NCT04388007

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

May 7, 2020

Last Update Submit

May 7, 2024

Conditions

Keywords

Back painSpinal manipulationCohort study

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Dosage

    during the intervention

  • Expectation (for improvement of pain and disability)

    at baseline (pre-intervention)

  • Socio-demographic factors

    at baseline(pre-intervention)

  • Tampa Scale of Kinesiophobia

    at baseline(pre-intervention)

  • Level of anxiety

    at baseline (pre-intervention)

  • +1 more secondary outcomes

Interventions

High velocity, low amplitude force manipulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are patient in the chiropractic care center

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Doctor of Chiropractic

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 14, 2020

Study Start

February 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations