NCT02402673

Brief Summary

Problem: Adolescent patellofemoral pain (PFP) is a major problem worldwide and affects 7% of adolescents. Adolescents with PFP have long-lasting severe pain and low quality of life. Current treatment is ineffective for more than 60% and new treatment approaches are needed. Solution: A novel multidimensional diagnostic approach combining imaging, physical activity level and pain sensitisation in adolescents with PFP. This approach will enable the identification of adolescents with PFP who benefits from a new treatment strategy using activity modification to reduce loading of the patellofemoral joint and graded exercises to improve loading capacity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

March 12, 2015

Last Update Submit

January 27, 2018

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Self-reported recovery on 7-point Likert scale

    12 weeks.

Secondary Outcomes (5)

  • Patellofemoral Osteoarthritis Outcome Score (PFOOS)

    4 and 12 weeks and 6 and 12 months.

  • Pressure Pain thresholds using handheld allometry and cuff-algometry

    4 and 12 weeks.

  • Activity level.

    Continuously from 0 to 4 week follow-up.

  • Isometric strength of the knee and hip.

    4 and 12 weeks.

  • Self-reported recovery on 7-point Likert scale

    4 weeks, and 6 and 12 months.

Study Arms (1)

Intervention

OTHER
Other: Temporary activity modification and graded exercises

Interventions

Temporary activity modification and graded exercisesOTHER
Intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • insidious onset of anterior knee or retro- patellar pain of more than 6 weeks duration
  • provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or stair climbing; tenderness on palpation of the patella, pain when stepping down or double leg squatting

You may not qualify if:

  • Concomitant injury or pain from the hip, lumbar spine or other knee structures
  • previous knee surgery
  • self-reported patellofemoral instability
  • current use of physiotherapy for treating knee pain
  • A diagnosis of other knee conditions that may present as anterior knee pain (Mb. Osgood Schlatter, iliotibial band syndrome, sinding-larsen-Johansson, patella tendinopathy or similar).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Universitetshospital

Aalborg, The North Denmark Region, 9000, Denmark

Location

Related Publications (1)

  • Rathleff MS, Graven-Nielsen T, Holmich P, Winiarski L, Krommes K, Holden S, Thorborg K. Activity Modification and Load Management of Adolescents With Patellofemoral Pain: A Prospective Intervention Study Including 151 Adolescents. Am J Sports Med. 2019 Jun;47(7):1629-1637. doi: 10.1177/0363546519843915. Epub 2019 May 16.

    PMID: 31095417DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Per Hölmich, Dr.Med

    Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark

    STUDY CHAIR

  • Thomas Graven-Nielsen, PhD

    Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark

    STUDY CHAIR

  • Kristian Thorborg, PhD

    Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post.doc

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 30, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

DK(1)