Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

Low Back Pain Clinical Trial

Official title:

Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients: Implications for a Personalized Treatment Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879394
• Other study ID #: 2CA2019
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: University of Minho
• Contact: Patrícia R Pinto, PhD
• Phone: 00351253604926
• Email: patipinto[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.

Description:

Chronic low back pain (CLBP) is a very prevalent condition, associated with high disability and financial costs. Pain sensitization and psychological status have been associated with symptom severity and treatment outcomes, but their prognostic value is not yet well established.

This is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.

This work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• persistent or recurrent low back pain lasting over 3 months

Exclusion Criteria:

• pain due to other causes (e.g. fibromyalgia, fracture)

• back surgery in the previous 6 months or planned in the following 6 months

• debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)

• disability compensation or litigation related to CLBP

• unavailability to commit to the hypnosis sessions.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Hypnosis
4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.

Locations

Country	Name	City	State
Portugal	Hospital de Braga	Braga

Sponsors (3)

Lead Sponsor	Collaborator
University of Minho	Clinical Academic Center (2CA-Braga), Hospital de Braga

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)	Pain intensity assessed by NRS	1 week post-intervention
Primary	Pain intensity at 1 month as assessed by NRS	Pain intensity assessed by NRS	1 month post-intervention
Primary	Pain intensity at 3 months as assessed by NRS	Pain intensity assessed by NRS	3 months post-intervention
Primary	Pain intensity at 6 months as assessed by NRS	Pain intensity assessed by NRS	6 months post-intervention
Secondary	Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)	Pain interference assessed by the BPI	1 week post-intervention
Secondary	Pain interference at 1 month as assessed by the BPI	Pain interference assessed by the BPI	1 month post-intervention
Secondary	Pain interference at 3 months as assessed by the BPI	Pain interference assessed by the BPI	3 months post-intervention
Secondary	Pain interference at 6 months as assessed by the BPI	Pain interference assessed by the BPI	6 months post-intervention
Secondary	Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)	Functionality assessed by the ODI	1 week post-intervention
Secondary	Functionality at 1 month as assessed by the ODI	Functionality as assessed by the ODI	1 month post-intervention
Secondary	Functionality at 3 months as assessed by the ODI	Functionality assessed by the ODI	3 months post-intervention
Secondary	Functionality at 6 months as assessed by the ODI	Functionality assessed by the ODI	6 months post-intervention
Secondary	Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)	Quality of life assessed by the EQ-5D-5L	1 week post-intervention
Secondary	Quality of life at 1 month as assessed by the EQ-5D-5L	Quality of life assessed by the EQ-5D-5L	1 month post-intervention
Secondary	Quality of life at 3 months as assessed by the EQ-5D-5L	Quality of life assessed by the EQ-5D-5L	3 months post-intervention
Secondary	Quality of life at 6 months as assessed by the EQ-5D-5L	Quality of life assessed by the EQ-5D-5L	6 months post-intervention
Secondary	Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)	Emotional distress assessed by HADS	1 week post-intervention
Secondary	Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)	Emotional distress assessed by HADS	1 month post-intervention
Secondary	Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)	Emotional distress assessed by HADS	3 months post-intervention
Secondary	Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)	Emotional distress assessed by HADS	6 months post-intervention
Secondary	Optimism at 1 week as assessed by the Life Orientation Test (LOT)	Optimism assessed by LOT	1 week post-intervention
Secondary	Optimism at 1 month as assessed by LOT	Optimism assessed by LOT	1 month post-intervention
Secondary	Optimism at 3 months as assessed by LOT	Optimism assessed by LOT	3 months post-intervention
Secondary	Optimism at 6 months as assessed by LOT	Optimism assessed by LOT	6 months post-intervention
Secondary	Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)	Pain catastrophizing assessed by PCS	1 week post-intervention
Secondary	Pain catastrophizing at 1 month as assessed by PCS	Pain catastrophizing assessed by PCS	1 month post-intervention
Secondary	Pain catastrophizing at 3 months as assessed by PCS	Pain catastrophizing assessed by PCS	3 months post-intervention
Secondary	Pain catastrophizing at 6 months as assessed by PCS	Pain catastrophizing assessed by PCS	6 months post-intervention