NCT01761838

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Low Back Pain
• Degeneration of Lumbosacral Intervertebral Disc
• Muscle Weakness
• Spine Stiffness

Interventions

Type	Name	Description
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	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 SMT	No treatment

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-01-07
• Last updated: 2015-08-11

Locations

1 site across 1 country: Canada