Non-specific Back Pain and Spinal Manipulation

Overview

The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors.

Full Title of Study: “Predictors for Identifying Patients With Non-specific Back Pain Who Respond Favorably to Spinal Manipulation: a Prospective Cohort Study”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2021

Detailed Description

The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated at baseline and at 7 days. Pain score will be also assessed every day with text-tracking. Global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors. 100 individuals with a history of non-specific back pain will be recruited in a chiropractic care center.

Interventions

  • Other: Thoracic spinal manipulation
    • High velocity, low amplitude force manipulation

Clinical Trial Outcome Measures

Primary Measures

  • Thoracic Back Pain (Numerical Analog Scale)
    • Time Frame: change from baseline to Day-7
    • assessed by a 0-10 points scale, higher score means altered, lower score means improved
  • Functional Disability (Quebec Back Pain Disability Scale)
    • Time Frame: change from baseline to Day-7
    • assessed by 0-100 points questionary. Higher scores correlate to greater disability
  • Global Perceived Change Scale
    • Time Frame: at day-7
    • assessed by a 11-point score scale: higher score means improved, lower score means altered

Secondary Measures

  • Dosage
    • Time Frame: during the intervention
    • assessed by a force-sensing table recording data through a computer software
  • Expectation (for improvement of pain and disability)
    • Time Frame: at baseline (pre-intervention)
    • assessed by a 11-point score scale : higher score means improved, lower score means altered
  • Socio-demographic factors
    • Time Frame: at baseline(pre-intervention)
    • assessed with a patient history questionary
  • Tampa Scale of Kinesiophobia
    • Time Frame: at baseline(pre-intervention)
    • Questionary, Total score range from 17 to 68, Higher score indicate a worst outcome
  • Level of anxiety
    • Time Frame: at baseline (pre-intervention)
    • Assessed using the State-Trait Anxiety Inventory (STAI) (score range from 20 (minimum) to 80 (maximum) : higher score mean a worst outcome)
  • Level of Comfort
    • Time Frame: at baseline (post-intervention)
    • Assessed with a 100mm scale : higher score means very comfortable

Participating in This Clinical Trial

Inclusion Criteria

  • Being aged over 18 years old – Presenting non-specific back pain (chronic >=3 months or recurrent complaint) – Speaking French or English Exclusion Criteria:

  • Symptomatic thoracic pain – Non-musculoskeletal disorders pain – Pregnancy – Not eligible to spinal manipulation (if osteoporosis, vertebral fracture history, thoracic disk herniation)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Université du Québec à Trois-Rivières
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin Descarreaux, Professor, Doctor of Chiropractic – Université du Québec à Trois-Rivières
  • Overall Official(s)
    • Martin Descarreaux, DC, PhD, Study Director, Université du Québec à Trois-Rivières
  • Overall Contact(s)
    • Martin Descarreaux, DC, PhD, 819 376-5011, martin.descarreaux@uqtr.ca

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