Study Stopped
Anticipated that results would not be conclusive
Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response
1 other identifier
interventional
106
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2005
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJune 24, 2010
June 1, 2010
4 years
January 14, 2008
June 23, 2010
Conditions
Keywords
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
EXPERIMENTALlumbosacral joint manipulation
2
EXPERIMENTALlumbar passive range of motion
3
OTHERlie on exam table for 3 minutes
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Ingersoll, PhD
University of Virginia
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