NCT03051412

Brief Summary

Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females, which is associated with decreased quality of life and physical activity levels. PFP is highly persistent, with up to 50% of adolescents reporting persistent pain at both one and two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older individuals with chronic pain, however, less is known about this in conditions such as PFP, which is common in younger populations. Additionally it is unknown if these characteristics return to similar values as healthy controls, when symptoms resolve. The aim of this study will be to compare pain sensitivity in individuals with PFP, compared to those with a previous history of PFP who currently are pain-free, and a control group with no history of knee pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

February 9, 2017

Last Update Submit

November 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Conditioned pain modulation

    Conditioned pain modulation (CPM) will be assessed using cuff algometry

    Baseline

Secondary Outcomes (4)

  • Pressure pain thresholds will be measured around the lower leg and forearm

    baseline

  • Pressure Pain thresholds at the knee

    baseline

  • Temporal summation of pain

    baseline

  • Pressure detection & pressure tolerance threshold assessed by cuff algometry

    baseline

Study Arms (3)

Current Patellofemoral Pain

This group has current patellofemoral pain

Other: No Intervention

Recovered

This group has a previous history of patellofemoral pain, but currently self reports as recovered.

Other: No Intervention

Control

This is a control group with no history of knee pain.

Other: No Intervention

Interventions

No intervention

ControlCurrent Patellofemoral PainRecovered

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population will consist of young females. One group will include participants with current longstanding patellofemoral pain, while a second group will include those with a history of pain, who self report as recovered, and a control group, who has no previous history of knee pain.

You may qualify if:

  • Female
  • Age 18-30years
  • Current longstanding patellofemoral pain

You may not qualify if:

  • Patients who have sustained a traumatic injury to the hip, knee, ankle or the lumbar spine within the past 3 month will be excluded.
  • Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathy, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper) if they occur in isolation (without patellofemoral pain).
  • Recovered Group:
  • Previous history of patellofemoral pain, reporting no current knee pain
  • Female
  • Aged 18-30 years
  • Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathi, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper)
  • Other pain conditions
  • Control:
  • Female
  • Aged 18-30
  • Current knee or other other musculoskeletal pain
  • Previous history of knee or musculoskeletal pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sinead Holden, PhD

    Research Unit for General Practice, Department of Clinical Medicine, Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post- Doctoral Research Fellow

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

February 22, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations