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

NCT ID: NCT01761838

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SMT for low back pain patients

Intervention Type: OTHER

High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.

Asymptomatic arm

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).

Group Type: OTHER

Pain induction (optional)

Intervention Type: OTHER

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.

Low back pain participants without SMT

To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT

Group Type: OTHER

Low back pain participants without SMT

Intervention Type: OTHER

No treatment

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Low back pain participants without SMT

No treatment

Intervention Type: OTHER

Other Intervention Names

High velocity, low amplitude spinal manipulative therapy; spinal manipulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory N Kawchuk, PhD, DC

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta

Locations

River Valley Health Clinic

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00027069

Identifier Type: -

Identifier Source: org_study_id