NCT04099017

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

September 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

September 18, 2019

Last Update Submit

May 8, 2022

Conditions

Keywords

manual therapykinesiotapeExcercise therapiesisometric contractionmuscle strength

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training

Secondary Outcomes (4)

  • Visual Analogue Scale

    baseline, 3 weeks and 6 weeks

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    baseline, 3 weeks and 6 weeks

  • 6 Minute Walk Test

    baseline, 3 weeks and 6 weeks

  • Stairs Climb Test

    baseline, 3 weeks and 6 weeks

Study Arms (3)

Mulligan mobilization group

EXPERIMENTAL

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

Trunk stabilization group

EXPERIMENTAL

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

Knee strengthening group

OTHER

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

Interventions

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:

Mulligan mobilization 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:

Trunk stabilization 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.

Knee strengthening group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 24259931BACKGROUND
  • Nazir SNB, Rathore FA. Efficacy of Mulligan joint mobilizations and trunk stabilization exercises versus isometric knee strengthening in the management of knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 May 7;16(1):105. doi: 10.1186/s13102-024-00893-7.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • SHAIKH NABI B NAZIR, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

September 20, 2020

Primary Completion

February 24, 2021

Study Completion

March 20, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 3 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations