NCT06681961

Brief Summary

An imbalance in the activation and onset time of the vastus medialis oblique (VMO) and vastus lateralis (VL) muscles may be one of the primary causes of PFPS. Several studies have discussed various exercise methods believed to selectively contract the (VMO) muscle for treating patellofemoral pain syndrome. VMO activity is higher during static closed-chain tasks combined with hip adduction, indicating that performing hip adduction exercises may selectively strengthen the VMO muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 27, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2019

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 4, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

Patellofemoral pain syndromeVastus medialis obliquusSquattingHip adduction

Outcome Measures

Primary Outcomes (7)

  • Amplitudes of muscle activation (unit: %MVC)

    represented the mean RMSs for each muscle which was normalized by the maximal voluntary contractions (MVC).

    pre-intervention and after 8-week intervention

  • VMO/VL ratio

    represents the amplitude ratio of VMO relative to VL.

    pre-intervention and after 8-week intervention

  • Onset time (unit: msec)

    at 200 ms before the beginning of the trial, as the baseline, the onset of EMG activation was identified as the point at which the EMG amplitude was more than three standard deviations from the baseline level for at least 25 ms.

    pre-intervention and after 8-week intervention

  • VMO - VL (unit: msec)

    represented the onset time differences of VMO relative to VL, with a positive (negative) value indicating a delayed (early) onset time of VMO relative to VL.

    pre-intervention and after 8-week intervention

  • Q angle (unit: degree)

    The angle was calculated with the intersection formed by two lines crossing the center of the patella. The first line went from the ASIS to the center of the patella and the second from the anterior tuberosity of the tibia to the center of the patella.

    pre-intervention and after 8-week intervention

  • The visual analogue scale (VAS) (unit: mm)

    VAS was used to assess pain severity. The participants were asked to mark their pain levels on a 100-mm ruler (ranging from 0 = "no pain" to 100 = "unbearable pain") before and after the exercise program.

    pre-intervention and after 8-week intervention

  • patellofemoral pain severity scale (PSS) (unit: score)

    PSS was used to measure PFPS associated with functional activities over the past week. The scale comprises 10 items, including climbing/descending stairs, squatting, walking, jogging, running/sprinting, participating in a sport, sitting with knees bent (for 20 min), kneeling, resting, and following an activity. The maximum score was 100 points. The participants rated their pain on a 100-mm VAS, ranging from 0 = "no pain" to 100 = "unbearable pain".

    pre-intervention and after 8-week intervention

Study Arms (2)

squatting with hip adduction (SQU-HA) group

EXPERIMENTAL

The participants stood equally on both legs on the floor with their feet shoulder-width apart and angled outward at 20°-30°. After a warm-up, the participants performed 45° squats with squeezing a Swiss ball of 18-cm diameter at a slow speed of 2 s for flexion and extension from the standing posture by using a commercial metronome. The squatting with knee flexion from 0° to 45° was the safest for people with PFPS.

Other: squatting with hip adduction (SQU-HA) group

squatting (SQU) group

OTHER

The participants stood equally on both legs on the floor with their feet shoulder-width apart and angled outward at 20°-30°. After a warm-up, the participants performed 45° squats at a slow speed of 2 s for flexion and extension from the standing posture by using a commercial metronome. The squatting with knee flexion from 0° to 45° was the safest for people with PFPS.

Other: squatting with hip adduction (SQU-HA) group

Interventions

The intervention comprised three sets of 15 repetitions with resting 5-min between sets, followed by IT band stretching for five repetitions. Each participant performed the respective exercise 5 days a week, with 2 days of rest, for 8 weeks.

Also known as: squatting (SQU) group
squatting (SQU) groupsquatting with hip adduction (SQU-HA) group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-50 years.
  • Pain around the patella at least two of the following activities¬-standing up after prolonged sitting, going up and down the stairs, running, jumping, squatting, kneeling, and high-angle knee flexion for a long time.
  • Knee joint pain for ≥3 months.
  • Pain level of ≥ 30 mm on a 100-mm visual analog scale (VAS).

You may not qualify if:

  • Had a history of patellar subluxation, dislocation, or knee surgery.
  • Had central or peripheral neurological pathology.
  • Had an obvious knee joint deformity or lower extremity malalignment.
  • Experienced severe knee joint pain (VAS) score \> 80 mm), or received nonsteroidal anti-inflammatory drugs, injections, or physical therapy within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Wei-Hsien Hong, PhD

    China Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This was a prospective, randomized-controlled trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Thirty PFPS participants were randomly assigned to conventional squatting (SQU) (n=15) or squatting with hip adduction (SQU-HA) (n=15) groups. Participants were blinded to the interventions used in the other group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
China Medical University

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 12, 2024

Study Start

November 27, 2017

Primary Completion

November 30, 2018

Study Completion

January 5, 2019

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations