PFPSNCT06681961
Effects of a Squatting With Hip Adduction in Patients With Patellofemoral Pain Syndrome
A study testing squatting with hip adduction (SQU-HA) group in people with PFPS, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PFPS
- What is being tested?
- squatting with hip adduction (SQU-HA) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2017to 5 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Effects of a Dynamics Closed Kinetic Chain Exercise Combination With Hip Adduction in Patients With Patellofemoral Pain Syndrome
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.
Read the detailed description
Patellofemoral pain syndrome (PFPS) poses challenges in motor control and pain management, especially regarding balanced muscle activation of the vastus medialis oblique (VMO) and vastus lateralis (VL). This study introduces a home-based PFPS rehabilitation approach involving a squat exercise program with hip adduction, examining its effects on motor control and clinical outcomes. Thirty PFPS participants were randomly assigned to conventional squatting (SQU) or squatting with hip adduction (SQU-HA) groups. Participants performed exercises five days a week for 8 weeks, with pre- and post-assessments capturing clinical measures and motor control indicators using electromyography (EMG). This home-based program, integrating hip adduction into squats, enhances motor control, reduces knee stress, and improves daily function, ensuring continued care post-pandemic.
- Conditions
- PFPS
- Being tested
- squatting with hip adduction (SQU-HA) group
- Keywords
- Patellofemoral pain syndrome, Vastus medialis obliquus, Squatting, Hip adduction
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
squatting with hip adduction (SQU-HA) groupOther
Also called squatting (SQU) group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: squatting with hip adduction (SQU-HA) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitudes of muscle activation (unit: %MVC)
represented the mean RMSs for each muscle which was normalized by the maximal voluntary contractions (MVC).
Measured: pre-intervention and after 8-week intervention
VMO/VL ratio
represents the amplitude ratio of VMO relative to VL.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: pre-intervention and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start27 Nov 2017
- Primary completion30 Nov 2018
- Study completion5 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFPSStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Hsien Hong, China Medical University Hospital
- Investigators
- Wei-Hsien Hong, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681961
- Sponsor's protocol ID
- CMUH106-REC1-014
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of a Dynamics Closed Kinetic Chain Exercise Combination With Hip Adduction in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06681961
- Acronym / sponsor ID
- CMUH106-REC1-014
- Conditions
- PFPS
- Keywords
- Patellofemoral pain syndrome, Vastus medialis obliquus, Squatting, Hip adduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 5 Jan 2019 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patellofemoral pain syndrome (PFPS) poses challenges in motor control and pain management, especially regarding balanced muscle activation of the vastus medialis oblique (VMO) and vastus lateralis (VL). This study introduces a home-based PFPS rehabilitation approach involving a squat exercise program with hip adduction, examining its effects on motor control and clinical outcomes. Thirty PFPS participants were randomly assigned to conventional squatting (SQU) or squatting with hip adduction (SQU-HA) groups. Participants performed exercises five days a week for 8 weeks, with pre- and post-assessments capturing clinical measures and motor control indicators using electromyography (EMG). This home-based program, integrating hip adduction into squats, enhances motor control, reduces knee stress, and improves daily function, ensuring continued care post-pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| squatting with hip adduction (SQU-HA) group | Experimental | Other: squatting with hip adduction (SQU-HA) groupThe 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. |
| squatting (SQU) group | Other | Other: squatting with hip adduction (SQU-HA) groupThe 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| squatting with hip adduction (SQU-HA) groupAlso: squatting (SQU) groupThe 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. | Other | squatting (SQU) group, squatting with hip adduction (SQU-HA) group |
Primary outcome
Amplitudes of muscle activation (unit: %MVC)
Time frame: pre-intervention and after 8-week intervention
represented the mean RMSs for each muscle which was normalized by the maximal voluntary contractions (MVC).
VMO/VL ratio
Time frame: pre-intervention and after 8-week intervention
represents the amplitude ratio of VMO relative to VL.
Onset time (unit: msec)
Time frame: pre-intervention and after 8-week intervention
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.
VMO - VL (unit: msec)
Time frame: pre-intervention and after 8-week intervention
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.
Q angle (unit: degree)
Time frame: pre-intervention and after 8-week intervention
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.
The visual analogue scale (VAS) (unit: mm)
Time frame: pre-intervention and after 8-week intervention
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.
patellofemoral pain severity scale (PSS) (unit: score)
Time frame: pre-intervention and after 8-week intervention
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Hsien Hong, PhD principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing squatting with hip adduction (SQU-HA) group in people with PFPS, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitudes of muscle activation (unit: %MVC) (time frame: pre-intervention and after 8-week intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.