NCT02123602

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

4.3 years

First QC Date

April 23, 2014

Last Update Submit

January 23, 2017

Conditions

Patellofemoral Pain Syndrome

Keywords

patellofemoral pain syndromeabdominal muscles

Outcome Measures

Primary Outcomes (1)

  • Lower extremity functional scale

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

    6 weeks

Secondary Outcomes (3)

  • Kujala anterior knee pain scale

    6 weeks

  • Patient specific functional scale

    6 weeks

  • Numeric pain rating scale

    6 weeks

Other Outcomes (2)

  • Global rating of change

    6 weeks

  • Self-reported percent recovery

    6 weeks

Study Arms (2)

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.

Other: core stabilization

Lower extremity training only

ACTIVE COMPARATOR

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

Other: lower extremity training only

Interventions

core stabilizationOTHER
Core stabilization
lower extremity training onlyOTHER
Lower extremity training only

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poland Medical Center

Poland, Ohio, 44514, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 16526831BACKGROUND

  • 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.

    PMID: 19843565BACKGROUND

  • 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.

    PMID: 22149696BACKGROUND

  • 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.

    PMID: 20929936BACKGROUND

  • 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.

    PMID: 15733046BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Kenneth E Learman, PhD, PT

    Youngstown State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ken Learman, PhD, PT

CONTACT

330.941.7125klearman@ysu.edu

Michael Morris, DPT

CONTACT

330.707.9064mjmorris107@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 25, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2018

Study Completion

June 1, 2019

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(1)