Patellofemoral Pain SyndromeNCT06592898
Different Squatting Modes in the Rehabilitation of Patellofemoral Pain Syndrome
A study testing straight leg raise, wall squat and direct squat in people with Patellofemoral Pain Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study take 84 patients with Patellofemoral Pain Syndrome in Peking University Third Hospital during January to September in 2023 as subjects, aiming to explore the efficacy and intervention effects of three different static squat modes including straight leg raise, wall squat, direct squat and wall squat assisted… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- straight leg raise, wall squat and direct squat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of PFPS.
- Age between 20 and 45 years (to reduce the risk of suffer from patellofemoral joint bone joint)
- Have no other treatments before the experiment.
- Sign the informed consent form.
Who cannot join
- Patients with a history of knee surgery.
- With other lower limb injuries such as meniscus tear, bursitis, ligament injury, patellar tendon injury, joint degeneration, etc.
- With a history of dislocation and subluxation of patellofemoral joint.
- With cardiovascular vessels, lung, kidney and other important organs.
- Not available to use mobile phone APP
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Different Squatting Modes in the Rehabilitation of Patellofemoral Pain Syndrome:A Prospective Randomized Controlled Trial
This study take 84 patients with Patellofemoral Pain Syndrome in Peking University Third Hospital during January to September in 2023 as subjects, aiming to explore the efficacy and intervention effects of three different static squat modes including straight leg raise, wall squat, direct squat and wall squat assisted by elastic bands for patients with PFPS, in order to providing theoretical basis and effective guidance for future home rehabilitation of patients with PFPS combined with mobile health.
Read the detailed description
Background：Static squat has been widely used in the treatments of patellofemoral pain syndrome (PFPS), but no study has assessed which static squat modes is more effective .This study aimed to compare the effects of three different static squat modes on patients with patellofemoral pain syndrome .
Methods：Investigators included 84 patients with patellofemoral pain syndrome, a 6-week training period using a mobile phone app with angle recognition function, patients were devided into 4 groups based on different static squat modes. Kujala score, Lysholm score, VAS-W score, VAS-U score,thigh circumference, peak torque of knee extension, and peak torque of knee flexion on the affected side were used to assess efficacy.Two-way ANOVA was conducted to determine the differences within and between groups.Paired-samples t-test was used for intergroup comparisons, and one-way ANOVA was applied for intergroup comparisons. Chi-square tests were performed on categorical data.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- straight leg raise, wall squat, direct squat, wall squat assisted by elastic bands
- Keywords
- patellofemoral pain syndrome, static squat, rehabilitation
- 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.
straight leg raiseBehavioural
The patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath.
wall squatBehavioural
The subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly.
direct squatBehavioural
The subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle. The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.
wall squat assisted by elastic bandsBehavioural
Based on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group: straight leg raise | Active comparator | The patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath. Receives: Behavioral: straight leg raise |
| Experimental group A: wall squat | Experimental | The subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly. Receives: Behavioral: wall squat |
| Experimental group B: direct squat | Experimental | The subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle.The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. Receives: Behavioral: direct squat |
| Experimental group C: wall squat assisted by elastic bands | Experimental | Based on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. Receives: Behavioral: wall squat assisted by elastic bands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of three different static squat modes for home rehabilitation of patients with patellofemoral pain syndrome.
Investigators assessed the efficacy of wall squat, direct squat and wall squat assisted by elastic bands by measure Kujala score, Lysholm score, VAS-W score, VAS-U score, thigh circumference score, results of peak knee torque in isokinetic muscle strength test and peak knee moment results for isokinetic muscle strength test by using USA Biodex isokinetic muscle strength tester at 3rd week and 6th week. Before statistics, the measurement data are tested for normality and homogeneity of variance. The data meet the conditions of normal distribution and homogeneity of variance, and the statistical results are expressed in the form of mean ± standard deviation (x ± s).Count data were analyzed by the chi-square test. P \<0.05 represents a statistically significant difference.
Higher values for all scores proved better intervention treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592898
- Sponsor's protocol ID
- M2023013
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Squatting Modes in the Rehabilitation of Patellofemoral Pain Syndrome:A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06592898
- Acronym / sponsor ID
- M2023013
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, static squat, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 19 Sep 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.
