Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Hypnosis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrícia R Pinto, PhD; Phone Number: 00351253604926; Email: patipinto@gmail.com

Study Locations

• Portugal
  • Braga, Portugal, 4710
    • Recruiting
    • Hospital de Braga
    • Contact: Joana Reis; Phone Number: +351 253 027 249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; 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

Collaborators and Investigators

• Sponsor: University of Minho
• Collaborators: Hospital de Braga; Clinical Academic Center (2CA-Braga)
• Investigators: Principal Investigator: Patrícia R Pinto, PhD, University of Minho

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2CA2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No