Whole-Body Vibration in Patients With Patellofemoral Pain Syndrome
ConditionPatellofemoral Pain, PFP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPamukkale University
About this trial
Patellofemoral Pain Syndrome (PFPS), or anterior knee pain, is one of the most common disorders affecting the lower extremities.
Currently, there is no established "gold standard" treatment for PFPS. However, various interventions-including strengthening of the hip and knee muscles (e.g., hip abductors, external rotators, and knee extensors), taping, bracing, foot orthoses, manual therapy, acupuncture, blood flow restriction training, and conventional physical agents (e.g., ultrasound, cryotherapy, neuromuscular electrical stimulation, laser therapy, electromyographic biofeedback, etc.)-have been reported to provide meaningful clinical benefits. Strengthening of the hip and knee muscles alone has been shown to improve both pain and function in the short, medium, and long term. In recent high-quality studies, hip and knee muscle strengthening has been recognized as an effective "classical" treatment approach for PFPS. Regarding the mechanism of pain relief, previous research suggests that strengthening these muscles may alleviate pain by stabilizing patellar motion and/or reducing pressure on the patellofemoral joint.
Similar to traditional resistance training, whole-body vibration (WBV) training is an alternative method for muscle strengthening. WBV platforms can generate vertical vibrations that stimulate tonic vibration reflexes through muscle spindles, thereby activating homonymous alpha motor neurons and inducing reflex muscle contractions. As a result, increased motor unit recruitment enhances the excitability of muscle spindles, leading to improved muscle strength. Additionally, WBV training can improve muscle balance, strength, and function. Therefore, combining WBV with hip and knee strengthening exercises may represent a more effective treatment strategy for PFPS. The aim of this study is to evaluate whether the combination of WBV and hip-knee muscle strengthening is more effective in reducing pain and improving function than hip-knee strengthening alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 40 years,
Diagnosed with unilateral Patellofemoral Pain Syndrome (PFPS),
Ability to understand the procedures, potential benefits, and possible adverse effects,
Willingness to participate in the treatment program.
Disqualifiers
Severe injury or pathological changes in knee structures (e.g., ligaments, menisci, patellar tendons, iliotibial bands, joint capsules, or plicae),
History of significant trauma or surgery involving the knee or lower extremity,
History of patellar dislocation or subluxation,
Diagnosis of Osgood-Schlatter disease or Sinding-Larsen-Johansson syndrome,
Trial design
Design model
Parallel
Treatments tested in this trial
Whole body vibration
DeviceIn this group, prior to the patient stepping onto the platform, the practitioner will turn off the vibration motor of the device and activate an external motor (which is not in contact with the WBV device, has no effective vibration capability, and only produces sound), installed by our team. Since the visual display of the device remains active, patients will not be aware that the actual vibration function is disabled, thereby preventing any bias related to device inactivity.
Sham Whole Body Vibration
DeviceIn this group, prior to the patient stepping onto the platform, the practitioner will turn off the vibration motor of the device and activate an external motor (which is not in contact with the WBV device, has no effective vibration capability, and only produces sound), installed by our team. Since the visual display of the device remains active, patients will not be aware that the actual vibration function is disabled, thereby preventing any bias related to device inactivity.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
VAS
Pain is the most characteristic symptom in Patellofemoral Pain Syndrome (PFPS). After recording the duration of pain (in months) for each patient, pain intensity was assessed using the Visual Analog Scale (VAS), which is a 10-centimeter (cm) line anchored by 0 (no pain) and 10 (unbearable pain). Patients were asked to rate their pain at rest, during stair ascent/descent, squatting, prolonged sitting, and walking. Crossley et al. have reported that the VAS is a valid, reliable, and responsive tool for assessing pain in individuals with PFPS
Time frame
Change from baseline VAS at the 8th week after the treatmentSecondary outcomes
1
Anterior Knee Pain Scale
Subjective symptoms and functional limitations of patients with Patellofemoral Pain Syndrome (PFPS) were evaluated using the Kujala Patellofemoral Scoring System. This scoring system was developed by Kujala et al. in 1993, and it allows for functional assessment of knee pathologies related to the patellofemoral structure. The Kujala Patellofemoral Pain Score consists of 13 subcategories evaluating limping, weight bearing, walking, stair activities, squatting, jumping, prolonged sitting with knees flexed at 90°, running, pain, swelling, abnormal painful patellar movement, thigh atrophy, and loss of flexion. The total score ranges from 0 to 100 points, with 100 indicating the best functional status.
Time frame
Change from baseline AKPS score at the 8th week after the treatment2
Short Form - 36
The quality of life of all patients will be assessed using the Short Form-36 Health Survey (SF-36). This instrument consists of 36 items and measures eight health domains: Physical functioning (10 items), Social functioning (2 items), Role limitations due to physical problems (4 items), Role limitations due to emotional problems (3 items), Mental health (5 items), Energy/vitality (4 items), Bodily pain (2 items), and General health perception (5 items)
Time frame
Change from baseline SF-36 score at the 8th week after the treatment3
Muscle Mass Assessment via Ultrasound
Muscle mass measurements of the vastus medialis and gluteus medius muscles will be performed using ultrasound (Clarius™ by Clarius Mobile Health) both before and after treatment. For the vastus medialis, the patient will be positioned supine with the knee in approximately 30 degrees of flexion. The ultrasound probe will be placed on the medial quadriceps region, between the medial border of the patella and the medial femoral condyle. The probe will be angled at approximately 45° to the long axis of the femur, oriented parallel to the muscle fibers. For the gluteus medius, the patient will be positioned in side-lying, with the painful side facing upward. The probe will be placed at the lower half of the distance between a line connecting the anterior superior iliac spine (ASIS) and the posterior superior iliac spine (PSIS) and the greater trochanter. Measurements will be performed by the same evaluator at baseline and at the 8th week following treatment.
Time frame
Change from baseline muscle mass assessment at the 8th week after the treatment4
Change in peak torque at 60°/s (Nm) of the knee muscles measured by isokinetic dynamometer
Isokinetic assessment of the symptomatic (painful) knee will be performed using the IsoMed 2000 Isokinetic System. Participants will be seated in an upright position with stabilization of the trunk and lower limbs. Peak Torque (PT, measured in Newton-meters, Nm) represents the maximum torque generated during knee flexion and extension at an angular velocity of 60°/s. Participants will perform four maximal repetitions following three familiarization trials. The change in PT from baseline to week 8 will be used to assess improvement in knee muscle endurance at higher movement speeds.
Time frame
Change from baseline to Week 8 after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: