NCT07382037

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

August 9, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

February 2, 2026

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 9, 2025

Last Update Submit

January 25, 2026

Conditions

Keywords

whole body vibrationknee

Outcome Measures

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

    Change from baseline VAS at the 8th week after the treatment

Secondary Outcomes (9)

  • Anterior Knee Pain Scale

    Change from baseline AKPS score at the 8th week after the treatment

  • Short Form - 36

    Change from baseline SF-36 score at the 8th week after the treatment

  • Muscle Mass Assessment via Ultrasound

    Change from baseline muscle mass assessment at the 8th week after the treatment

  • Change in peak torque at 60°/s (Nm) of the knee muscles measured by isokinetic dynamometer

    Change from baseline to Week 8 after treatment

  • Change in peak torque at 240°/s (Nm) of the knee muscles measured by isokinetic dynamometer

    Change from baseline to Week 8 after treatment

  • +4 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Whole body vibration group, 3 days a week, 30 minutes a day for 8 weeks

Device: Whole body vibration

Sham group

SHAM COMPARATOR

Sham-whole body vibration, 3 days a week, 30 minutes a day for 8 weeks

Device: Sham Whole Body Vibration

Interventions

In 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.

Experimental

In 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 group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years,
  • Diagnosed with unilateral Patellofemoral Pain Syndrome (PFPS),
  • Reporting anterior knee pain or pain behind the patella in at least two of the following activities:
  • ascending stairs, jumping, running, squatting, kneeling, prolonged sitting,
  • \- Positive results in at least two of the following clinical tests: Eccentric step-down test, Patellar border tenderness test, Patellar grind (Clarke's) or apprehension test,
  • Ability to understand the procedures, potential benefits, and possible adverse effects,
  • Willingness to participate in the treatment program.

You may not qualify if:

  • 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,
  • Joint effusion in the knee, or presence of redness, swelling, or increased warmth on physical examination,
  • Serious systemic conditions, including cardiovascular diseases, tumors, gallstones or kidney stones, severe disc or spinal lesions, pacemaker implantation, epilepsy, recent fractures or surgeries, or acute arthritis,
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20160, Turkey (Türkiye)

Location

Related Publications (15)

  • Dag F, Dal U, Altinkaya Z, Erdogan AT, Ozdemir E, Yildirim DD, Colak M. Alterations in energy consumption and plantar pressure distribution during walking in young adults with patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2019 Jan;53(1):50-55. doi: 10.1016/j.aott.2018.10.006. Epub 2018 Oct 25.

    PMID: 30482589BACKGROUND
  • Corum M, Basoglu C, Yakal S, Sahinkaya T, Aksoy C. Effects of whole body vibration training on isokinetic muscular performance, pain, function, and quality of life in female patients with patellofemoral pain: a randomized controlled trial. J Musculoskelet Neuronal Interact. 2018 Dec 1;18(4):473-484.

    PMID: 30511951BACKGROUND
  • Dieterich AV, Pickard CM, Strauss GR, Deshon LE, Gibson W, McKay J. Muscle thickness measurements to estimate gluteus medius and minimus activity levels. Man Ther. 2014 Oct;19(5):453-60. doi: 10.1016/j.math.2014.04.014. Epub 2014 May 10.

    PMID: 24880207BACKGROUND
  • Dogan A, Sengul I, Askin A, Tosun A. Effect of static knee joint flexion on vastus medialis obliquus fiber angle in patellofemoral pain syndrome: An ultrasonographic study. PM R. 2022 Jul;14(7):802-810. doi: 10.1002/pmrj.12655. Epub 2021 Jul 23.

    PMID: 34165244BACKGROUND
  • Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6. doi: 10.3944/AOTT.2010.2252.

    PMID: 20676018BACKGROUND
  • Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.

    PMID: 8461073BACKGROUND
  • Takanashi Y, Chinen Y, Hatakeyama S. Whole-body vibration training improves the balance ability and leg strength of athletic throwers. J Sports Med Phys Fitness. 2019 Jul;59(7):1110-1118. doi: 10.23736/S0022-4707.18.09012-6. Epub 2018 Oct 10.

    PMID: 30317837BACKGROUND
  • Alam MM, Khan AA, Farooq M. Effect of whole-body vibration on neuromuscular performance: A literature review. Work. 2018;59(4):571-583. doi: 10.3233/WOR-182699.

    PMID: 29733043BACKGROUND
  • Petersen W, Rembitzki I, Liebau C. Patellofemoral pain in athletes. Open Access J Sports Med. 2017 Jun 12;8:143-154. doi: 10.2147/OAJSM.S133406. eCollection 2017.

    PMID: 28652829BACKGROUND
  • Crossley KM, Callaghan MJ, van Linschoten R. Patellofemoral pain. Br J Sports Med. 2016 Feb;50(4):247-50. doi: 10.1136/bjsports-2015-h3939rep.

    PMID: 26834209BACKGROUND
  • Ho KY, Keyak JH, Powers CM. Comparison of patella bone strain between females with and without patellofemoral pain: a finite element analysis study. J Biomech. 2014 Jan 3;47(1):230-6. doi: 10.1016/j.jbiomech.2013.09.010. Epub 2013 Oct 15.

    PMID: 24188973BACKGROUND
  • Cheung RT, Zhang Z, Ngai SP. Different relationships between the level of patellofemoral pain and quality of life in professional and amateur athletes. PM R. 2013 Jul;5(7):568-72. doi: 10.1016/j.pmrj.2012.12.007. Epub 2013 Jan 29.

    PMID: 23375635BACKGROUND
  • Smith BE, Selfe J, Thacker D, et al. Incidence and prevalence of patellofemoral pain: a systematic review and meta-analysis. PLoS One. 2018;13(1):e0190892.

    BACKGROUND
  • Dey P, Callaghan M, Cook N, et al. A questionnaire to identify patellofemoral pain in the community: an exploration of measurement properties. BMC Musculoskelet Disord. 2016;17:237.

    BACKGROUND
  • Willy RW, Hoglund LT, Barton CJ, Bolgla LA, Scalzitti DA, Logerstedt DS, et al. Patellofemoral pain: clinical practice guidelines linked to the International Classification of Functioning, Disability and Health from the Academy of Orthopaedic Physical Therapy of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2019;49(9):CPG1-CPG95.

    BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Hakan Alkan, Prof Dr

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Hakan Alkan, Prof Dr

CONTACT

Musa Güçlüer, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

August 9, 2025

First Posted

February 2, 2026

Study Start

January 15, 2026

Primary Completion

February 15, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 2, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations