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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
160
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.
Hospital de Braga
Braga, Portugal
RECRUITINGPain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Pain intensity assessed by NRS
Time frame: 1 week post-intervention
Pain intensity at 1 month as assessed by NRS
Pain intensity assessed by NRS
Time frame: 1 month post-intervention
Pain intensity at 3 months as assessed by NRS
Pain intensity assessed by NRS
Time frame: 3 months post-intervention
Pain intensity at 6 months as assessed by NRS
Pain intensity assessed by NRS
Time frame: 6 months post-intervention
Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)
Pain interference assessed by the BPI
Time frame: 1 week post-intervention
Pain interference at 1 month as assessed by the BPI
Pain interference assessed by the BPI
Time frame: 1 month post-intervention
Pain interference at 3 months as assessed by the BPI
Pain interference assessed by the BPI
Time frame: 3 months post-intervention
Pain interference at 6 months as assessed by the BPI
Pain interference assessed by the BPI
Time frame: 6 months post-intervention
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Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)
Functionality assessed by the ODI
Time frame: 1 week post-intervention
Functionality at 1 month as assessed by the ODI
Functionality as assessed by the ODI
Time frame: 1 month post-intervention
Functionality at 3 months as assessed by the ODI
Functionality assessed by the ODI
Time frame: 3 months post-intervention
Functionality at 6 months as assessed by the ODI
Functionality assessed by the ODI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post-intervention
Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Time frame: 1 week post-intervention
Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Time frame: 1 month post-intervention
Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Time frame: 3 months post-intervention
Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Time frame: 6 months post-intervention
Optimism at 1 week as assessed by the Life Orientation Test (LOT)
Optimism assessed by LOT
Time frame: 1 week post-intervention
Optimism at 1 month as assessed by LOT
Optimism assessed by LOT
Time frame: 1 month post-intervention
Optimism at 3 months as assessed by LOT
Optimism assessed by LOT
Time frame: 3 months post-intervention
Optimism at 6 months as assessed by LOT
Optimism assessed by LOT
Time frame: 6 months post-intervention
Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing assessed by PCS
Time frame: 1 week post-intervention
Pain catastrophizing at 1 month as assessed by PCS
Pain catastrophizing assessed by PCS
Time frame: 1 month post-intervention
Pain catastrophizing at 3 months as assessed by PCS
Pain catastrophizing assessed by PCS
Time frame: 3 months post-intervention
Pain catastrophizing at 6 months as assessed by PCS
Pain catastrophizing assessed by PCS
Time frame: 6 months post-intervention