NCT01637480

Brief Summary

The purpose of this study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in people without anterior knee pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 12, 2015

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

June 25, 2012

Last Update Submit

January 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Electromyography (EMG)

    Electromyography (EMG) onset time of the gluteus maximus, gluteus medius, vastus medialis oblique, and vastus lateralis muscles.

    The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention.

Secondary Outcomes (1)

  • Pain Visual Analog Scale (VAS)

    The Pain Visual Analog Scale (VAS) will be assessed before and 45 min after the lower back treatment (lumbopelvic manipulation) for participants in the patellofemoral pain syndrome group on Day 2 only.

Study Arms (2)

Patellofemoral Pain Syndrome

EXPERIMENTAL

Participants with Patellofemoral Pain Syndrome

Other: Lumbopelvic manipulation

Healthy control

ACTIVE COMPARATOR

Age- and gender-matched participants without Patellofemoral Pain Syndrome

Other: Lumbopelvic manipulation

Interventions

High-velocity-low-amplitude thrust manipulation of the lumbopelvic region

Healthy controlPatellofemoral Pain Syndrome

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • insidious onset of symptoms of non-traumatic origin
  • pain with patellar facet palpation or compression
  • subjective knee pain rating of at least 3/10 on the pain visual analog scale during at least one of the following activities:
  • ascending stair
  • descending stair
  • kneeling
  • squatting
  • running
  • jumping
  • prolong sitting for more than 20 minutes

You may not qualify if:

  • history of spine, hip or knee surgery
  • history of hip pathology or other knee condition
  • current significant injury of any lower extremity joints
  • pregnancy
  • sign of nerve root compression
  • osteoporosis or history of compression fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University, School of Physical Therapy - Dallas Campus

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Ammar M Al Abbad, Master

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 12, 2015

Record last verified: 2014-11

Locations