- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761838
The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2C8
- River Valley Health Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
Other Names:
|
Other: 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).
|
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
To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT
|
No treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Modified Oswestry Low Back Pain Disability Index
Time Frame: baseline, Day 3, and 1 week
|
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
|
baseline, Day 3, and 1 week
|
Change of 11-point Numeric Pain Rating Scale
Time Frame: baseline, Day 3, and 1 week
|
It is a scale to measure the perceived pain intensity by the participants.
|
baseline, Day 3, and 1 week
|
Change in Body Pain diagram
Time Frame: Baseline, Day 3, and 1 week
|
The diagram will be used to demarcate the location and area of symptoms
|
Baseline, Day 3, and 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging
Time Frame: Baseline, Day 3, and 1 week
|
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
|
Baseline, Day 3, and 1 week
|
Change of spinal stiffness testing by a mechanical indentation machine
Time Frame: Baseline, Day 3, and 1 week
|
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.
|
Baseline, Day 3, and 1 week
|
Electromyography of trunk muscles
Time Frame: At the third visit (1 week from the baseline)
|
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
|
At the third visit (1 week from the baseline)
|
Magnetic resonance imaging of lumbar region for participants with low back pain
Time Frame: At the beginning and immediately after the first visit (an expected average of 1 hour apart)
|
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).
|
At the beginning and immediately after the first visit (an expected average of 1 hour apart)
|
Fear Avoidance Beliefs Questionnaire
Time Frame: Baseline
|
It assesses the fear avoidance behaviour of participants
|
Baseline
|
Change in Borg Category-Ratio Scale of Perceived Exertion
Time Frame: Baseline, Day 3, and 1 week
|
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
|
Baseline, Day 3, and 1 week
|
Global Rating Of Change
Time Frame: 1 week after baseline
|
It measures the perceived change of body function from the first visit.
|
1 week after baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Using the rehabilitative ultrasound imaging to measure lumbar multifidus muscle thickness at rest and during an automatic muscle contraction.
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Spinal stiffness assessment by mechanical indentation machine in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
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.
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Electromyography of trunk muscles in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
11-point Numeric Pain Rating Scale in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
It is a scale to measure the perceived pain intensity by the participants.
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Body Pain diagram in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
The diagram will be used to demarcate the location and area of symptoms
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Modified Oswestry low back pain disability index in the pain induction experiment
Time Frame: Before the injection in each session
|
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
|
Before the injection in each session
|
Fear of Pain Questionnaire - III in the pain induction experiment
Time Frame: Before the injection in the first session
|
It measures the perceived fear of pain under different hypothetical painful experiences.
|
Before the injection in the first session
|
Fear Avoidance Beliefs Questionnaire in the pain induction experiment
Time Frame: Before the injection in the first session
|
It assesses the fear avoidance behaviour of participants
|
Before the injection in the first session
|
Borg Category-Ratio Scale of Perceived Exertion in the pain induction experiment
Time Frame: Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
|
Before the injection, immediately after the injection, and 25-minute after the injection in each session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory N Kawchuk, PhD, DC, Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00027069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on SMT for low back pain patients
-
Peking University People's HospitalUnknown
-
National Center for Complementary and Integrative...Completed
-
Hasselt UniversityKU Leuven; Université Catholique de Louvain; Universiteit Antwerpen; Axxon - the... and other collaboratorsRecruiting
-
Universidad Católica San Antonio de MurciaCompletedLow Back Pain | Postural; Strain
-
Vrije Universiteit BrusselCompletedLow Back Pain | Central Sensitisation | Sensory Profiles | Nociplastic PainBelgium
-
University of SalfordCompletedLow Back Pain | Chronic Pain | Muscle TightnessUnited Kingdom
-
University of SaskatchewanSaskatchewan Health Research Foundation; Ralston Brothers Grant (Kelsey Trail...Completed
-
Riphah International UniversityCompletedChronic Non Specific Low Back PainPakistan
-
Universidad Complutense de MadridNot yet recruiting
-
Aalborg University HospitalSpine Centre of Southern DenmarkRecruiting