Patellofemoral Pain SyndromeNCT03468491
The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
A study testing combined training and Proximal training in people with Patellofemoral Pain Syndrome and Hallux Valgus, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Hallux Valgus
- What is being tested?
- combined training and Proximal training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 30 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High physical activity level (running at least 5 times/week and at least 2 hours/time)
- Presenting anterior/retropatellar knee pain in the past 6 months
- At least two of the following activities provocated symptom: Prolonged sitting, ascending and/or descending stairs, squatting, kneeling, running, limping
- Not having any pathologies of knee joint (ligament tear, menisci injury, patellofemoral joint dislocation, tendinitis, bursitis…etc.)
- With hallux valgus angle>15°
- With 1st metatarsophalangeal joint instability
- 20~40 y/o
Who cannot join
- Lower extremities osteoarthritis
- Systematic diseases such as rheumatoid arthritis, systemic lupus erythematosus, DM…etc.
- Lower extremities fracture history
- Surgical history of lower extremities
- Neurological pathology that would interfere with gait
- Hallux could not be corrected to neutral through passive correction
- Low back pain and/or sacroiliac joint dysfunction in the past six months
- Excessive femoral anteversion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus
Read the detailed description
This will be a single-blind, experimental study with two treatment groups. A total of 30 college athletes with PFPS and hallux valgus and majoring in long distance running or soccer, or recreational runners in Taipei metropolitan area will be recruited. A set of clinical examination will be conducted to rule out abnormal knee structures, pathologies, or injuries apart from PFPS. The lower extremity alignment as well as hip and knee kinematics during a step down test will be tracked using Noraxon's myoMOTION system. Muscle activation of the muscles controlling the hip and knee movements during the step down test will be recorded using TELEmyo DTS of Noraxon. Hallux valgus angle will be measured with surface markers on photographs. Knee pain level will be rated in a visual analog scale. The investigators will analyze the data with Statistical Product and Service Solutions (SPSS) for Windows. Repeated-measure ANOVAs will be used to examine group-by-time interaction on all the outcome variables. All significance level will be set at 0.05.
- Conditions
- Patellofemoral Pain Syndrome, Hallux Valgus
- Being tested
- combined training, Proximal training
- Keywords
- Patellofemoral pain syndrome, Runner, First ray instability, Lower extremity closed chain exercise
- Medical subject headings
- Patellofemoral Pain Syndrome, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined trainingOther
Also called hallux valgus correction, lower extremity neuromuscular exercises
The whole intervention period will last for 6 weeks, 2 visits per week, 1 hour per visit in the Research Building Room 630 of National Yang Ming University. All programs will be under the supervision of a physiotherapist with 2-year experience individually. 1. Hallux valgus correction: 1.1 Joint alignment correction (Grade II joint mobilization, 10 times/set, 3 sets/visit) - 1st MTP joint distraction - Proximal talofibular joint anteroposterior glide - (Grade III joint mobilization if any restriction being found) 1.2 Biomechanical taping (using Dynamic taping, 1 time/ visit, keep the taping for 2 days minimum) 1.3 Foot intrinsic muscle strengthening (10 times/set for each exercise, 3 sets/visit): - Short foot exercise - Toespread out exercise - Heel-rise exercises 2. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 2.1 Single lunge 2.2 Stepping down 2.3 Vertical squat 2.4 Vertical jumping
Proximal trainingOther
Also called lower extremity neuromuscular exercises
- Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 1.1 Single lunge 1.2 Stepping down 1.3 Vertical squat 1.4 Vertical jumping All exercises will first start on firm surface without additional resistance/weight. Later, settings will be gradually shifted into on firm surface with resisted band from random direction, on a cushion with/ without resisted band, on a BOSU balance trainer. Progression are made every 2 weeks ideally, while adjustments may be taken into concern due to individual differences.
| Study group | Role | What they receive |
|---|---|---|
| Combined training group | Experimental | Biomechanical taping will first being applied to the participants of the combined training group. They will be asked to perform following exercises in this session afterwards. As the treatment session goes on, a set of foot intrinsic muscle strengthening exercise and lower extremity neuromuscular exercise will be provided. Receives: Other: combined training |
| Proximal training group | Active comparator | For participants of the proximal training group, only a set of lower extremity neuromuscular exercise will be provided. This set of exercises is designed to be the same as for participants of combined training group. Receives: Other: Proximal training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of femur in step-down test
displacement recorded in cm/BMI
Measured: changes from baseline and after 6 weeks of intervention
Displacement of tibia in step-down test
displacement recorded in cm/BMI
Measured: changes from baseline and after 6 weeks of intervention
Knee pain level
The level of knee pain during daily activities will be quantified with visual analogue scale.