This study take 84 patients with Patellofemoral Pain Syndrome in Peking University Third Hospital during January to September in 2023 as subjects, aiming to explore the efficacy and intervention effects of three different static squat modes including straight leg raise, wall squat, direct squat and wall squat assisted by elastic bands for patients with PFPS, in order to providing theoretical basis and effective guidance for future home rehabilitation of patients with PFPS combined with mobile health.
Detailed description
Background：Static squat has been widely used in the treatments of patellofemoral pain syndrome (PFPS), but no study has assessed which static squat modes is more effective .This study aimed to compare the effects of three different static squat modes on patients with patellofemoral pain syndrome .
Methods：Investigators included 84 patients with patellofemoral pain syndrome, a 6-week training period using a mobile phone app with angle recognition function, patients were devided into 4 groups based on different static squat modes. Kujala score, Lysholm score, VAS-W score, VAS-U score,thigh circumference, peak torque of knee extension, and peak torque of knee flexion on the affected side were used to assess efficacy.Two-way ANOVA was conducted to determine the differences within and between groups.Paired-samples t-test was used for intergroup comparisons, and one-way ANOVA was applied for intergroup comparisons. Chi-square tests were performed on categorical data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group: straight leg raise | Active comparator | Behavioral: straight leg raiseThe patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath. |
| Experimental group A: wall squat | Experimental | Behavioral: wall squatThe subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly. |
| Experimental group B: direct squat | Experimental | Behavioral: direct squatThe subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle.The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. |
| Experimental group C: wall squat assisted by elastic bands | Experimental | Behavioral: wall squat assisted by elastic bandsBased on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of PFPS.
Key exclusion criteria (5 listed)
- Patients with a history of knee surgery.
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 |
|---|---|---|
| straight leg raiseThe patient was supine position, one knee angle was 90°, the foot was flatted on the ground. The ankle was flexed to contract the quadriceps on the other side. Then straighten the knee joint and the hip was 30° and lift the thigh, the heel was about 20cm away from the ground, and put down the lower limb after 2 seconds. Ten times are in a group, each practice has 5 groups, rest between the groups is 1 minute. Practice 5 times a week, practice on both sides, take uniform respiration without holding breath. | Behavioural | Control group: straight leg raise |
| wall squatThe subjects' upper body was upright, the distance between feet was same as width of shoulder, and hands were placed on each side of the body or above the thighs. Tiptoes were towards the front, and perpendicular to the wall. The distance between the wall and heel was about a foot long, and the back was close to the wall, squatted slowly. | Behavioural | Experimental group A: wall squat |
| direct squatThe subjects stood on the flat ground, the upper body was upright, the distance between feet was same as width of shoulder, and tiptoes were towards the front. The trunk was adjusted forward according to the Angle of static squat. The specific method is to adjust the trunk position to the line of the shoulder joint and knee joint perpendicular to the ground. Knee joint can bend at a large angle. The center of gravity was between the feet, put hands in front of body.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. | Behavioural | Experimental group B: direct squat |
| wall squat assisted by elastic bandsBased on wall squat, subjects put elastic band of 20 pounds between the thighs, open thighs and feet at a low speed, so that the elastic bands were slightly deformed and sence of resistance was obvious on the outside of the thighs.The angle was set at 30° for the first two weeks, increased to 45° after two weeks, and set at 60° for the last two weeks. | Behavioural | Experimental group C: wall squat assisted by elastic bands |
Primary outcome
Efficacy of three different static squat modes for home rehabilitation of patients with patellofemoral pain syndrome.
Time frame: 6 weeks
Investigators assessed the efficacy of wall squat, direct squat and wall squat assisted by elastic bands by measure Kujala score, Lysholm score, VAS-W score, VAS-U score, thigh circumference score, results of peak knee torque in isokinetic muscle strength test and peak knee moment results for isokinetic muscle strength test by using USA Biodex isokinetic muscle strength tester at 3rd week and 6th week. Before statistics, the measurement data are tested for normality and homogeneity of variance. The data meet the conditions of normal distribution and homogeneity of variance, and the statistical results are expressed in the form of mean ± standard deviation (x ± s).Count data were analyzed by the chi-square test. P \<0.05 represents a statistically significant difference. Higher values for all scores proved better intervention treatment.
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing straight leg raise, wall squat and direct squat in people with Patellofemoral Pain Syndrome, run by Peking University Third Hospital at 1 site in China.
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 5 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 19 Sep 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 China. 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?
Efficacy of three different static squat modes for home rehabilitation of patients with patellofemoral pain syndrome. (time frame: 6 weeks). 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 19 Sep 2024.