The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
- Conditions
- Muscle WeaknessLow Back PainDegeneration of Lumbosacral Intervertebral DiscSpine Stiffness
- Interventions
- Other: Low back pain participants without SMTOther: SMT for low back pain patientsOther: Pain induction (optional)
- Registration Number
- NCT01761838
- Lead Sponsor
- University of Alberta
- Brief Summary
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.
- 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/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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low back pain participants without SMT Low back pain participants without SMT To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT SMT for low back pain patients 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. Asymptomatic arm Pain induction (optional) 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).
- Primary Outcome Measures
Name Time Method Change of Modified Oswestry Low Back Pain Disability Index baseline, Day 3, and 1 week It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Change of 11-point Numeric Pain Rating Scale baseline, Day 3, and 1 week It is a scale to measure the perceived pain intensity by the participants.
Change in Body Pain diagram Baseline, Day 3, and 1 week The diagram will be used to demarcate the location and area of symptoms
- Secondary Outcome Measures
Name Time Method Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging 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.
Change of spinal stiffness testing by a mechanical indentation machine 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.
Electromyography of trunk muscles At the third visit (1 week from the baseline) Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
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) 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).
Change in Borg Category-Ratio Scale of Perceived Exertion Baseline, Day 3, and 1 week It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Global Rating Of Change 1 week after baseline It measures the perceived change of body function from the first visit.
Fear Avoidance Beliefs Questionnaire Baseline It assesses the fear avoidance behaviour of participants
Trial Locations
- Locations (1)
River Valley Health Clinic
🇨🇦Edmonton, Alberta, Canada