Vibration on Patellofemoral Joint Pain After ACLR

NCT ID: NCT05501210

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-06-01

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.

Detailed Description

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. The influence of such injury can often be lifelong as it increases the patient's risk of developing degenerative musculoskeletal problems like osteoarthritis, and eventually affects the patient's quality of life. 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. The prevalence of patients developing PFJ osteoarthritis ranges from 14.8-26.5% for post-operation 2-5 years, and the percentage is even higher after more than 6 years post-operation.

Symptoms of PFJ osteoarthritis include swelling, notably reduced quadriceps strength, and pain on PFJ compression. Though the mechanism of how ACLR contributes to the development of PFJ osteoarthritis is not completely clear yet, inflammation and damage to PFJ articular cartilage and alteration of vastus medialis function, which is common after ACLR, might play a role in the development of PFJ osteoarthritis. A more than 30% decrease in quadriceps muscles strength had been reported by previous study. Decrease in size of rectus femoris, vastus medialis and vastus lateralis had also been observed. Though there was no significant difference in the vastus medialis/vastus lateralis, the decrease in strength and size of the quadricep muscles could possibly affect the stability of PFJ, increasing the chance of developing PFJ osteoarthritis.

Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. More and more rehabilitation facilities have equipped the WBV machine and make this therapy more easily accessible. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. It has also shown effectiveness in decreasing osteoarthritic knee pain and enhancing knee function in chronic elderly knee osteoarthritis. Though the exact mechanism of the therapy is not yet very clear, it is believed that it is related to the "tonic vibration reflex". Skeletal muscles undergo small changes in muscle length during the vibration generated by the machine. It elicits the "tonic vibration reflex", activates muscle spindles and mediated neural signals. Another possible mechanism is that the vibration provides cortical stimulation and increases the corticomotor excitability. Both of them train the neuromuscular system to response faster, achieving the above-mentioned benefits.

There are different types of WBV machines, providing vertical, horizontal or pivoting vibration, and the amplitude and frequency of the vibration can be adjusted on the machine. Many studies have been conducted using different duration, amplitude and frequency of vibration. A "standard protocol" for WBV therapy is yet to be developed. 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.

Conservative and effective approaches for relieving pain are needed for knee osteoarthritis patients and, among these, pulsed electromagnetic fields (PEMF) are emerging with promising results. In vitro studies have demonstrated that PEMF therapy is effective in reducing chondrocyte apoptosis and MMP-13 expression of knee cartilage in ovariectomized rats and in favourably affecting cartilage homeostasis. PEMF was evaluated for function, a significant improvement was observed 8 weeks after initiation of treatment, and no significant association was found between the use of PEMF and the occurrence of adverse events.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Patellofemoral Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WBV + PEMF Group

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.

Group Type: EXPERIMENTAL

WBV

Intervention Type: DEVICE

Whole body vibration (WBV) therapy

PEMF

Intervention Type: DEVICE

Pulsed electromagnetic fields (PEMF)

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

WBV only

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.

Group Type: ACTIVE_COMPARATOR

WBV

Intervention Type: DEVICE

Whole body vibration (WBV) therapy

Interventions

WBV

Whole body vibration (WBV) therapy

Intervention Type: DEVICE

PEMF

Pulsed electromagnetic fields (PEMF)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 to 60

2. Unilateral ACLR

3. Persisting PFJ pain

4. Isolated symptomatic site or pathology

Exclusion Criteria

1. Age > 60

2. Bilateral ACLR

3. Revision ACLR

4. Any rheumatological diseases

5. Previous contralateral knee injury

6. Any knee osteoarthritis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Tim-Yun Michael ONG

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Michael Tim-Yun Ong, Prof.

Role: CONTACT

michael.ong@cuhk.edu.hk

85235052723

Facility Contacts

Michael Tim-Yun Ong

Role: primary

michael.ong@cuhk.edu.hk

26364171

Other Identifiers

2020.674

Identifier Type: -

Identifier Source: org_study_id