NCT00601341

Brief Summary

The purpose of this study is to gain a better understanding of the effects of lumbopelvic manual therapy on lower extremity biomechanics and arthrogenic muscle response. As a result of this study, we also hope that physical therapists, athletic trainers, and other physical medicine rehabilitation providers will gain a better understanding of lower extremity injuries and have the scientific evidence to provide patients with techniques which would allow for efficient return to activities of daily living without restrictions and possibly prevent future injuries and minimize risk of osteoarthritis. The objectives of this study are to:

  • Determine the amount and duration of arthrogenic muscle response of quadriceps muscles following lumbopelvic joint manipulation.
  • Determine the effects of lumbopelvic joint manipulation on temporospatial parameters of gait such cadence, step length, velocity and mean peak lower extremity joint moments.
  • Determine if a correlation exists between patellofemoral joint pain and lumbopelvic joint dysfunction.
  • Determine the amount of change in clinical outcome measure scores following lumbopelvic joint manipulation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 24, 2010

Status Verified

June 1, 2010

Enrollment Period

4 years

First QC Date

January 14, 2008

Last Update Submit

June 23, 2010

Conditions

Keywords

arthralgiajoint painknee injuriesknee jointlow back pain

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular response (central activation ratio), characteristics of gait (stride length, step length, etc.), joint moments

    All study visits up to day 21

Secondary Outcomes (2)

  • Characteristics of gait (stride length, step length, etc.)

    All study visits up to day 21

  • Orthopedic special tests and questionnaires

    Concluding at day 21

Study Arms (3)

1

EXPERIMENTAL

lumbosacral joint manipulation

Other: lumbosacral joint manipulation

2

EXPERIMENTAL

lumbar passive range of motion

Other: lumbar passive range of motion

3

OTHER

lie on exam table for 3 minutes

Other: No active intervention

Interventions

lumbosacral joint manipulation

1

lumbar passive range of motion

2

Lie on exam table for 3 minutes

3

Eligibility Criteria

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

You may qualify if:

  • Physician referral to physical therapy for treatment of insidious onset of lumbopelvic or lower extremity musculoskeletal dysfunction or individuals with chronic lumbopelvic or lower extremity musculoskeletal dysfunction not wishing to seek physical therapy services.
  • Unilateral or Bilateral hip pain or dysfunction
  • Unilateral or Bilateral knee pain or dysfunction with two of the following symptoms:
  • Pain reproduced with patella compression, squatting, prolonged sitting, going up or down stairs, or isometric quadriceps contraction.
  • Unilateral or Bilateral ankle pain or dysfunction
  • Lumbopelvic pain or dysfunction
  • Control subjects who volunteer in response to advertisements will have healthy, pain free, back, hips, knees, and ankles.

You may not qualify if:

  • Participants who are outside of age range (to ensure bony maturity while reducing the prevalence of age related degenerative changes and hypomobility.)
  • Ligamentous insufficiency, meniscus damage, patellar tendonitis, history of subluxation/dislocation
  • Participants with signs indicating nerve root compression (contraindication for lumbopelvic joint manipulation)
  • Pain extending below knee
  • Positive Straight Leg Raise
  • Decreased lower extremity manual muscle test (Below 4/5), decreased sensation, hyporeflexia
  • Participants demonstrating upper motor neuron signs (contraindication to lumbopelvic manipulation)
  • Hyperreflexia
  • Pathological reflexes
  • Participants who have had lower extremity or spine surgery
  • Participants who are unable to run for 5 minutes.
  • Participants with ankylosing spondylitis (contraindication for lumbopelvic manipulation)
  • Participants with spinal hypermobility or spondylolisthesis. (contraindication for lumbopelvic manipulation)
  • Participants with spinal cord disease or cauda equina. (contraindication for lumbopelvic manipulation)
  • Participants with osteoporosis. (contraindication for lumbopelvic joint manipulation)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

ArthralgiaKnee InjuriesLow Back Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeg InjuriesWounds and InjuriesBack Pain

Study Officials

  • Christopher Ingersoll, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 28, 2008

Study Start

May 1, 2005

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

June 24, 2010

Record last verified: 2010-06

Locations