Clinical trial NCT04099017: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: manual therapy
kinesiotape
Excercise therapies
isometric contraction
muscle strength
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
timeFrame: baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline, 3 weeks and 6 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline, 3 weeks and 6 weeks
measure: 6 Minute Walk Test
timeFrame: baseline, 3 weeks and 6 weeks
measure: Stairs Climb Test
timeFrame: baseline, 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences & Institute of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: SHAIKH NABI B NAZIR, MSAPT
role: PRINCIPAL_INVESTIGATOR
References:
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.