Design
This quadruple blinded, parallel arm, randomized controlled trial included 2 evaluation sessions (baseline, and post-treatment) and a six-week intervention (traditional knee rehabilitation program, or proximal stabilization added to the traditional program). The outcome measures were the kinesiophobia quantified using Tampa scale, and recruitment strategies of vasti, GM, TrA, and multifidus during stair descent measured by surface electromyography.
Participants
Of 153 females screened from Outpatient clinics of Kasr Alainy Medical School at Cairo University, the study's inclusion criteria were not met by 103 females; thus, they were excluded from participating in the trial while the study's details and objectives were explained to the fifty volunteers who met the criteria, and they consented to participate. After obtaining their written consent, they were randomized in a 1:1 ratio into one of two equal treatment groups; traditional knee rehabilitation group (the control group A) or proximal stabilization added to the traditional program (the experimental group B) by the physical therapist responsible for applying the allocated treatments through lottery. To do that, fifty pieces of paper were put into a box; half of them were labeled as (A) and the other half were labeled as (B). Each patient was asked to pick one piece of paper to know which group she would be assigned to. The enrolled participants were omitted from knowing whether the group to which they were randomized was the experimental or the control. This allocation was also concealed from the researchers involved in collecting data from patients pre and post treatment, Matlab analysis, and statistical analysis which made this trial a quadruple blinded trial.
Before undertaking this trial, ethical approval (No. P.T.REC/012/003438) was acquired from the Institutional Review Board of the Faculty of Physical Therapy of Cairo University, then it was registered prospectively (NCT05597670) at clinicaltrials.gov. The study was carried out between November 2022 and June 2024.
Eligibility Criteria
Females between 35 and 55 years old (25) with PF OA and body mass index below 32 were included if they experienced anterior or retro-patellar knee pain on most days during the previous month and rated at least four and over on the eleven-point numerical rating scale (NRS) during at least 2 activities that load the PFJ including stair negotiation, rising from a chair, and squatting (26). According to the Kellgren-Lawrence OA grading system, patients must have radiographic signs of PF osteoarthritis with a grade of less than 2 from the postero-anterior views to exclude any concomitant tibiofemoral arthritis (27).
Exclusion criteria included people who exercised more than 2 hours per day or every other day, those who experienced at least a three-month pain in lumbar spine, foot, or hip that needed treatment, those with a history of fractures or surgeries in lower limbs, spine, pelvis, hip, knee, or foot, those with a hip or patellar subluxation or dislocation, those with an injury to the meniscus or any of the supporting knee ligaments, those with fibromyalgia, or neurological conditions (8).
Assessment
All participants' baseline demographic data, including age, duration of illness, and body mass index (BMI), were collected before the EMG measurements.
Outcome Measures
The following variables were collected from all patients:
-
Kinesiophobia measured by the Arabic version of Tampa scale (28) which includes seventeen questions (29) and the response for each question ranges from 1 which is equivalent to strongly disagree to 4 which is equivalent to strongly agree and in order to calculate the overall score, the responses are combined together (24). The overall score ranges from 17 to 68 with 17, and 68 inferring no kinesiophobia, and severe kinesiophobia, respectively (24).
-
The recruitment strategies (onset and duration) of vasti, GM, TrA, and multifidus during stair descent. First, the activation of these muscles was measured using an eight-channel, high resolution wireless bio amplifier (WBA) surface electromyography from Biomation in Almonte, Canada. The recorded EMG data were sampled at 1000 Hz and an EMG amplifier (band-pass filtered between 50 and 200 Hz) was adjusted to optimize signal resolution. Thereafter, the sampled amplified data were stored in a personal laptop to detect the activation onset and duration by Matlab analysis.
Procedures For EMG Measurement and analysis
The subject's skin was cleansed with alcohol prior to the electrode implantation to lower impedance, and extra hair was shaved to prevent sliding of the electrodes if necessary. Three disposable bipolar Ag-AgCl surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) were applied to each muscle; two electrodes were spaced roughly 30 mm apart in the direction of the muscle fibres (30), and the third electrode was applied over the nearest bony prominence as a ground electrode. Electrodes were installed for the multifidus muscle 2 cm laterally to the L5 spinous process (30, 31), whereas the electrodes were positioned 2 cm medial and inferior to anterior superior iliac spine for TrA, but this electrode placement to assess the transversus abdominus also depicts the activity of the internal obliques (IOs), because the two muscles cannot be distinguished functionally or anatomically using the surface EMG approach (32). Electrodes were positioned over the GM's muscle belly at a distance of one-third between both the iliac crest and greater trochanter (30). Approximately 5 cm medial to a location that is 25% of the distance between the superior portion of the patella to the anterior superior iliac spine is where electrodes for the vastus medialis obliques (VMO) were placed, while the electrodes were placed for the vastus lateralis (VL) lateral to the rectus femoris, midway between the lateral femoral epicondyle and greater trochanter (33).
