Clinical trial NCT04388007: Non-specific Back Pain and Spinal Manipulation
Official title: Predictors for Identifying Patients With Non-specific Back Pain Who Respond Favorably to Spinal Manipulation: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-specific Back Pain
Keywords: Back pain
Spinal manipulation
Cohort study
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are patient in the chiropractic care center

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Thoracic Back Pain (Numerical Analog Scale)
timeFrame: change from baseline to Day-7
measure: Functional Disability (Quebec Back Pain Disability Scale)
timeFrame: change from baseline to Day-7
measure: Global Perceived Change Scale
timeFrame: at day-7
Secondary outcomes:
measure: Dosage
timeFrame: during the intervention
measure: Expectation (for improvement of pain and disability)
timeFrame: at baseline (pre-intervention)
measure: Socio-demographic factors
timeFrame: at baseline(pre-intervention)
measure: Tampa Scale of Kinesiophobia
timeFrame: at baseline(pre-intervention)
measure: Level of anxiety
timeFrame: at baseline (pre-intervention)
measure: Level of Comfort
timeFrame: at baseline (post-intervention)
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: STUDY_DIRECTOR
References: