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Low Back Pain | The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures

Low Back Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Low Back Pain

Degeneration of Lumbosacral Intervertebral Disc

Muscle Weakness

Spine Stiffness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:SMT for low back pain patientsHigh velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.

Other:Pain induction (optional)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.

Other:Low back pain participants without SMTNo treatment

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SMT for low back pain patientsTo investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity.

Asymptomatic armTo 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).

Low back pain participants without SMTTo investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT

Study Status

Completed

Start Date: January 2013

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change of Modified Oswestry Low Back Pain Disability Index

Secondary Outcome: Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging

Study sponsors, principal investigator, and references

Principal Investigator: Gregory N Kawchuk, PhD, DC

Lead Sponsor: University of Alberta

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01761838

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