Measured: changes from baseline and after 6 weeks of intervention
Changes of pain-free running distance
The changes of pain-free running distance will be recorded in kilometers.
Measured: changes from baseline and after 6 weeks of intervention
EMG amplitude of knee extensor
amplitude recorded in %MVC
Measured: changes from baseline and after 6 weeks of intervention
EMG amplitude of knee flexor
amplitude recorded in %MVC
Measured: changes from baseline and after 6 weeks of intervention
EMG amplitude of hip external rotator
amplitude recorded in %MVC
Measured: changes from baseline and after 6 weeks of intervention
changes of the muscle activation time between vastus medialis oblique and vastus lateralis
changes of the muscle activation time recorded in second
Measured: changes from baseline and after 6 weeks of intervention
Secondary outcomes (6)
Tibiofemoral angle in relaxed standing
recorded in degree
Measured: changes from baseline and after 6 weeks of intervention
Hallux valgus angle in relaxed standing
recorded in degree
Measured: changes from baseline and after 6 weeks of intervention
Navicular drop
navicular position changes between sitting and relaxed standing, recording in cm
Measured: changes from baseline and after 6 weeks of intervention
Arch height index
arch height in one leg standing, recording in the ratio of arch height and truncated foot length
Measured: changes from baseline and after 6 weeks of intervention
Hip rotation angle in relaxed standing
recorded in degree
Measured: changes from baseline and after 6 weeks of intervention
Knee rotation angle in relaxed standing
recorded in degree
Measured: changes from baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jun 2018
- Primary completion30 Sep 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- be945a7ts@gmail.com Chen, PhD, Study director, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468491
- Sponsor's protocol ID
- YM106048F
- Status last verified
- May 2018
- First submitted
- 6 Feb 2018
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis IS, Powers CM. Patellofemoral pain syndrome: proximal, distal, and local factors, an international retreat, April 30-May 2, 2009, Fells Point, Baltimore, MD. J Orthop Sports Phys Ther. 2010 Mar;40(3):A1-16. doi: 10.2519/jospt.2010.0302. No abstract available.
PubMed 20195028
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03468491
- Acronym / sponsor ID
- YM106048F
- Conditions
- Patellofemoral Pain Syndrome, Hallux Valgus
- Keywords
- Patellofemoral pain syndrome, Runner, First ray instability, Lower extremity closed chain exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 16 Mar 2018 (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.
The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus
Detailed description
This will be a single-blind, experimental study with two treatment groups. A total of 30 college athletes with PFPS and hallux valgus and majoring in long distance running or soccer, or recreational runners in Taipei metropolitan area will be recruited. A set of clinical examination will be conducted to rule out abnormal knee structures, pathologies, or injuries apart from PFPS. The lower extremity alignment as well as hip and knee kinematics during a step down test will be tracked using Noraxon's myoMOTION system. Muscle activation of the muscles controlling the hip and knee movements during the step down test will be recorded using TELEmyo DTS of Noraxon. Hallux valgus angle will be measured with surface markers on photographs. Knee pain level will be rated in a visual analog scale. The investigators will analyze the data with Statistical Product and Service Solutions (SPSS) for Windows. Repeated-measure ANOVAs will be used to examine group-by-time interaction on all the outcome variables. All significance level will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined training group | Experimental | Other: combined trainingBiomechanical taping will first being applied to the participants of the combined training group. They will be asked to perform following exercises in this session afterwards. As the treatment session goes on, a set of foot intrinsic muscle strengthening exercise and lower extremity neuromuscular exercise will be provided. |
| Proximal training group | Active comparator | Other: Proximal trainingFor participants of the proximal training group, only a set of lower extremity neuromuscular exercise will be provided. This set of exercises is designed to be the same as for participants of combined training group. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- High physical activity level (running at least 5 times/week and at least 2 hours/time)
- Presenting anterior/retropatellar knee pain in the past 6 months
- At least two of the following activities provocated symptom: Prolonged sitting, ascending and/or descending stairs, squatting, kneeling, running, limping
- Not having any pathologies of knee joint (ligament tear, menisci injury, patellofemoral joint dislocation, tendinitis, bursitis…etc.)