The patients were instructed to descend 2 steps without handrails (each step measured 20 cm in height and 40 cm in breadth. First and second stairs were 30 cm and 40 cm deep, respectively) with their most painful limb (34) at their normal speed (35, 36) in response to a command barefooted with one foot on each step and they should keep their arms by their side all over the task. Each patient was instructed to perform one practice attempt of stair descent to be familiar with the test procedures before starting the actual data collection, then for data acquisition, each patient performed three attempts of the task they already became accustomed with, and they were given a break of thirty seconds after each attempt to avoid fatigue. The mean value of the data in the three attempts was used in further analysis.
All EMG data were processed by a custom software in Matlab (Math Works, Natick, Massachusetts, USA). For that, data were full wave rectified, then high-pass filtered using a fourth-order Butterworth filter (75 KHz). A computer algorithm was used to determine the onset and cessation of the EMG activity. Three hundred milliseconds before the beginning of each attempt were used to identify the baseline activation of muscles in standing. The point at which the EMG signal surpassed (for onset) or dropped below (for cessation) 3 standard deviations (SDs) of baseline for a minimum of 25 milliseconds was determined to be the threshold for muscle activity onset and cessation (37), then the duration of muscular activity was identified as the time from activation onset to cessation (38).
Treatment regime implemented for both groups.
Females in both groups whether the control or the experimental group received a multimodal regime in the form of exercises to stretch the calf, quadriceps, and hamstrings, transcutaneous electrical nerve stimulation (TENS) using two adhesive electrodes applied around the painful patella, not to mention clamshell exercise and mini squat used to strengthen muscles around hip and knee (39). The physical therapist responsible for applying the treatment regime (J.A.) used a universal goniometer to restrict patients from flexing their knees beyond 45o while performing the mini squat exercise. Moreover, to execute the progressive resistance concept while performing the mini squat and clamshell exercises, the ten-repetition maximum was measured at fixed time intervals for each individual patient; the first, the 5th, and the 9th treatment sessions using color code elastic bands. The exercise was executed for a total of three sets of ten repetitions, with a one-minute rest interval between sets.
Protocol implemented to boost core stability.
Females randomly assigned to the experimental group received additional exercises that focused on activating the transversus abdominus, multifidus, and the abdominal oblique muscles to boost core stability. we substituted a more intense exercise for a less intense one according to the ability of the subject to hold and repeat the less intense exercise for a definite number of times.
Exercises that focused primarily on activating TrA arranged from the less intense to the more intense are 8-seconds hold abdominal drawing in maneuver repeated 30 times, 4-seconds hold abdominal drawing in maneuver with heel slide repeated 20 times for each leg, 4-seconds hold abdominal drawing in maneuver with leg lifts repeated 20 times for each leg, 8-seconds hold abdominal drawing in maneuver with bridging repeated 30 times, 6-seconds hold standing abdominal drawing in maneuver with row exercise repeated 30 times, and abdominal drawing in maneuver while walking (40).
Exercises that focused primarily on activating multifidus arranged from the less intense to the more intense are 8-seconds hold abdominal drawing in maneuver with quadruped arm lifts repeated 30 times on each side, 8-seconds hold abdominal drawing in maneuver with quadruped leg lifts repeated 30 times on each side, and 8-seconds hold abdominal drawing in maneuver with quadruped contralateral arm and leg lifts repeated 30 times on each side (40).
Exercises that focused primarily on activating abdominal oblique muscles arranged from the less intense to the more intense are 8-seconds hold abdominal drawing in maneuver with flexed knees-side plank repeated 30 times on each side, and 8-seconds hold abdominal drawing in maneuver with extended knees-side plank repeated 30 times on each side (40).
Statistical Analysis
A pilot study was conducted, including five participants in each group to predict the size of the needed sample. The sample size for this study was calculated using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany). Sample size calculation based on F tests (MANOVA: Global effects), Type I error (α) = 0.05, power (1-α error probability) = 0.90, and effect size f2 (V) = 0.92 with 2 independent groups comparison for 11 major variable outcomes. The appropriate minimum sample size for this study was 36 participants (18 participants in each group as a minimum).
Statistical analysis for all reported data was performed using the 23-version of SPSS (Statistical Package for Social Sciences) for windows (SPSS, Inc., Chicago, IL). The EMG onset and duration of the VL, VMO, TrA, gluteus Medius, and multifidus muscles during stair descent, and kinesiophobia were among the eleven dependent variables in this study, while two independent variables were involved; The first one was the tested group which had two levels (Control group A received a traditional therapeutic knee rehabilitation program and experimental group B received additional proximal stabilization exercises) and the second one was the measuring periods which had two levels (pre-treatment, post-treatment). The 2x2 mixed design MANOVA (multivariate analysis of variance) was performed to compare the mean values of the 11 independent variables between patients in the control group and study group. The baseline demographic and clinical characteristics (age, duration of illness, and BMI) between patients in the control and study groups were compared using an independent t-test. The statistically significant level was defined as p < 0.05.