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Completed

NCT Number: NCT01761838

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

River Valley Health Clinic

Edmonton, Alberta, T6G 2C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMT for low back pain patients

Other

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

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 SMT

Other

No treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. Fear Avoidance Beliefs Questionnaire

    Time frame: Baseline

    It assesses the fear avoidance behaviour of participants

  6. 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

  7. Global Rating Of Change

    Time frame: 1 week after baseline

    It measures the perceived change of body function from the first visit.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2013
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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