NCT01761838|Completed
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Sponsor study identifier
interventional
103
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)The purpose of this study is to compare changes in spinal stiffness and back muscle activity between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic participants. Additionally, the investigators wanted to compare the amount of lumbar degeneration between SMT responders, non-responders and asymptomatic participants. This study also determines if the presence of pain modifies post-SMT spinal stiffness and back muscle activity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2013
Actual (reported)January 7, 2013
Actual (reported)October 2014
Actual (reported)October 2014
Actual (reported)Change of Modified Oswestry Low Back Pain Disability Index
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
baseline, Day 3, and 1 week
Change of 11-point Numeric Pain Rating Scale
It is a scale to measure the perceived pain intensity by the participants.
baseline, Day 3, and 1 week
Change in Body Pain diagram
The diagram will be used to demarcate the location and area of symptoms
Baseline, Day 3, and 1 week
To investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity.
To investigate the sequential changes in spinal stiffness and back muscle activity of asymptomatic participants over time without any intervention. Participants of this arm can volunteer for an additional experimental pain protocol after their third visit (at 1 week) to investigate the effects of experimental pain on the changes of spinal stiffness and back muscle activity using a randomized crossover design (injecting 5% hypertonic saline or 0.9% isotonic saline to the interspinous ligaments at L3 to L5 levels in random order in two additional visits).
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
A randomized crossover design is used to investigate the changes in spinal stiffness and back muscle activity of asymptomatic participants following an experimental pain induction procedure. Specifically, asymptomatic participants attend two separate sessions 5 days apart. Participants will receive 0.3 ml of 5% hypertonic saline or 0.9% isotonic saline in random order into the interspinous ligaments at L3 to L5 levels. The resulting temporal changes in pain intensity, spinal stiffness and trunk muscle activity following saline injections will be monitored. During the second session, the participants will undergo the same procedures but with the previously unused saline concentration.
River Valley Health Clinic
Edmonton, Alberta, T6G 2C8, Canada
Gregory N Kawchuk, PhD, DC
Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
103 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2013
First Posted
January 7, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Walking Away From Back Pain, One Step at a Time
Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging
Baseline, Day 3, and 1 week
Change of spinal stiffness testing by a mechanical indentation machine
Baseline, Day 3, and 1 week
Electromyography of trunk muscles
At the third visit (1 week from the baseline)
Magnetic resonance imaging of lumbar region for participants with low back pain
At the beginning and immediately after the first visit (an expected average of 1 hour apart)
Fear Avoidance Beliefs Questionnaire
Baseline
Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Spinal stiffness assessment by mechanical indentation machine in the pain induction experiment
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Electromyography of trunk muscles in the pain induction experiment
Before the injection, immediately after the injection, and 25-minute after the injection in each session
To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT
No treatment
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Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
August 11, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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