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Knee PainNCT00601341

Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response

A study testing lumbosacral joint manipulation, lumbar passive range of motion and No active intervention in people with Knee Pain and Hip Pain, run by University of Virginia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Knee Pain, Hip Pain, Ankle Pain
What is being tested?
lumbosacral joint manipulation, lumbar passive range of motion and No active intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
May 2005to Nov 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Participants who are outside of age range (to ensure bony maturity while reducing the prevalence of age related degenerative changes and hypomobility.)
  • Participants with knee pain which does not fit inclusion criteria.
  • 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
Show all 24Show fewer
  • 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)
  • Participants with rheumatoid arthritis. (contraindication to lumbopelvic joint manipulation.)
  • Participants who may be currently pregnant. (contraindication for electrical stimulation and lumbopelvic joint manipulation.)
  • Participants with traumatic spine or lower extremity injury within past 6 months
  • Participants who are currently participating or have participated in a lower extremity musculoskeletal rehabilitation program within the past 6 months.
  • Participants who have had previous adverse reactions to electrical stimulation (i.e. electrode burns.)
  • Participants who have a demand-type cardiac pacemaker (contraindication for electrical stimulation)
  • Participants with diagnosis of cancer (current cancer is a contraindication for electrical stimulation and relative contraindication for lumbopelvic joint manipulation)
  • Participants who are unable to give consent or are unable to understand procedures of experiment.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.
Read the detailed description

It is well known that musculoskeletal dysfunction at one joint is not limited to the joint itself and can be related to dysfunction at joints proximal or distal in the kinetic chain. Recent research has focused on the relationship of altered lower extremity kinematics and common musculoskeletal pathologies.

Pain is often associated with musculoskeletal pathologies and is one of the strongest stimuli affecting functional activities in a negative manner. Following injury or chronic dysfunction, inhibitory neurons decrease the ability of musculature to fully recruit excitatory motor neurons. This can lead to aberrant movement patterns and different activation of muscles. Muscle inhibition has been attributed as a possible source of altered motor activation patterns. Pain can be a result or cause of musculoskeletal dysfunction and does not necessarily precede inhibition, but can have a contributing effect. The presence of muscle inhibition is considered a limiting factor in the rehabilitation of musculoskeletal pathologies. If muscle inhibition is properly addressed, individuals and athletes alike, should be able to more appropriately meet the demands of the activities with a decreased risk of future injury.

One technique used to determine presence of muscle inhibition is to measure the ability of the muscle to produce a maximal voluntary isometric contraction and compare values with the ability of the contralateral muscle. Since the contralateral limb may also experience muscle inhibition,it is difficult to obtain an accurate measurement of the amount of muscle inhibition occurring in the ipsilateral limb. A suggested solution is utilize the burst-superimposition technique which provides the muscle with a supramaximal stimulus to recruit any remaining muscle fibers which have not been stimulated.

Treatment of muscle inhibition is multifaceted. Utilization of manual therapy techniques such as joint manipulation or mobilization directed at the lumbopelvic region have been shown to be successful in disinhibiting lower extremity muscles. Previous studies have demonstrated sacroiliac joint manipulation disinhibited the quadriceps muscle in individuals with anterior knee pain. One of the limitations was these studies only observed an immediate decrease of quadriceps inhibition and the duration of the treatment effect was unknown. Effects of disinhibition of other lower extremity muscles and duration of disinhibition have not been determined at this time. It is also unknown what effects manual therapy treatments directed at the lumbopelvic region have on functional activities such as walking, squatting, or ascending/descending stairs. By examining these effects, we will be attempting to provide scientific evidence to validate common clinical practices in rehabilitative medicine.

Being tested
lumbosacral joint manipulation, lumbar passive range of motion, No active intervention
Keywords
arthralgia, joint pain, knee injuries, knee joint, low back pain
Medical subject headings
Arthralgia, Knee Injuries, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lumbosacral joint manipulationOther

    lumbosacral joint manipulation

  • lumbar passive range of motionOther

    lumbar passive range of motion

  • No active interventionOther

    Lie on exam table for 3 minutes

Study groups in NCT00601341
Study groupRoleWhat they receive
1Experimentallumbosacral joint manipulation
Receives: Other: lumbosacral joint manipulation
2Experimentallumbar passive range of motion
Receives: Other: lumbar passive range of motion
3Otherlie on exam table for 3 minutes
Receives: Other: No active intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: All study visits up to day 21

Secondary outcomes (2)
  1. Characteristics of gait (stride length, step length, etc.)

    Measured: All study visits up to day 21

  2. Orthopedic special tests and questionnaires

    Measured: Concluding at day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2009 (estimated)
  4. Study completionNov 2009

Why it stopped: Anticipated that results would not be conclusive

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00601341
Sponsor's protocol ID
11730
Status last verified
Jun 2010
First submitted
14 Jan 2008
Last updated
24 Jun 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing lumbosacral joint manipulation, lumbar passive range of motion and No active intervention in people with Knee Pain and Hip Pain, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Anticipated that results would not be conclusive). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuromuscular response (central activation ratio), characteristics of gait (stride length, step length, etc.), joint moments (time frame: All study visits up to day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2010.

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