Study design
The three-arm randomized controlled trial will be carried out at the Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences. This study has been approved by the Institutional Review Board (IRB), Dow University of Health Sciences (IRB-1433/DUHS/Approval/2019/118). The randomized controlled study will follow SPIRIT, CONSORT and Tidier guidelines.
Study population and allocation
A physiatrist and an orthopedic surgeon will perform clinical examinations of participants and evaluate x-rays taken within a three month period. Those participants who fulfil the inclusion criteria will be selected from the Outpatient Department of the Institute of Physical Medicine and Rehabilitation at Dow University of Health Sciences and the Orthopaedic Department of the Civil Hospital, both in Karachi. All patients will participate voluntarily and be required to sign an informed consent form after receiving oral and written explanations of the purpose of the study and the procedures to be used.
Inclusion criteria
- Men and women aged 40 – 60 years.
- Knee osteoarthritis Grade I and II based on Kellgren and Lawrence (K/L) radiological criteria.22
- Confirmed diagnosis of KOA based on the clinical criteria of ACR.23
- Use of medicines such as vitamin D and calcium supplements
Exclusion criteria
- Known skin allergies to Kinesiotaping
- 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)
- lower back pain
- History of spinal surgery
- Using assistive devices for ambulation, i.e. cane, walkers, sticks
- Receipt of physiotherapy treatment in the past three months
- Visual Analogue Scale <4
- Patello-femoral joint arthritis
Randomization and allocation concealment
The study subjects will be randomly assigned to one of three groups (ratio 1:1:1) using a research randomizer (www.random.org). The schedule will be concealed using sequentially numbered opaque, sealed envelopes. The envelopes will be stored in a locker and opened in sequence within each stratum to reveal group allocation.
Masking
After confirming the eligibility of the subjects, a physiotherapist will perform interventions for each group after obtaining treatment assignment from S.S. Ali. The subjects will not be aware of the group to which they are assigned, and different time slots will be given for each intervention. Another physiotherapist who will also not be aware of allocation concealment, will record the reading of outcomes at the baseline, after three and six weeks.
Interventions
The intervention frequency will be four sessions a week on alternate days for 6 weeks, i.e. 24 sessions in all. Figure 1 shows the flow diagram of the trial. 42
Source: Schulz KF, Altman DG, Moher D; for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med 2010;4(1):60-68.
Mulligan joint mobilization
Area: Knee Joint
Mobilization: Non-weight bearing (NWB) to weight-bearing (WB)
Intensity: 6–10 reps
Frequency: 3 sets/ session
Procedural detail:
Joint mobilization will be performed in the sagittal, frontal and transverse direction, glide given will depending on patient adherence to joint mobilization. Mobilization will progress from NWB to WB, according to the compliance of the patient. 24
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:
- Participants will start in the prone position on the bed. They will raise and lower their legs without flexing knees. The lumber region will be stabilized during this exercise to prevent the arms from moving.
- Back bridge:
The participant will lie supine on the bed with knees flexed at 90 degrees, and lift the pelvis to align the spine and thighs.
3. Unilateral back bridge:
In back-bridge position with the pelvis lifted and a neutral spine position, extend one knee by lifting the foot off the ground.
4. lateral step up:
Standing at the side of a 10-cm step, step up sideways onto to the step. 25
Knee Strengthening
Area: Knee Joint
Type of exercise: Knee Isometric Strengthening exercises.
Load: maximum isometric contraction
Intensity: 10 reps
Frequency: Beginning with one set of all knee exercises then increasing to two sets at three weeks, and three sets for the remainder of sessions.
Procedural detail:
- Isometric quadriceps exercise: The patient will lie supine on the bed. A rolled-up towel will be placed under the knee. They will be instructed to press the knee on the towel to maximally activate the quadriceps isometrically. The participant will hold this position for 5 seconds.
- Straight leg raising (SLR) exercise: The participant will lie supine on the bed They will be instructed to perform a maximum isometric quadriceps contraction prior to the lifting phase of the exercise. Then they will be instructed to lift the leg up to 10 cm above the plinth and hold the contraction during the lifting phase for 10 seconds. 26-27
Kinesio-taping
The muscle-stretch method will use one Y and two I straps: The Y-shaped strap will be fixed over the top of patella, and the knee will be bent as far as possible before both ends of Y strip are placed around the patella ending on the tibial tuberosity. Reinforcing I-tape will be fixed at the origin and insertion of MCL and LCL, and changed after every session. 28
Measurement of outcomes
In patients with unilateral osteoarthritis, only the affected knee will be examined throughout the study. For patients with bilateral KOA, the most painful knee will be studied. 29
Visual Analogue Scale
This measure subjective pain ranges in 10-cm intervals with defined cut-off scores.30 It will be measured at rest and while the patient is ascending and descending stairs. A baseline reading will be taken at the beginning of the study for comparison with further readings at 3rd week and 6th week
Knee injury and Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome measure intended for use by middle-aged and elderly patients with knee osteoarthritis (OA) to monitor disease course and outcomes during interventions. KOOS has five subscales and their reliability (1) Pain (r=0.93) (2) other Symptoms (r=0.85) (3) Activities of Daily Living (r=0.95) (4) Sport and Recreation function (r=0.75) and (5) knee-related Quality of Life (r=0.79). 31 Each subscale generates a final score ranging from 0 to 100, where 0 represents “worst” and 100 “best”.32
6-Minute Walk Test
The 6-Min Walk Test (6 MWT) is a test of sub-maximal exercise that entails measuring distance walked over a span of six minutes. Bright-coloured tapes will be used to mark each end of the 12 m walkway. The environment will be free of hazards and readings will be recorded by a assessor who has no knowledge of the group to which the patient belongs. Patients will be instructed to wear comfortable shoes. 33
Stairs Climb Test
The Stair Climb Test is used to measure the total time taken by the participant to ascend and descend a set of stairs with a step height of 16 cm (ICC=0.90). If safety is of concern, the assessor will walk behind the participant going up the stairs and at the side while going down the stairs. If there is no concern for safety, the tester will remain at the start/finish position on the ground landing. 34
Rescue medicine
Any use of paracetamol will be ascertained at weeks 3 and 6 after randomization.
Adverse effects
There have been no significant risks and no side effects recorded with this treatment intervention apart from a temporary increase in pain, fatigue, muscular strain and skin irritation. In the case of any related event, application of cryotherapy and rest will be considered.
Data management
The subject will be identified by a serial number rather than by his/her name to ensure total anonymity at all times. All identification will be removed from the data for individual participants before collection. although the principal researcher will have access to participants' personal data. After completing this study, data will remain the property of the Dow University of Health Sciences. Data will be stored from three months and to three years after article publication.
Sample size
The sample size was calculated using PASS software. In the pain section, Group1 2.23+0.73, Group2 3.12+0.66, Group3 3.98+0.73 we used this difference to calculate the sample size. We included a power of 99%, confidence interval of 99% and a sample size of 11 per group by using one-way ANOVA. To manage the dropout rate, the sample size is set at 20 per group. 35
Statistical analysis
Data will be entered and analyzed using SPSS version 23. Comparison of group demographics will be conducted using the One-Way Anova analysis for continuous variables, in this case, age, Body Mass Index and duration of symptoms. Chi-square analysis will be used to compare groups using category data such as gender and K/L criteria. Mean and SD will be calculated for quantitative variables such as pain, knee function, sub-maximal exercise capacity and stair climbing using repeated-measure ANOVA. For pairwise comparison, post hoc Tukey will be applied. A value of less than 0.05 will be considered significant. Analysis of Intention to treat will also be carried out in this research.