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

NCT01761838 | Completed

• 1 other identifier: Pro00027069
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in Body Pain diagram

  The diagram will be used to demarcate the location and area of symptoms

  Baseline, Day 3, and 1 week

Secondary Outcomes (7)

• Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging

  Baseline, Day 3, and 1 week

• Change of spinal stiffness testing by a mechanical indentation machine

  Baseline, Day 3, and 1 week

• Electromyography of trunk muscles

  At the third visit (1 week from the baseline)

• Magnetic resonance imaging of lumbar region for participants with low back pain

  At the beginning and immediately after the first visit (an expected average of 1 hour apart)

• Fear Avoidance Beliefs Questionnaire

  Baseline

Other Outcomes (9)

• Measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging in the pain induction experiment

  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

  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

  Before the injection, immediately after the injection, and 25-minute after the injection in each session

Study Arms (3)

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.

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).

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

Other: Low back pain participants without SMT

Interventions

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.

Also known as: High velocity, low amplitude spinal manipulative therapy, spinal manipulation

SMT for low back pain patients

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.

Asymptomatic arm

Low back pain participants without SMT OTHER

No treatment

Low back pain participants without SMT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

River Valley Health Clinic

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Low Back Pain; Muscle Weakness

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Gregory N Kawchuk, PhD, DC

  Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 7, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CA (1)