Skip to main content
OpenTrials
Completed

NCT Number: NCT04388007

Non-specific Back Pain and Spinal Manipulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-specific Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Thoracic Spinal Manipulation

Other

High velocity, low amplitude force manipulation

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Dosage

    Time frame: during the intervention

    assessed by a force-sensing table recording data through a computer software

  2. 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

  3. Socio-demographic factors

    Time frame: at baseline(pre-intervention)

    assessed with a patient history questionary

  4. Tampa Scale of Kinesiophobia

    Time frame: at baseline(pre-intervention)

    Questionary, Total score range from 17 to 68, Higher score indicate a worst outcome

  5. 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)

  6. Level of Comfort

    Time frame: at baseline (post-intervention)

    Assessed with a 100mm scale : higher score means very comfortable

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 14, 2020
Registry last updated
May 8, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.