Patellofemoral Pain SyndromeNCT00445224
Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome
A study testing Hip Progressive Resistive Exercise and Quad Progressive Resistive Exercises in people with Patellofemoral Pain Syndrome, run by Timothy Uhl at 1 site in United States.
Trial summary
Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people. Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps… Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Hip Progressive Resistive Exercise and Quad Progressive Resistive Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting
- insidious onset of symptoms not related to trauma
- pain with compression of the patella
- pain on palpation of the patellar facets
Who cannot join
- symptoms present for less than one month
- clinical evidence of other knee pathology
- history of recent knee surgery within past one year
- history of patellar dislocations or subluxations
- current significant injury affecting other lower extremity joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Early Hip Strengthening to Early Quadriceps Strengthening in the Treatment of Females With Patellofemoral Pain
Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people. Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to determine how different exercises affect pain, strength, muscle activity, and function in female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed with PFPS who initially participate in a hip strengthening program will report a greater perceived level of function, greater strength, less pain, and improved neuromuscular activity than those who participate in a progressive quadriceps strengthening intervention.
Read the detailed description
Methods: Thirty-three females with PFPS will perform either initial hip strengthening (hip group) or initial quadriceps strengthening (quad group) for 4 weeks, prior to 4 weeks of a similar program of functional weight-bearing exercises. Self-reported pain, function, and functional strength were measured. Isometric strength was assessed for hip abductors, external rotators, and knee extensors. A mixed-model analysis of variance will be used to determine group differences over time.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Hip Progressive Resistive Exercise, Quad Progressive Resistive Exercises
- Keywords
- Knee pain, 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.
Hip Progressive Resistive ExerciseOther
Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.
Quad Progressive Resistive ExercisesOther
Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.
| Study group | Role | What they receive |
|---|---|---|
| Hip Progressive Resistive Exercises | Experimental | Exercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach. Receives: Other: Hip Progressive Resistive Exercise |
| Quad Progressive Resistive Exercises | Active comparator | Exercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach.. Receives: Other: Quad Progressive Resistive Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Measured: weekly
Subjective Function by Lower Extremity Functional Scale Report Form
Measured: Baseline, Mid-Intervention, and Post-Intervention
Visual Analog Pain Scale
Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Measured: 8 week
Secondary outcomes (4)
Strength by Isometric Dynamometer
Measured: Baseline, Mid, and Post-Intervention
Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent
Measured: Baseline, Mid and Post-Intervention
Objective Function by Step-down Task for 30 Seconds
Measured: Baseline, Mid, and Post-Intervention
Hip Abduction Strength
Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Uhl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Uhl, University of Kentucky
- Investigators
- Timothy Uhl, PhD, ATC, PT, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445224
- Sponsor's protocol ID
- 07-0138-F2L
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2007
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: willing to share strength and patient reported outcome data at pre, mid, and post testing time points.
Publications
Dolak KL, Silkman C, Medina McKeon J, Hosey RG, Lattermann C, Uhl TL. Hip strengthening prior to functional exercises reduces pain sooner than quadriceps strengthening in females with patellofemoral pain syndrome: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Aug;41(8):560-70. doi: 10.2519/jospt.2011.3499. Epub 2011 Jun 7.
PubMed 21654093
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Hip Strengthening to Early Quadriceps Strengthening in the Treatment of Females With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT00445224
- Acronym / sponsor ID
- 07-0138-F2L
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Knee pain, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Timothy UhlUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 5 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people. Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to determine how different exercises affect pain, strength, muscle activity, and function in female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed with PFPS who initially participate in a hip strengthening program will report a greater perceived level of function, greater strength, less pain, and improved neuromuscular activity than those who participate in a progressive quadriceps strengthening intervention.
Detailed description
Methods: Thirty-three females with PFPS will perform either initial hip strengthening (hip group) or initial quadriceps strengthening (quad group) for 4 weeks, prior to 4 weeks of a similar program of functional weight-bearing exercises. Self-reported pain, function, and functional strength were measured. Isometric strength was assessed for hip abductors, external rotators, and knee extensors. A mixed-model analysis of variance will be used to determine group differences over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Progressive Resistive Exercises | Experimental | Other: Hip Progressive Resistive ExerciseExercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach. |
| Quad Progressive Resistive Exercises | Active comparator | Other: Quad Progressive Resistive ExercisesExercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach.. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting
- insidious onset of symptoms not related to trauma
- pain with compression of the patella
- pain on palpation of the patellar facets
Key exclusion criteria (5 listed)
- symptoms present for less than one month
- clinical evidence of other knee pathology
- history of recent knee surgery within past one year
- history of patellar dislocations or subluxations
- current significant injury affecting other lower extremity joints
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 |
|---|---|---|
| Hip Progressive Resistive ExerciseHip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature. | Other | Hip Progressive Resistive Exercises |
| Quad Progressive Resistive ExercisesQuad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics. | Other | Quad Progressive Resistive Exercises |
Primary outcome
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
Time frame: weekly
0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Subjective Function by Lower Extremity Functional Scale Report Form
Time frame: Baseline, Mid-Intervention, and Post-Intervention
Visual Analog Pain Scale
Time frame: 8 week
Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
4 secondary outcomes
Strength by Isometric Dynamometer
Time frame: Baseline, Mid, and Post-Intervention
Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent
Time frame: Baseline, Mid and Post-Intervention
Objective Function by Step-down Task for 30 Seconds
Time frame: Baseline, Mid, and Post-Intervention
Hip Abduction Strength
Time frame: 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21654093Dolak KL, Silkman C, Medina McKeon J, Hosey RG, Lattermann C, Uhl TL. Hip strengthening prior to functional exercises reduces pain sooner than quadriceps strengthening in females with patellofemoral pain syndrome: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Aug;41(8):560-70. doi: 10.2519/jospt.2011.3499. Epub 2011 Jun 7.
- Individual participant dataSharing planned: Undecided. willing to share strength and patient reported outcome data at pre, mid, and post testing time points.
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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.
Timothy Uhl, PhD, ATC, PT study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Progressive Resistive Exercise and Quad Progressive Resistive Exercises in people with Patellofemoral Pain Syndrome, run by Timothy Uhl at 1 site in United States.
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 28 Mar 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week) (time frame: weekly). The study lists 3 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 NCT00445224, 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 28 Mar 2017.