Low Back PainNCT01761838
The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
A study testing SMT for low back pain patients, Pain induction (optional) and Low back pain participants without SMT in people with Low Back Pain and Degeneration of Lumbosacral Intervertebral Disc, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Degeneration of Lumbosacral Intervertebral Disc, Muscle Weakness
- What is being tested?
- SMT for low back pain patients, Pain induction (optional) and Low back pain participants without SMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- SMT for low back pain patients, Pain induction (optional), Low back pain participants without SMT
- Keywords
- spinal manipulative therapy, low back pain, experimental pain, spinal stiffness, lumbar multifidus, degeneration
- Medical subject headings
- Low Back Pain, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMT for low back pain patientsOther
Also called High velocity, low amplitude spinal manipulative therapy, spinal manipulation
High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
Pain induction (optional)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 SMTOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| SMT for low back pain patients | Experimental | To investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity. Receives: Other: SMT for low back pain patients |
| Asymptomatic arm | Other | 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). Receives: Other: Pain induction (optional) |
| Low back pain participants without SMT | Other | To investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT Receives: Other: Low back pain participants without SMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Modified Oswestry Low Back Pain Disability Index
It is a questionnaire to assess the participants' perceived low back pain related functional disability.
Measured: baseline, Day 3, and 1 week
Change of 11-point Numeric Pain Rating Scale
It is a scale to measure the perceived pain intensity by the participants.
Measured: baseline, Day 3, and 1 week
Change in Body Pain diagram
The diagram will be used to demarcate the location and area of symptoms
Measured: Baseline, Day 3, and 1 week
Secondary outcomes (7)
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.
Measured: Baseline, Day 3, and 1 week
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.
Measured: Baseline, Day 3, and 1 week
Electromyography of trunk muscles
Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.
Measured: At the third visit (1 week from the baseline)
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).
Measured: At the beginning and immediately after the first visit (an expected average of 1 hour apart)
Fear Avoidance Beliefs Questionnaire
It assesses the fear avoidance behaviour of participants
Measured: Baseline
Change in Borg Category-Ratio Scale of Perceived Exertion
It measures the subjective perception of exertion during the spinal stiffness test and muscle testings
Measured: Baseline, Day 3, and 1 week
Global Rating Of Change
It measures the perceived change of body function from the first visit.
Measured: 1 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory N Kawchuk, PhD, DC, Principal investigator, Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761838
- Sponsor's protocol ID
- Pro00027069
- Status last verified
- Aug 2015
- First submitted
- 2 Jan 2013
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures
- ClinicalTrials.gov ID
- NCT01761838
- Acronym / sponsor ID
- Pro00027069
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SMT for low back pain patients | Experimental | Other: SMT for low back pain patientsTo investigate the effects of high velocity, low amplitude lumbopelvic spinal manipulative therapy on spinal stiffness and back muscle activity. |
| Asymptomatic arm | Other | Other: Pain induction (optional)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). |
| Low back pain participants without SMT | Other | Other: Low back pain participants without SMTTo investigate the temporal changes in lumbar disc diffusion within a 1-hour period without SMT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMT for low back pain patientsAlso: High velocity, low amplitude spinal manipulative therapy, spinal manipulationHigh velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides. | Other | SMT for low back pain patients |
| 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 | Asymptomatic arm |
| Low back pain participants without SMTNo treatment | Other | Low back pain participants without SMT |
Primary outcome
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.
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.
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
7 secondary outcomes
Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging
Time frame: Baseline, Day 3, and 1 week
Change of spinal stiffness testing by a mechanical indentation machine
Time frame: Baseline, Day 3, and 1 week
Electromyography of trunk muscles
Time frame: 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)
Fear Avoidance Beliefs Questionnaire
Time frame: Baseline
Change in Borg Category-Ratio Scale of Perceived Exertion
Time frame: Baseline, Day 3, and 1 week
Global Rating Of Change
Time frame: 1 week after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory N Kawchuk, PhD, DC principal investigator
Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT for low back pain patients, Pain induction (optional) and Low back pain participants without SMT in people with Low Back Pain and Degeneration of Lumbosacral Intervertebral Disc, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Modified Oswestry Low Back Pain Disability Index (time frame: baseline, Day 3, and 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.