Clinical trial NCT04879394: Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients
Official title: Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients: Implications for a Personalized Treatment Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital de Braga
name: Clinical Academic Center (2CA-Braga)
First posted: 2021-05-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
timeFrame: 1 week post-intervention
measure: Pain intensity at 1 month as assessed by NRS
timeFrame: 1 month post-intervention
measure: Pain intensity at 3 months as assessed by NRS
timeFrame: 3 months post-intervention
measure: Pain intensity at 6 months as assessed by NRS
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)
timeFrame: 1 week post-intervention
measure: Pain interference at 1 month as assessed by the BPI
timeFrame: 1 month post-intervention
measure: Pain interference at 3 months as assessed by the BPI
timeFrame: 3 months post-intervention
measure: Pain interference at 6 months as assessed by the BPI
timeFrame: 6 months post-intervention
measure: Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)
timeFrame: 1 week post-intervention
measure: Functionality at 1 month as assessed by the ODI
timeFrame: 1 month post-intervention
measure: Functionality at 3 months as assessed by the ODI
timeFrame: 3 months post-intervention
measure: Functionality at 6 months as assessed by the ODI
timeFrame: 6 months post-intervention
measure: Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)
timeFrame: 1 week post-intervention
measure: Quality of life at 1 month as assessed by the EQ-5D-5L
timeFrame: 1 month post-intervention
measure: Quality of life at 3 months as assessed by the EQ-5D-5L
timeFrame: 3 months post-intervention
measure: Quality of life at 6 months as assessed by the EQ-5D-5L
timeFrame: 6 months post-intervention
measure: Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week post-intervention
measure: Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 month post-intervention
measure: Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months post-intervention
measure: Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months post-intervention
measure: Optimism at 1 week as assessed by the Life Orientation Test (LOT)
timeFrame: 1 week post-intervention
measure: Optimism at 1 month as assessed by LOT
timeFrame: 1 month post-intervention
measure: Optimism at 3 months as assessed by LOT
timeFrame: 3 months post-intervention
measure: Optimism at 6 months as assessed by LOT
timeFrame: 6 months post-intervention
measure: Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: 1 week post-intervention
measure: Pain catastrophizing at 1 month as assessed by PCS
timeFrame: 1 month post-intervention
measure: Pain catastrophizing at 3 months as assessed by PCS
timeFrame: 3 months post-intervention
measure: Pain catastrophizing at 6 months as assessed by PCS
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Hospital de Braga
Study officials:
affiliation: University of Minho
name: Patrícia R Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References: