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

NCT ID: NCT04099017

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2021-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Mulligan Joint mobilization

Intervention Type OTHER

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:

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:

Group Type EXPERIMENTAL

Trunk stabilization group

Intervention Type OTHER

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:

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:

Group Type OTHER

Knee strengthening group

Intervention Type 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 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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:

Intervention Type 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:

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shaikh Nabi Bukhsh Nazir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SHAIKH NABI B NAZIR, MSAPT

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Karachi, Sindh, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24259931 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38715135 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IPM&R/DUHS-19/

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.