Non-specific Back Pain and Spinal Manipulation

Completed

• Conditions: Non-specific Back Pain

• Registration Number: NCT04388007
• Lead Sponsor: Université du Québec à Trois-Rivières

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Université du Québec à Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada