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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01761838
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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:
  • High velocity, low amplitude spinal manipulative therapy
  • spinal manipulation
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
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761838

Contacts
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

Locations
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         
Sponsors and Collaborators
University of Alberta
Investigators
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 August 26, 2014