search
Back to results

Core Stabilization for the Treatment of Anterior Knee Pain

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
core stabilization
lower extremity training only
Sponsored by
Youngstown State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring patellofemoral pain syndrome, abdominal muscles

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

    1. experienced during or after activity
    2. prolonged sitting
    3. with stair climbing or descending
    4. squatting
    5. 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.

Sites / Locations

  • Poland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core stabilization

Lower extremity training only

Arm Description

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.

This arm with receive 6 weeks of impairment based stretching and strengthening to restore function.

Outcomes

Primary Outcome Measures

Lower extremity functional scale
LEFS is a functional scale that estimates how much the subject's function is disrupted by their condition.

Secondary Outcome Measures

Kujala anterior knee pain scale
The Kujala scale measures the amount and impact of anterior knee pain on the subject's life
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
Numeric pain rating scale
The NPRS measures the subject's current knee pain

Full Information

First Posted
April 23, 2014
Last Updated
January 23, 2017
Sponsor
Youngstown State University
search

1. Study Identification

Unique Protocol Identification Number
NCT02123602
Brief Title
Core Stabilization for the Treatment of Anterior Knee Pain
Official Title
The Effects of a Trunk Strengthening Program on Anterior Knee Pain in an Adolescent Athletic Population: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Youngstown State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
patellofemoral pain syndrome, abdominal muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Core stabilization
Arm Type
Experimental
Arm Description
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.
Arm Title
Lower extremity training only
Arm Type
Active Comparator
Arm Description
This arm with receive 6 weeks of impairment based stretching and strengthening to restore function.
Intervention Type
Other
Intervention Name(s)
core stabilization
Intervention Type
Other
Intervention Name(s)
lower extremity training only
Primary Outcome Measure Information:
Title
Lower extremity functional scale
Description
LEFS is a functional scale that estimates how much the subject's function is disrupted by their condition.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Kujala anterior knee pain scale
Description
The Kujala scale measures the amount and impact of anterior knee pain on the subject's life
Time Frame
6 weeks
Title
Patient specific functional scale
Description
The PSFS rates subject's ability to do the 3 functional activities that are bothered the most by the knee pain
Time Frame
6 weeks
Title
Numeric pain rating scale
Description
The NPRS measures the subject's current knee pain
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Global rating of change
Description
The GRoC measures the subject's overall estimation of improvement.
Time Frame
6 weeks
Title
Self-reported percent recovery
Description
The subject reports their estimated overall percentage of improvement from the start of care
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ken Learman, PhD, PT
Phone
330.941.7125
Email
klearman@ysu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Morris, DPT
Phone
330.707.9064
Email
mjmorris107@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth E Learman, PhD, PT
Organizational Affiliation
Youngstown State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poland Medical Center
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Morris, DPT
Phone
330-757-7888

12. IPD Sharing Statement

Citations:
PubMed Identifier
16526831
Citation
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.
Results Reference
background
PubMed Identifier
19843565
Citation
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.
Results Reference
background
PubMed Identifier
22149696
Citation
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.
Results Reference
background
PubMed Identifier
20929936
Citation
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.
Results Reference
background
PubMed Identifier
15733046
Citation
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.
Results Reference
background

Learn more about this trial

Core Stabilization for the Treatment of Anterior Knee Pain

We'll reach out to this number within 24 hrs