River Valley Health Clinic
Edmonton, Alberta, T6G 2C8, Canada
NCT Number: NCT01761838
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2C8, Canada
SMT is a common manual therapy for treating patients with mechanical low back pain (LBP). SMT is defined as a high velocity, low amplitude thrust technique. Specifically, the clinician stands beside a supine patient. The patient is passively side-bent towards the side to be manipulated. The clinician passively rotates the patient and then delivers a high velocity, low amplitude thrust to the anterior superior iliac spine in a posteroinferior direction. SMT is indicated for patients with LBP judged to have spinal hypomobility or malalignment. Recently, our collaborators have discovered that LBP subjects who benefit from SMT can be identified prior to treatment by a five-item clinical prediction rule. Compared to non-responders, those who respond to SMT have: 1) more than 30% decrease in the modified Oswestry Disability Index score, 2) a significant and immediate decrease in spinal stiffness, and 3) a concurrent change in lumbar multifidus muscle activity. Taken together, the physical changes experienced by SMT responders alone provide an unique opportunity to better understand the mechanisms underlying SMT.
Since spinal stiffness is an important physical indicator of SMT response, it is important to understand the causal relation between pain, paraspinal/trunk muscle activity and spinal stiffness. Although research has shown positive correlation between pain and muscle activity, and between paraspinal muscle activity and spinal stiffness, the causal relation between pain, paraspinal/trunk muscle activity and spinal stiffness remains unknown. Given this background, an induction of temporary benign experimental pain to asymptomatic individuals can help clarify such causal relation and improve our understanding of physical responses in responders following pain resolution by SMT.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
Other names: High velocity, low amplitude spinal manipulative therapy, spinal manipulation
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.
No treatment
Time frame: baseline, Day 3, and 1 week
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Time frame: baseline, Day 3, and 1 week
It is a scale to measure the perceived pain intensity by the participants.
Time frame: Baseline, Day 3, and 1 week
The diagram will be used to demarcate the location and area of symptoms
Time frame: Baseline, Day 3, and 1 week
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
Time frame: Baseline, Day 3, and 1 week
The spinal stiffness of participants will be measured by a validated mechanical indentation machine. Briefly, a 60 N load will be applied to the third lumbar spinous process and the corresponding spinal tissue deformations will be measured. The spinal stiffness will be calculated from the force-displacement curve of each indentation.
Time frame: At the third visit (1 week from the baseline)
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
Time frame: At the beginning and immediately after the first visit (an expected average of 1 hour apart)
It records the anatomical features of the lumbar spine and the changes in lumbar disc diffusion during the first session (an expected average of 1-hour duration).
Time frame: Baseline
It assesses the fear avoidance behaviour of participants
Time frame: Baseline, Day 3, and 1 week
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Time frame: 1 week after baseline
It measures the perceived change of body function from the first visit.
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
The spinal stiffness of participants will be measured by a validated mechanical indentation machine. Briefly, a 60 N load will be applied to the third lumbar spinous process and the corresponding spinal tissue deformations will be measured. The spinal stiffness will be calculated from the force-displacement curve of each indentation.
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
It is a scale to measure the perceived pain intensity by the participants.
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
The diagram will be used to demarcate the location and area of symptoms
Time frame: Before the injection in each session
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Time frame: Before the injection in the first session
It measures the perceived fear of pain under different hypothetical painful experiences.
Time frame: Before the injection in the first session
It assesses the fear avoidance behaviour of participants
Time frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
University of Alberta
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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