Non-specific Back Pain and Spinal Manipulation

Non-specific Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388007
• Other study ID #: UQTR-2020-SMTdose
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2024
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Non-specific Back Pain

Intervention

Other:
• Thoracic spinal manipulation
High velocity, low amplitude force manipulation

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Global Perceived Change Scale	assessed by a 11-point score scale: higher score means improved, lower score means altered	at day-7
Secondary	Dosage	assessed by a force-sensing table recording data through a computer software	during the intervention
Secondary	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)
Secondary	Socio-demographic factors	assessed with a patient history questionary	at baseline(pre-intervention)
Secondary	Tampa Scale of Kinesiophobia	Questionary, Total score range from 17 to 68, Higher score indicate a worst outcome	at baseline(pre-intervention)
Secondary	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)
Secondary	Level of Comfort	Assessed with a 100mm scale : higher score means very comfortable	at baseline (post-intervention)