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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761838
• Other study ID #: Pro00027069
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: August 9, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• Low back pain participants without SMT
No treatment

Locations

Country	Name	City	State
Canada	River Valley Health Clinic	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment	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	No
Other	Spinal stiffness assessment by mechanical indentation machine in the pain induction experiment	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	No
Other	Electromyography of trunk muscles in the pain induction experiment	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	No
Other	11-point Numeric Pain Rating Scale in the pain induction experiment	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	No
Other	Body Pain diagram in the pain induction experiment	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	No
Other	Modified Oswestry low back pain disability index in the pain induction experiment	It is a questionnaire to assess the participants' perceived low back pain related functional disability.	Before the injection in each session	No
Other	Fear of Pain Questionnaire - III in the pain induction experiment	It measures the perceived fear of pain under different hypothetical painful experiences.	Before the injection in the first session	No
Other	Fear Avoidance Beliefs Questionnaire in the pain induction experiment	It assesses the fear avoidance behaviour of participants	Before the injection in the first session	No
Other	Borg Category-Ratio Scale of Perceived Exertion in the pain induction experiment	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	No
Primary	Change of Modified Oswestry Low Back Pain Disability Index	It is a questionnaire to assess the participants' perceived low back pain related functional disability.	baseline, Day 3, and 1 week	No
Primary	Change of 11-point Numeric Pain Rating Scale	It is a scale to measure the perceived pain intensity by the participants.	baseline, Day 3, and 1 week	No
Primary	Change in Body Pain diagram	The diagram will be used to demarcate the location and area of symptoms	Baseline, Day 3, and 1 week	No
Secondary	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.	Baseline, Day 3, and 1 week	No
Secondary	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.	Baseline, Day 3, and 1 week	No
Secondary	Electromyography of trunk muscles	Electromyography of abdominal and erector spinae muscles during spinal stiffness testing will be measured.	At the third visit (1 week from the baseline)	No
Secondary	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).	At the beginning and immediately after the first visit (an expected average of 1 hour apart)	No
Secondary	Fear Avoidance Beliefs Questionnaire	It assesses the fear avoidance behaviour of participants	Baseline	No
Secondary	Change in Borg Category-Ratio Scale of Perceived Exertion	It measures the subjective perception of exertion during the spinal stiffness test and muscle testings	Baseline, Day 3, and 1 week	No
Secondary	Global Rating Of Change	It measures the perceived change of body function from the first visit.	1 week after baseline	No