Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients
- Conditions
- Low Back Pain
- Interventions
- Other: Hypnosis
- Registration Number
- NCT04879394
- Lead Sponsor
- University of Minho
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- persistent or recurrent low back pain lasting over 3 months
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis 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.
- Primary Outcome Measures
Name Time Method Pain intensity at 1 month as assessed by NRS 1 month post-intervention Pain intensity assessed by NRS
Pain intensity at 3 months as assessed by NRS 3 months post-intervention Pain intensity assessed by NRS
Pain intensity at 6 months as assessed by NRS 6 months post-intervention Pain intensity assessed by NRS
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS) 1 week post-intervention Pain intensity assessed by NRS
- Secondary Outcome Measures
Name Time Method Optimism at 1 month as assessed by LOT 1 month post-intervention Optimism assessed by LOT
Functionality at 1 month as assessed by the ODI 1 month post-intervention Functionality as assessed by the ODI
Functionality at 6 months as assessed by the ODI 6 months post-intervention Functionality assessed by the ODI
Pain interference at 6 months as assessed by the BPI 6 months post-intervention Pain interference assessed by the BPI
Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI) 1 week post-intervention Functionality assessed by the ODI
Functionality at 3 months as assessed by the ODI 3 months post-intervention Functionality assessed by the ODI
Quality of life at 3 months as assessed by the EQ-5D-5L 3 months post-intervention Quality of life assessed by the EQ-5D-5L
Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS) 6 months post-intervention Emotional distress assessed by HADS
Optimism at 3 months as assessed by LOT 3 months post-intervention Optimism assessed by LOT
Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS) 1 week post-intervention Pain catastrophizing assessed by PCS
Pain catastrophizing at 1 month as assessed by PCS 1 month post-intervention Pain catastrophizing assessed by PCS
Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI) 1 week post-intervention Pain interference assessed by the BPI
Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L) 1 week post-intervention Quality of life assessed by the EQ-5D-5L
Quality of life at 6 months as assessed by the EQ-5D-5L 6 months post-intervention Quality of life assessed by the EQ-5D-5L
Optimism at 1 week as assessed by the Life Orientation Test (LOT) 1 week post-intervention Optimism assessed by LOT
Optimism at 6 months as assessed by LOT 6 months post-intervention Optimism assessed by LOT
Pain interference at 1 month as assessed by the BPI 1 month post-intervention Pain interference assessed by the BPI
Pain interference at 3 months as assessed by the BPI 3 months post-intervention Pain interference assessed by the BPI
Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS) 1 week post-intervention Emotional distress assessed by HADS
Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS) 1 month post-intervention Emotional distress assessed by HADS
Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS) 3 months post-intervention Emotional distress assessed by HADS
Quality of life at 1 month as assessed by the EQ-5D-5L 1 month post-intervention Quality of life assessed by the EQ-5D-5L
Pain catastrophizing at 6 months as assessed by PCS 6 months post-intervention Pain catastrophizing assessed by PCS
Pain catastrophizing at 3 months as assessed by PCS 3 months post-intervention Pain catastrophizing assessed by PCS
Trial Locations
- Locations (1)
Hospital de Braga
🇵🇹Braga, Portugal