Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Hypnosis


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br>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. | Other: Hypnosis<br>* 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.<br>|
| No Intervention: Control<br>Receives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS) | Pain intensity assessed by NRS | 1 week post-intervention | 
| Pain intensity at 1 month as assessed by NRS | Pain intensity assessed by NRS | 1 month post-intervention | 
| Pain intensity at 3 months as assessed by NRS | Pain intensity assessed by NRS | 3 months post-intervention | 
| Pain intensity at 6 months as assessed by NRS | Pain intensity assessed by NRS | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI) | Pain interference assessed by the BPI | 1 week post-intervention | 
| Pain interference at 1 month as assessed by the BPI | Pain interference assessed by the BPI | 1 month post-intervention | 
| Pain interference at 3 months as assessed by the BPI | Pain interference assessed by the BPI | 3 months post-intervention | 
| Pain interference at 6 months as assessed by the BPI | Pain interference assessed by the BPI | 6 months post-intervention | 
| Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI) | Functionality assessed by the ODI | 1 week post-intervention | 
| Functionality at 1 month as assessed by the ODI | Functionality as assessed by the ODI | 1 month post-intervention | 
| Functionality at 3 months as assessed by the ODI | Functionality assessed by the ODI | 3 months post-intervention | 
| Functionality at 6 months as assessed by the ODI | Functionality assessed by the ODI | 6 months post-intervention | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS) | Emotional distress assessed by HADS | 1 week post-intervention | 
| Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS) | Emotional distress assessed by HADS | 1 month post-intervention | 
| Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS) | Emotional distress assessed by HADS | 3 months post-intervention | 
| Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS) | Emotional distress assessed by HADS | 6 months post-intervention | 
| Optimism at 1 week as assessed by the Life Orientation Test (LOT) | Optimism assessed by LOT | 1 week post-intervention | 
| Optimism at 1 month as assessed by LOT | Optimism assessed by LOT | 1 month post-intervention | 
| Optimism at 3 months as assessed by LOT | Optimism assessed by LOT | 3 months post-intervention | 
| Optimism at 6 months as assessed by LOT | Optimism assessed by LOT | 6 months post-intervention | 
| Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS) | Pain catastrophizing assessed by PCS | 1 week post-intervention | 
| Pain catastrophizing at 1 month as assessed by PCS | Pain catastrophizing assessed by PCS | 1 month post-intervention | 
| Pain catastrophizing at 3 months as assessed by PCS | Pain catastrophizing assessed by PCS | 3 months post-intervention | 
| Pain catastrophizing at 6 months as assessed by PCS | Pain catastrophizing assessed by PCS | 6 months post-intervention |