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Completed

NCT Number: NCT03078114

Central Mechanism of Manual Therapy for Low Back Pain

The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kansas Medical Center, Kansas City, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of subacute low back pain
  • Ability to read and understand English

Exclusion criteria

  • Previous low back surgery
  • Severe structural spinal deformity
  • Neurological compromise resulting in current nerve root entrapment
  • Spinal cord compression
  • Tumor
  • Severe spinal instability
  • Severe osteoporosis
  • Psychiatric disease
  • Head trauma
  • Spinal infection
  • Known cardiovascular or metabolic disease
  • Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
  • Pregnancy
  • Mini-Mental State Examination score < 25
  • Body Mass Index (BMI) < 18 or > 30
  • Pain or paresthesia below the knees
  • Systemic illness known to affect sensation i.e. diabetes
  • Acute and/or chronic pain condition unrelated to LBP

Treatment and study plan

Spinal Manipulation

Other

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.

Placebo Spinal Manipulation

Other

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.

Primary outcomes

  1. Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing

    Time frame: Change from Pre-treatment to Post-treatment, 2 Weeks

    Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated.

Secondary outcomes

  1. Change in function measured using the Oswestry Disability Index (ODI)

    Time frame: Change from Baseline to Week 2

    Outcome will be measured using the Oswestry Disability Index (ODI). Subjects answer to questions. Their responses indicate no impact to great impact. Scores for each question range from 0 to 5. Total score for the ODI is 50. The higher the score, the greater level of disability/function.

  2. Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)

    Time frame: Change from Baseline to Week 2

    Outcome will be measured using the Numerical Pain Rating Scale (NPRS). Pain intensity will be assessed using an 11-point scale. Scores on the scale range from "0" indicating no pain, "1" slight pain, and "10" strongest imaginable pain.

  3. Change in Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Change from Baseline to Week 2

    The FABQ is completed by the subject. It determines the level of fear and avoidance about work and physical activity. The measure is comprised of two subscales: a four item physical activity subscale (FABQ-W), and a seven-item work subscale (FABQ-W). An elevated FABQ score is predictive of the development of chronic disability in low back pain (LBP) patients.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Chiropractic Mutual Insurance Company Foundation

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2017
Registry last updated
Mar 13, 2017

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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