The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain Degeneration of Lumbosacral Intervertebral Disc Muscle Weakness Spine Stiffness |
Other: SMT for low back pain patients Other: Pain induction (optional) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures |
- Change of Modified Oswestry Low Back Pain Disability Index [ Time Frame: baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]It is a questionnaire to assess the participants' perceived low back pain related functional disability.
- Change of 11-point Numeric Pain Rating Scale [ Time Frame: baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]It is a scale to measure the perceived pain intensity by the participants.
- Change in Body Pain diagram [ Time Frame: Baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]The diagram will be used to demarcate the location and area of symptoms
- Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging [ Time Frame: Baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
- Change of spinal stiffness testing by a mechanical indentation machine [ Time Frame: Baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]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.
- Electromyography of trunk muscles [ Time Frame: At the third visit (1 week from the baseline) ] [ Designated as safety issue: No ]Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
- Magnetic resonance imaging of lumbar region [ Time Frame: 1 month before or after the first visit ] [ Designated as safety issue: No ]
- Fear Avoidance Beliefs Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]It assesses the fear avoidance behaviour of participants
- Change in Borg Category-Ratio Scale of Perceived Exertion [ Time Frame: Baseline, Day 3, and 1 week ] [ Designated as safety issue: No ]It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
- Global Rating Of Change [ Time Frame: 1 week after baseline ] [ Designated as safety issue: No ]It measures the perceived change of body function from the first visit.
- Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
- Spinal stiffness assessment by mechanical indentation machine in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]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.
- Electromyography of trunk muscles in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
- 11-point Numeric Pain Rating Scale in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]It is a scale to measure the perceived pain intensity by the participants.
- Body Pain diagram in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]The diagram will be used to demarcate the location and area of symptoms
- Modified Oswestry low back pain disability index in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]It is a questionnaire to assess the participants' perceived low back pain related functional disability.
- Fear of Pain Questionnaire - III in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]It measures the perceived fear of pain under different hypothetical painful experiences.
- Fear Avoidance Beliefs Questionnaire in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]It assesses the fear avoidance behaviour of participants
- Borg Category-Ratio Scale of Perceived Exertion in the pain induction experiment [ Time Frame: A single visit ] [ Designated as safety issue: No ]It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SMT for low back pain patients
To investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity.
|
Other: SMT for low back pain patients
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
Other Names:
|
|
Asymptomatic arm
To investigate the sequential changes of 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 at their third visit (at 1 week) to investigate the changes of spinal stiffness and back muscle activity following a pain induction procedure (injecting 5% hypertonic saline solution to the interspinous ligaments at L3 to L5 levels).
|
Other: Pain induction (optional)
To investigate the changes of spinal stiffness and back muscle activity of asymptomatic participants following the experimental pain induction by injecting 0.3 ml of 5% hypertonic saline solution to the interspinous ligaments at L3 to L5 levels.
|
Detailed Description:
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 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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Self ambulatory participants with or without acute/chronic LBP. LBP is defined as pain or discomfort between costal margin and above the gluteal folds, with or without leg pain.
- All the included LBP participants must have modified Oswestry Disability Index score > 12%
- Have the ability to lie prone for at least 20 minutes.
- Asymptomatic participants should be free from LBP at the time of visit.
Exclusion Criteria:
- With medical 'red flag' conditions such as cancer, cauda equine syndrome, spinal infection, fracture or systemic disease
- History of arm surgery, shoulder or arm pain that may hinder the arm lifting in prone
- History of orthopedic or neurological surgery to the spine, pelvis or hips
- Inflammatory or active infective processes involving spine or shoulder
- Spondylolisthesis, ankylosing spondylitis, scoliosis of greater than 20 degrees (Cobb's angle)
- Pregnancy
- Osteoporosis
- Neurologic deficit or signs of nerve root compression
- Congenital spinal disorder (such as spina bifida),
- Participation in competitive sports more than 3 times per week
- History of spinal manipulation or lumbar multifidus stabilization exercise training within the past 4 weeks
- Additional exclusion criteria for asymptomatic participants include: back pain in the preceding year, or exceeding 1 week; missed at least 1 work day because of back pain; and consultation for a back problem.
Contacts and Locations| Contact: Gregory N Kawchuk, PhD, DC | 780-492-6891 | greg.kawchuk@ualberta.ca |
| Contact: Arnold YL Wong, MPhil, PT | 780-492-0563 | yulok@ualberta.ca |
| Canada, Alberta | |
| River Valley Health Clinic | Recruiting |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Contact: Arnold YL Wong, MPhil, PT 780-492-0563 yulok@ualberta.ca | |
| Sub-Investigator: Arnold YL Wong, MPhil, PT | |
| Principal Investigator: | Gregory N Kawchuk, PhD, DC | Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta |
More Information
No publications provided
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01761838 History of Changes |
| Other Study ID Numbers: | Pro00027069 |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by University of Alberta:
|
spinal manipulative therapy low back pain experimental pain |
spinal stiffness lumbar multifidus degeneration |
Additional relevant MeSH terms:
|
Asthenia Back Pain Low Back Pain Muscle Weakness Paresis Signs and Symptoms Pain |
Neurologic Manifestations Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013