Patellofemoral Pain SyndromeNCT02123602
Core Stabilization for the Treatment of Anterior Knee Pain
A study testing core stabilization and lower extremity training only in people with Patellofemoral Pain Syndrome, run by Youngstown State University at 1 site in United States.
Trial summary
The investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- core stabilization and lower extremity training only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects between 13-20 years of age clinically diagnosed with anterior knee pain.
- Pain should be peripatellar and should include at least 3 of the following:
- experienced during or after activity
- prolonged sitting
- with stair climbing or descending
- squatting
- kneeling.
- The subject should be active for at least 30 minutes per day.
Who cannot join
- Previous knee surgery
- Signs and symptoms of a specific structural diagnosis not consistent with AKP such as meniscal, ACL, PCL, or collateral ligament tears, pain referral from hip or lumbar spine (determined during examination), traumatic patellar dislocation, an inability to adequately understand or communicate in English.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Poland Medical Center
Poland, Ohio, 44514
Michael Morris, DPT, 330-757-7888
About this study
Official title: The Effects of a Trunk Strengthening Program on Anterior Knee Pain in an Adolescent Athletic Population: a Randomized Clinical Trial
The investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- core stabilization, lower extremity training only
- Keywords
- patellofemoral pain syndrome, abdominal muscles
- 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.
core stabilizationOther
lower extremity training onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization | Experimental | This arm will receive 3 weeks of core stabilization training followed by 3 weeks of lower extremity stretching and strengthening as appropriate to address impairments noted in the examination and to progress function. Receives: Other: core stabilization |
| Lower extremity training only | Active comparator | This arm with receive 6 weeks of impairment based stretching and strengthening to restore function. Receives: Other: lower extremity training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity functional scale
LEFS is a functional scale that estimates how much the subject's function is disrupted by their condition.
Measured: 6 weeks
Secondary outcomes (3)
Kujala anterior knee pain scale
The Kujala scale measures the amount and impact of anterior knee pain on the subject's life
Measured: 6 weeks
Patient specific functional scale
The PSFS rates subject's ability to do the 3 functional activities that are bothered the most by the knee pain
Measured: 6 weeks
Numeric pain rating scale
The NPRS measures the subject's current knee pain
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 posted25 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Learman, Youngstown State University
- Investigators
- Kenneth E Learman, PhD, PT, Principal investigator, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123602
- Sponsor's protocol ID
- #093-2014
- Status last verified
- Jan 2017
- First submitted
- 23 Apr 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
PubMed 16526831van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Verhaar JA, Willemsen SP, Koes BW, Bierma-Zeinstra SM. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial. BMJ. 2009 Oct 20;339:b4074. doi: 10.1136/bmj.b4074.
PubMed 19843565Collins NJ, Bisset LM, Crossley KM, Vicenzino B. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials. Sports Med. 2012 Jan 1;42(1):31-49. doi: 10.2165/11594460-000000000-00000.
PubMed 22149696Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
PubMed 20929936Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
PubMed 15733046
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Trunk Strengthening Program on Anterior Knee Pain in an Adolescent Athletic Population: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02123602
- Acronym / sponsor ID
- #093-2014
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, abdominal muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- 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 investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilization | Experimental | Other: core stabilizationThis arm will receive 3 weeks of core stabilization training followed by 3 weeks of lower extremity stretching and strengthening as appropriate to address impairments noted in the examination and to progress function. |
| Lower extremity training only | Active comparator | Other: lower extremity training onlyThis arm with receive 6 weeks of impairment based stretching and strengthening to restore function. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subjects between 13-20 years of age clinically diagnosed with anterior knee pain.
- Pain should be peripatellar and should include at least 3 of the following:
- The subject should be active for at least 30 minutes per day.
Key exclusion criteria (2 listed)
- Previous knee surgery
- Signs and symptoms of a specific structural diagnosis not consistent with AKP such as meniscal, ACL, PCL, or collateral ligament tears, pain referral from hip or lumbar spine (determined during examination), traumatic patellar dislocation, an inability to adequately understand or communicate in English.
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 |
|---|---|---|
| core stabilization | Other | Core stabilization |
| lower extremity training only | Other | Lower extremity training only |
Primary outcome
Lower extremity functional scale
Time frame: 6 weeks
LEFS is a functional scale that estimates how much the subject's function is disrupted by their condition.
3 secondary outcomes
Kujala anterior knee pain scale
Time frame: 6 weeks
Patient specific functional scale
Time frame: 6 weeks
Numeric pain rating scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Background: PubMed 16526831Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
- Background: PubMed 19843565van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Verhaar JA, Willemsen SP, Koes BW, Bierma-Zeinstra SM. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial. BMJ. 2009 Oct 20;339:b4074. doi: 10.1136/bmj.b4074.
- Background: PubMed 22149696Collins NJ, Bisset LM, Crossley KM, Vicenzino B. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials. Sports Med. 2012 Jan 1;42(1):31-49. doi: 10.2165/11594460-000000000-00000.
- Background: PubMed 20929936Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
- Background: PubMed 15733046Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
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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.
Kenneth E Learman, PhD, PT principal investigator
Youngstown State 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 core stabilization and lower extremity training only in people with Patellofemoral Pain Syndrome, run by Youngstown State University 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ken Learman, PhD, PT (330.941.7125, klearman@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity functional scale (time frame: 6 weeks). 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 NCT02123602, which also lists 5 linked publications.
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 24 Jan 2017.