- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123602
Core Stabilization for the Treatment of Anterior Knee Pain
January 23, 2017 updated by: Kenneth Learman, Youngstown State University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ken Learman, PhD, PT
- Phone Number: 330.941.7125
- Email: klearman@ysu.edu
Study Contact Backup
- Name: Michael Morris, DPT
- Phone Number: 330.707.9064
- Email: mjmorris107@yahoo.com
Study Locations
-
-
Ohio
-
Poland, Ohio, United States, 44514
- Recruiting
- Poland Medical Center
-
Contact:
- Michael Morris, DPT
- Phone Number: 330-757-7888
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Core stabilization
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.
|
|
Active Comparator: Lower extremity training only
This arm with receive 6 weeks of impairment based stretching and strengthening to restore function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kujala anterior knee pain scale
Time Frame: 6 weeks
|
The Kujala scale measures the amount and impact of anterior knee pain on the subject's life
|
6 weeks
|
Patient specific functional scale
Time Frame: 6 weeks
|
The PSFS rates subject's ability to do the 3 functional activities that are bothered the most by the knee pain
|
6 weeks
|
Numeric pain rating scale
Time Frame: 6 weeks
|
The NPRS measures the subject's current knee pain
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global rating of change
Time Frame: 6 weeks
|
The GRoC measures the subject's overall estimation of improvement.
|
6 weeks
|
Self-reported percent recovery
Time Frame: 6 weeks
|
The subject reports their estimated overall percentage of improvement from the start of care
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth E Learman, PhD, PT, Youngstown State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- van 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.
- Collins 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.
- Earl 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.
- Koumantakis 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
April 23, 2014
First Submitted That Met QC Criteria
April 24, 2014
First Posted (Estimate)
April 25, 2014
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #093-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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