time frame: 10 weeks]

Eligibility criteria

Inclusion criteria

• Inclusion criteria will include diagnosed cases of knee OA with mild to moderate Grade of OA (According to Kellgren and Lawrence Scale)
• Ability to walk without assistive devices for at least 50 feet.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• National Healthcare Center — Karachi

Publications

• 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 30100279

Identifiers

NCT: NCT06971016 · LUC/MKT/IND/SP/03/327 · Lincoln University College

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