- With hallux valgus angle>15°
Key exclusion criteria (8 listed)
- Lower extremities osteoarthritis
- Systematic diseases such as rheumatoid arthritis, systemic lupus erythematosus, DM…etc.
- Lower extremities fracture history
- Surgical history of lower extremities
- Neurological pathology that would interfere with gait
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 |
|---|---|---|
| combined trainingAlso: hallux valgus correction, lower extremity neuromuscular exercisesThe whole intervention period will last for 6 weeks, 2 visits per week, 1 hour per visit in the Research Building Room 630 of National Yang Ming University. All programs will be under the supervision of a physiotherapist with 2-year experience individually. 1. Hallux valgus correction: 1.1 Joint alignment correction (Grade II joint mobilization, 10 times/set, 3 sets/visit) - 1st MTP joint distraction - Proximal talofibular joint anteroposterior glide - (Grade III joint mobilization if any restriction being found) 1.2 Biomechanical taping (using Dynamic taping, 1 time/ visit, keep the taping for 2 days minimum) 1.3 Foot intrinsic muscle strengthening (10 times/set for each exercise, 3 sets/visit): - Short foot exercise - Toespread out exercise - Heel-rise exercises 2. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 2.1 Single lunge 2.2 Stepping down 2.3 Vertical squat 2.4 Vertical jumping | Other | Combined training group |
| Proximal trainingAlso: lower extremity neuromuscular exercises1. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 1.1 Single lunge 1.2 Stepping down 1.3 Vertical squat 1.4 Vertical jumping All exercises will first start on firm surface without additional resistance/weight. Later, settings will be gradually shifted into on firm surface with resisted band from random direction, on a cushion with/ without resisted band, on a BOSU balance trainer. Progression are made every 2 weeks ideally, while adjustments may be taken into concern due to individual differences. | Other | Proximal training group |
Primary outcome
Displacement of femur in step-down test
Time frame: changes from baseline and after 6 weeks of intervention
displacement recorded in cm/BMI
Displacement of tibia in step-down test
Time frame: changes from baseline and after 6 weeks of intervention
displacement recorded in cm/BMI
Knee pain level
Time frame: changes from baseline and after 6 weeks of intervention
The level of knee pain during daily activities will be quantified with visual analogue scale.
Changes of pain-free running distance
Time frame: changes from baseline and after 6 weeks of intervention
The changes of pain-free running distance will be recorded in kilometers.
EMG amplitude of knee extensor
Time frame: changes from baseline and after 6 weeks of intervention
amplitude recorded in %MVC
EMG amplitude of knee flexor
Time frame: changes from baseline and after 6 weeks of intervention
amplitude recorded in %MVC
EMG amplitude of hip external rotator
Time frame: changes from baseline and after 6 weeks of intervention
amplitude recorded in %MVC
changes of the muscle activation time between vastus medialis oblique and vastus lateralis
Time frame: changes from baseline and after 6 weeks of intervention
changes of the muscle activation time recorded in second
6 secondary outcomes
Tibiofemoral angle in relaxed standing
Time frame: changes from baseline and after 6 weeks of intervention
Hallux valgus angle in relaxed standing
Time frame: changes from baseline and after 6 weeks of intervention
Navicular drop
Time frame: changes from baseline and after 6 weeks of intervention
Arch height index
Time frame: changes from baseline and after 6 weeks of intervention
Hip rotation angle in relaxed standing
Time frame: changes from baseline and after 6 weeks of intervention
Knee rotation angle in relaxed standing
Time frame: changes from baseline and after 6 weeks of intervention
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 13 Aug 2024.
- Background: PubMed 20195028Davis IS, Powers CM. Patellofemoral pain syndrome: proximal, distal, and local factors, an international retreat, April 30-May 2, 2009, Fells Point, Baltimore, MD. J Orthop Sports Phys Ther. 2010 Mar;40(3):A1-16. doi: 10.2519/jospt.2010.0302. No abstract available.
- 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.
be945a7ts@gmail.com Chen, PhD study director
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined training and Proximal training in people with Patellofemoral Pain Syndrome and Hallux Valgus, run by National Yang Ming Chiao Tung University 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 7 inclusion and 8 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 13 Aug 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?
Displacement of femur in step-down test (time frame: changes from baseline and after 6 weeks of intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468491, which also lists 1 linked publication.
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 13 Aug 2024.