Non-specific Back Pain and Spinal Manipulation

Predictors for Identifying Patients With Non-specific Back Pain Who Respond Favorably to Spinal Manipulation: a Prospective Cohort 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 using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors.

Study Overview

• Status: Completed
• Conditions: Non-specific Back Pain
• Intervention / Treatment: Other: Thoracic spinal manipulation

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8Z 4M3
      • Université du Québec à Trois-Rivières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are patient in the chiropractic care center

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières
• Investigators: Study Director: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cohort study; Back pain; Spinal manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: UQTR-2020-SMTdose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No