Mulligan Manual Therapy and Trunk Stabilization Exercises Versus Isometric Knee Strengthening on Knee Osteoarthritis

May 8, 2022 updated by: Shaikh Nabi Bukhsh Nazir, Dow University of Health Sciences

Effectiveness of Mulligan Joint Mobilizations and Trunk Stabilization Exercises Versus Isometric Knee Strengthening in the Management of Knee Osteoarthritis: a Randomized Controlled Trial

Knee joint arthritis posses a serious health problem and caring for an individual with knee osteoarthritis (KOA) produces a great burden on society. Knee joint pain is associated with physical activity while performing various activities of daily living (ADL) in patients with early and severe osteoarthritis (OA). In addition to knee pain, physical function or daily activity is strongly influenced by the severity of Osteoarthritis of the knee. Mulligan joint mobilization with movement provides evident effects on decreasing the pain and restoring the joint biomechanics. Trunk stabilization exercise will improve the stability of trunk which distributes the weight of body evenly on both feets. The aim of this study is to determine the effects of mulligan joint mobilization and trunk stabilization exercise on pain, disability and submaximal exercise performance in KOA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized control trial will be conducted at IPM&R on 60 subjects with knee osteoarthritis and age between 40-60 years. Initial screening of the subjects will be carried out by the referring consultant. Subjects who fulfilled the study criteria will be recruited using computer generated random sampling after explaining the study objective and taken written informed consent. All participants will be evaluated using visual analogue scale, Knee injury and Osteoarthritis Outcome Score and 6-minute walk test for pain severity, functional limitation and submaximal exercise capacity at 1st, 3rd and 6th week. The subjects will be allocated into three groups through computer generated random allocation. Group 1 will receive mulligan mobilization with kinesiotaping and knee strengthening. Group 2 will receive trunk stabilization exercise, knee strengthening and Kinesiotaping. Group 3 will receive knee strengthening along with kinesiotaping. A drop-out rate of 9 will be taken. Recorded data will be entered and analysed using SPSS version 21. Mean and SD will be calculated of quantitative variables like age, pain, knee related function, submaximal exercise capacity and stair climb by using repeated measure ANOVA. For pair wise comparison, post hoc tukey will be applied. Value of equal to or less than 0.05 will be considered significant.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dow university of health sciences & Institute of physical medicine and rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Both gender (female and male) patients
  • Age between 40 - 60
  • Knee osteoarthritis Grade I & II on Kellgren and Lawrence (K/L) criteria
  • Prediagnosed case of knee OA as per the American College of Rheumatology (ACR).

Exclusion Criteria:

  • Known skin allergies
  • Sensory-motor dysfunction of lower extremity
  • Severe joint deformity of lower extremity
  • Post Traumatic Arthritis
  • Constitutional Symptoms (Fever, Malaise, Weight Loss and high blood pressure)
  • Knee Intraarticular injection in past 3 months
  • Acute low back pain
  • History of spinal surgery
  • Subject using assistive devices for ambulation i.e. cane, walkers, sticks
  • Refused to give consent
  • Body Mass Index > 30 kg/m2
  • Received physiotherapy treatment in the past 3 months
  • Visual Analogue Scale <4
  • Patellofemoral joint arthritis will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mulligan mobilization group

This study ARM will received Mulligan joint mobilization and concomitant therapies in this group.

The following are the brief detail of therapy

  1. Mulligan joint mobilization in Non-weight bearing (NWB):
  2. Knee strengthening
  3. Kinesiotaping
Other: Mulligan Joint mobilization

This study ARM will received Mulligan joint mobilization and concomitant therapies in this group.

The following are the brief detail of therapy

  1. Mulligan joint mobilization in Non-weight bearing (NWB) to weight-bearing (WB) 6 -10 Reps and 3 sets/ session.

    Procedural detail:

    Joint mobilization will be performed in sagittal, frontal and transverse direction, following glide will be preferred will depend on patient adherence to the joint mobilization. Mobilization will be progress from NWB to WB according to patient compliance 27

  2. Knee strengthening Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks
  3. Kinesiotaping:
Experimental: Trunk stabilization group

This study ARM will received Trunk stabilization exercises and concomitant therapies in this group.

The following are the brief detail of therapy:

  1. Trunk stabilization i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge:

    Iv. lateral step up:

  2. Knee strengthening i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise:
  3. Kinesiotaping:
Other: Trunk stabilization group

This study ARM will received Trunk stabilization exercises and concomitant therapies in this group.

The following are the brief detail of therapy:

  1. Trunk stabilization Area: Trunk Type of exercise: Stabilization exercise Intensity: 6-8 reps Frequency: 3 sets per session and 30 second duration break between sets

    Procedural detail:

    i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge:

    Iv. lateral step up:

  2. Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks

    Procedural detail:

    i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise:

  3. Kinesiotaping:
Other: Knee strengthening group

This study ARM will received Knee strengthening exercises and concomitant therapies in this group.

The following are the brief detail of therapy:

  1. Knee strengthening i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise:
  2. Kinesio-taping:
Other: Knee strengthening group

This study ARM will received Knee strengthening exercises and concomitant therapies in this group.

The following are the brief detail of therapy:

  1. Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks

    Procedural detail:

    i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise:

  2. Kinesio-taping:

Muscle stretch method will be applied which involves one Y and two I straps: The Y-shaped tape base will be affixed over the top of patella then pulls up his/her knee to its maximum bending capacity then both end of Y strip is placed around the patella ending on the tibial tuberosity. Then reinforcing I-tape will be affixed at the origin and insertion of MCL and LCL. Tape will be change in every session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Time Frame: baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint.

The KOOS contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sport and leisure activities and quality of life. A score of 0 (extreme problems) 100 (smoothly) can be obtained separately for each sub-range.
baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: baseline, 3 weeks and 6 weeks
It measures the subjective of pain ranges from 10-cm lines with defined cut off scores. The correlation between vertical and horizontal orientations of the VAS is 0.99 . Aggregate score ranges for this screening tool starting with 0-10. Scores between 0-4 means mild pain. Scores between 4-7 indicates moderate pain. Scores between 7-10 means severe pain. pain severity will be assessed at rest and during stairs ascending and descending
baseline, 3 weeks and 6 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: baseline, 3 weeks and 6 weeks

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint.

The KOOS contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sport and leisure activities and quality of life. A score of 0 (extreme problems) 100 (smoothly) can be obtained separately for each sub-range.
baseline, 3 weeks and 6 weeks
6 Minute Walk Test
Time Frame: baseline, 3 weeks and 6 weeks
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. Bright colour tapes will be used to mark the 12m walkway at each end. It will be ensured that the environment will be free from hazards and readings will be recorded by blind assessor. Participant will be instructed to wear comfortable shoes.
baseline, 3 weeks and 6 weeks
Stairs Climb Test
Time Frame: baseline, 3 weeks and 6 weeks
Stair climb test is used to measure the total time taken by the participant to ascend and descend stair onto with a step length of 16-cm (ICC=0.90). If safety is of concern, the assessor should guard behind the participant going up the stairs and to the side coming down the stairs. If there is no concern for safety, the tester should remain at the start/finish position on the ground landing
baseline, 3 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: SHAIKH NABI B NAZIR, MSAPT, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

March 20, 2021

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 8, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM&R/DUHS-19/

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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