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

Primary Purpose

Low Back Pain, Degeneration of Lumbosacral Intervertebral Disc, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMT for low back pain patients
Pain induction (optional)
Low back pain participants without SMT
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring spinal manipulative therapy, low back pain, experimental pain, spinal stiffness, lumbar multifidus, degeneration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • River Valley Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

SMT for low back pain patients

Asymptomatic arm

Low back pain participants without SMT

Arm Description

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

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).

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

Outcomes

Primary Outcome Measures

Change of Modified Oswestry Low Back Pain Disability Index
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Change of 11-point Numeric Pain Rating Scale
It is a scale to measure the perceived pain intensity by the participants.
Change in Body Pain diagram
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
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
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
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
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).
Fear Avoidance Beliefs Questionnaire
It assesses the fear avoidance behaviour of participants
Change in Borg Category-Ratio Scale of Perceived Exertion
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Global Rating Of Change
It measures the perceived change of body function from the first visit.

Full Information

First Posted
January 2, 2013
Last Updated
August 9, 2015
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01761838
Brief Title
The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
Official Title
The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Degeneration of Lumbosacral Intervertebral Disc, Muscle Weakness, Spine Stiffness
Keywords
spinal manipulative therapy, low back pain, experimental pain, spinal stiffness, lumbar multifidus, degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMT for low back pain patients
Arm Type
Experimental
Arm Description
To investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity.
Arm Title
Asymptomatic arm
Arm Type
Other
Arm Description
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).
Arm Title
Low back pain participants without SMT
Arm Type
Other
Arm Description
To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT
Intervention Type
Other
Intervention Name(s)
SMT for low back pain patients
Other Intervention Name(s)
High velocity, low amplitude spinal manipulative therapy, spinal manipulation
Intervention Description
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
Intervention Type
Other
Intervention Name(s)
Pain induction (optional)
Intervention Description
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
Intervention Name(s)
Low back pain participants without SMT
Intervention Description
No treatment
Primary Outcome Measure Information:
Title
Change of Modified Oswestry Low Back Pain Disability Index
Description
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Time Frame
baseline, Day 3, and 1 week
Title
Change of 11-point Numeric Pain Rating Scale
Description
It is a scale to measure the perceived pain intensity by the participants.
Time Frame
baseline, Day 3, and 1 week
Title
Change in Body Pain diagram
Description
The diagram will be used to demarcate the location and area of symptoms
Time Frame
Baseline, Day 3, and 1 week
Secondary Outcome Measure Information:
Title
Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging
Description
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
Time Frame
Baseline, Day 3, and 1 week
Title
Change of spinal stiffness testing by a mechanical indentation machine
Description
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.
Time Frame
Baseline, Day 3, and 1 week
Title
Electromyography of trunk muscles
Description
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
Time Frame
At the third visit (1 week from the baseline)
Title
Magnetic resonance imaging of lumbar region for participants with low back pain
Description
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).
Time Frame
At the beginning and immediately after the first visit (an expected average of 1 hour apart)
Title
Fear Avoidance Beliefs Questionnaire
Description
It assesses the fear avoidance behaviour of participants
Time Frame
Baseline
Title
Change in Borg Category-Ratio Scale of Perceived Exertion
Description
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Time Frame
Baseline, Day 3, and 1 week
Title
Global Rating Of Change
Description
It measures the perceived change of body function from the first visit.
Time Frame
1 week after baseline
Other Pre-specified Outcome Measures:
Title
Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment
Description
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Title
Spinal stiffness assessment by mechanical indentation machine in the pain induction experiment
Description
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.
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Title
Electromyography of trunk muscles in the pain induction experiment
Description
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Title
11-point Numeric Pain Rating Scale in the pain induction experiment
Description
It is a scale to measure the perceived pain intensity by the participants.
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Title
Body Pain diagram in the pain induction experiment
Description
The diagram will be used to demarcate the location and area of symptoms
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session
Title
Modified Oswestry low back pain disability index in the pain induction experiment
Description
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Time Frame
Before the injection in each session
Title
Fear of Pain Questionnaire - III in the pain induction experiment
Description
It measures the perceived fear of pain under different hypothetical painful experiences.
Time Frame
Before the injection in the first session
Title
Fear Avoidance Beliefs Questionnaire in the pain induction experiment
Description
It assesses the fear avoidance behaviour of participants
Time Frame
Before the injection in the first session
Title
Borg Category-Ratio Scale of Perceived Exertion in the pain induction experiment
Description
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Time Frame
Before the injection, immediately after the injection, and 25-minute after the injection in each session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory N Kawchuk, PhD, DC
Organizational Affiliation
Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
River Valley Health Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada

12. IPD Sharing Statement

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

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