In this randomized controlled clinical trial, all patients diagnosed with PFPS admitted to the Emam Reza hospital in Tehran (Iran) between 2017 and 2019 were included. After receiving the study approval by the Institutional Review Board at the AJA University of Medical Sciences and obtaining written informed consent from all participants, eligible patients were divided into two groups of study or control. Data were collected using a checklist and questionnaire. The inclusion criterion was referring to the physical medicine and rehabilitation clinics of the Emam Reza Hospital with PFPS diagnosis. Exclusion criteria were being diagnosed with radiculopathy, tibiofemoral degenerative joint diseases (grade 2 and above based on the Kellgren-Lawrence radiographic grading), existing pes planus, and history of lumbar disc herniation, surgery, and knee trauma. The eligible patients were divided into two groups, each with 15 subjects. The study group received the lumbosacral manipulation with the knee exercises, and the control group received the knee exercises alone.
Radiographic examinations, including anterior-posterior, lateral, and patellar views of the knee, were performed for all participants at the beginning of the study. Anterior-posterior and lateral views of the lumbosacral were also obtained for all participants.
All individuals in the study group received a single bilateral lumbosacral manipulation after ruling out any contraindication for lumbosacral manipulation by lumbosacral radiography. The manual movements were performed by a trained professional at the level of L2 to S1 (the quadriceps and hamstrings muscles’ neuronal levels). Then, both groups participated in the therapeutic strengthening knee exercise program (included the straight leg raise, quadriceps isometric, cuff, and hamstring stretching exercises) for 4 weeks (twice a day, every day of the week). It should be noted that individuals were not allowed to perform activities that could trigger knee pain during the program. All exercise techniques were based on Therapeutic Exercise, Foundations, and Techniques by Carolyn Kinser (
22).
Gait analysis (including cadence, foot pressure, single support time, and double support time), measuring the range of motion of the knee, assessment of quadriceps muscle strength by superficial electromyography, Visual Analog Scale (VAS), and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires were used to collect information before providing the interventions, during the second session, and four weeks after knee strengthening exercises.
To assess improvement in pain severity, VAS was used in two measurement sessions (
23). To assess the knee pain, symptoms, function in daily living, function in sport and recreation, and knee-related quality of life, the KOOS worldwide questionnaire was completed in two measurement sessions by all participants. The KOOS includes 42 patient-centered items on five patient-related subscales: Pain (9 items), symptoms (stiffness, etc.) related to the disease (7 items), daily activities (climbing the stairs, standing, etc.) (17 items), sports and recreational activities (jumping and running) (5 items), and knee-related QoL (4 items). Each item has five possible answers on a Likert scale. The score of each subscale ranges from zero to 4. Therefore, the total score of KOOS ranges from zero (“No Problems”) to 100 (Extreme Problems) (
24).
The Kellgren-Lawrence radiographic grading system uses radiological evidence of osteophytes presence and reduction of articular space to categorize patients into five groups based on the severity of the pain, as follows: grade 0 (none); grade 1 (doubtful narrowing of the joint space with possible osteophyte formation); grade 2 (possible narrowing of the joint space with definite osteophyte formation); grade 3 (definite narrowing of joint space, moderate osteophyte formation, some sclerosis, and possible deformity of bony ends); grade 4 (osteophyte formation, severe narrowing of the joint space with marked sclerosis, and definite deformity of the bone end) (
25). Most of the recent osteoarthritis-related studies have used this grading system to diagnose osteoarthritis or to determine the severity of joint involvement.
3.1. Data Analysis
Data analysis was performed using SPSS version 24. Quantitative data are described using mean and standard deviation. While frequency was used to describe qualitative data. The Kolmogorov-Smirnov test was applied to test for a normal distribution. Quantitative variables were analyzed using t-test and ANOVA. Categorical variables were compared using the Chi-square test. Statistical significance was considered when P value < 0.05.