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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan Joint mobilization
Trunk stabilization group
Knee strengthening group
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring manual therapy, kinesiotape, Excercise therapies, isometric contraction, muscle strength

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dow University of Health Sciences & Institute of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Mulligan mobilization group

Trunk stabilization group

Knee strengthening group

Arm Description

This study ARM will received Mulligan joint mobilization and concomitant therapies in this group. The following are the brief detail of therapy Mulligan joint mobilization in Non-weight bearing (NWB): Knee strengthening Kinesiotaping

This study ARM will received Trunk stabilization exercises and concomitant therapies in this group. The following are the brief detail of therapy: Trunk stabilization i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge: Iv. lateral step up: Knee strengthening i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise: Kinesiotaping:

This study ARM will received Knee strengthening exercises and concomitant therapies in this group. The following are the brief detail of therapy: Knee strengthening i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise: Kinesio-taping:

Outcomes

Primary Outcome Measures

Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 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.

Secondary Outcome Measures

Visual Analogue Scale
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
Knee injury and Osteoarthritis Outcome Score (KOOS)
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.
6 Minute Walk Test
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.
Stairs Climb Test
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

Full Information

First Posted
September 18, 2019
Last Updated
May 8, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04099017
Brief Title
Mulligan Manual Therapy and Trunk Stabilization Exercises Versus Isometric Knee Strengthening on Knee Osteoarthritis
Official Title
Effectiveness of Mulligan Joint Mobilizations and Trunk Stabilization Exercises Versus Isometric Knee Strengthening in the Management of Knee Osteoarthritis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
manual therapy, kinesiotape, Excercise therapies, isometric contraction, muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
After confirming eligibility, the physiotherapist performing intervention obtained treatment assignment (S.S. Ali). The subject will not be aware of the group allocation and different time slot will be given for the intervention. Another physiotherapist who will not be aware of allocation concealment, record the reading of outcomes at the baseline, after three and six weeks
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mulligan mobilization group
Arm Type
Experimental
Arm Description
This study ARM will received Mulligan joint mobilization and concomitant therapies in this group. The following are the brief detail of therapy Mulligan joint mobilization in Non-weight bearing (NWB): Knee strengthening Kinesiotaping
Arm Title
Trunk stabilization group
Arm Type
Experimental
Arm Description
This study ARM will received Trunk stabilization exercises and concomitant therapies in this group. The following are the brief detail of therapy: Trunk stabilization i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge: Iv. lateral step up: Knee strengthening i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise: Kinesiotaping:
Arm Title
Knee strengthening group
Arm Type
Other
Arm Description
This study ARM will received Knee strengthening exercises and concomitant therapies in this group. The following are the brief detail of therapy: Knee strengthening i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise: Kinesio-taping:
Intervention Type
Other
Intervention Name(s)
Mulligan Joint mobilization
Intervention Description
This study ARM will received Mulligan joint mobilization and concomitant therapies in this group. The following are the brief detail of therapy 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 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 Kinesiotaping:
Intervention Type
Other
Intervention Name(s)
Trunk stabilization group
Intervention Description
This study ARM will received Trunk stabilization exercises and concomitant therapies in this group. The following are the brief detail of therapy: 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: 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: Kinesiotaping:
Intervention Type
Other
Intervention Name(s)
Knee strengthening group
Intervention Description
This study ARM will received Knee strengthening exercises and concomitant therapies in this group. The following are the brief detail of therapy: 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: 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.
Primary Outcome Measure Information:
Title
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Description
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.
Time Frame
baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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
Time Frame
baseline, 3 weeks and 6 weeks
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
baseline, 3 weeks and 6 weeks
Title
6 Minute Walk Test
Description
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.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Stairs Climb Test
Description
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
Time Frame
baseline, 3 weeks and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHAIKH NABI B NAZIR, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences & Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24259931
Citation
Nam CW, Park SI, Yong MS, Kim YM. Effects of the MWM Technique Accompanied by Trunk Stabilization Exercises on Pain and Physical Dysfunctions Caused by Degenerative Osteoarthritis. J Phys Ther Sci. 2013 Sep;25(9):1137-40. doi: 10.1589/jpts.25.1137. Epub 2013 Oct 20.
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Mulligan Manual Therapy and Trunk Stabilization Exercises Versus Isometric Knee Strengthening on Knee Osteoarthritis

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