NCT05501210

Brief Summary

Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a majority of ACL injuries. Even after ACL reconstruction (ACLR) surgeries, study has reported a 30-50% prevalence of developing patellofemoral joint (PFJ) pain in 1-2 years post-operation. Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. Though duration of WBV may differ according to the effect of interest, several studies have had positive results with a 8 week WBV therapy in increasing muscle strength, proprioception, and post-ACLR knee functions. Further investigation on the underlying mechanism and possible application are to be continued to explore more possibilities with the WBV therapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
40mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2022Sep 2029

Study Start

First participant enrolled

March 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

March 22, 2022

Last Update Submit

March 17, 2026

Conditions

Keywords

ACLRPatellofemoral jointWhole Body vibrationKnee function

Outcome Measures

Primary Outcomes (1)

  • Change of The Knee injury and Osteoarthritis Outcome Score Patellofemoral subscale (KOOS-PF)

    The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral OA. It contains 11 items with 3 subscale : Stiffness, Pain, Quality of life (QOL).

    pre intervention and 8 weeks post intervention

Secondary Outcomes (3)

  • Isokinetic muscle strength

    pre intervention and 8 weeks post intervention

  • Muscle thickness

    pre intervention and 8 weeks post intervention

  • The Numeric Pain Rating Scale (NPRS)

    pre intervention and 8 weeks post intervention

Study Arms (3)

WBV + PEMF Group

EXPERIMENTAL

Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV + PEMF" groups will receive PEMF after WBV session.

Device: WBVDevice: PEMF

Control Group

NO INTERVENTION

Subjects in control group will perform static squat, single leg squat and lunges without vibration.

WBV only

ACTIVE COMPARATOR

Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV" groups will not receive PEMF after WBV session.

Device: WBV

Interventions

WBVDEVICE

Whole body vibration (WBV) therapy

WBV + PEMF GroupWBV only
PEMFDEVICE

Pulsed electromagnetic fields (PEMF)

WBV + PEMF Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 60
  • Unilateral ACLR
  • Persisting PFJ pain
  • Isolated symptomatic site or pathology

You may not qualify if:

  • Age \> 60
  • Bilateral ACLR
  • Revision ACLR
  • Any rheumatological diseases
  • Previous contralateral knee injury
  • Any knee osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesPatellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Central Study Contacts

Michael Tim-Yun Ong, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned into either vibration or control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

August 15, 2022

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations