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Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
University of Minho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital de BragaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypnosis

Control

Arm Description

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.

Receives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention.

Outcomes

Primary Outcome Measures

Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Pain intensity assessed by NRS
Pain intensity at 1 month as assessed by NRS
Pain intensity assessed by NRS
Pain intensity at 3 months as assessed by NRS
Pain intensity assessed by NRS
Pain intensity at 6 months as assessed by NRS
Pain intensity assessed by NRS

Secondary Outcome Measures

Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)
Pain interference assessed by the BPI
Pain interference at 1 month as assessed by the BPI
Pain interference assessed by the BPI
Pain interference at 3 months as assessed by the BPI
Pain interference assessed by the BPI
Pain interference at 6 months as assessed by the BPI
Pain interference assessed by the BPI
Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)
Functionality assessed by the ODI
Functionality at 1 month as assessed by the ODI
Functionality as assessed by the ODI
Functionality at 3 months as assessed by the ODI
Functionality assessed by the ODI
Functionality at 6 months as assessed by the ODI
Functionality assessed by the ODI
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
Quality of life at 1 month as assessed by the EQ-5D-5L
Quality of life assessed by the EQ-5D-5L
Quality of life at 3 months as assessed by the EQ-5D-5L
Quality of life assessed by the EQ-5D-5L
Quality of life at 6 months as assessed by the EQ-5D-5L
Quality of life assessed by the EQ-5D-5L
Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress assessed by HADS
Optimism at 1 week as assessed by the Life Orientation Test (LOT)
Optimism assessed by LOT
Optimism at 1 month as assessed by LOT
Optimism assessed by LOT
Optimism at 3 months as assessed by LOT
Optimism assessed by LOT
Optimism at 6 months as assessed by LOT
Optimism assessed by LOT
Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing assessed by PCS
Pain catastrophizing at 1 month as assessed by PCS
Pain catastrophizing assessed by PCS
Pain catastrophizing at 3 months as assessed by PCS
Pain catastrophizing assessed by PCS
Pain catastrophizing at 6 months as assessed by PCS
Pain catastrophizing assessed by PCS

Full Information

First Posted
May 4, 2021
Last Updated
May 18, 2022
Sponsor
University of Minho
Collaborators
Hospital de Braga, Clinical Academic Center (2CA-Braga)
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1. Study Identification

Unique Protocol Identification Number
NCT04879394
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho
Collaborators
Hospital de Braga, Clinical Academic Center (2CA-Braga)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receives standard care as usual. Assessments will be made in the same time points as experimental group, but without undergoing intervention.
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
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 Measure Information:
Title
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Description
Pain intensity assessed by NRS
Time Frame
1 week post-intervention
Title
Pain intensity at 1 month as assessed by NRS
Description
Pain intensity assessed by NRS
Time Frame
1 month post-intervention
Title
Pain intensity at 3 months as assessed by NRS
Description
Pain intensity assessed by NRS
Time Frame
3 months post-intervention
Title
Pain intensity at 6 months as assessed by NRS
Description
Pain intensity assessed by NRS
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)
Description
Pain interference assessed by the BPI
Time Frame
1 week post-intervention
Title
Pain interference at 1 month as assessed by the BPI
Description
Pain interference assessed by the BPI
Time Frame
1 month post-intervention
Title
Pain interference at 3 months as assessed by the BPI
Description
Pain interference assessed by the BPI
Time Frame
3 months post-intervention
Title
Pain interference at 6 months as assessed by the BPI
Description
Pain interference assessed by the BPI
Time Frame
6 months post-intervention
Title
Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)
Description
Functionality assessed by the ODI
Time Frame
1 week post-intervention
Title
Functionality at 1 month as assessed by the ODI
Description
Functionality as assessed by the ODI
Time Frame
1 month post-intervention
Title
Functionality at 3 months as assessed by the ODI
Description
Functionality assessed by the ODI
Time Frame
3 months post-intervention
Title
Functionality at 6 months as assessed by the ODI
Description
Functionality assessed by the ODI
Time Frame
6 months post-intervention
Title
Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)
Description
Quality of life assessed by the EQ-5D-5L
Time Frame
1 week post-intervention
Title
Quality of life at 1 month as assessed by the EQ-5D-5L
Description
Quality of life assessed by the EQ-5D-5L
Time Frame
1 month post-intervention
Title
Quality of life at 3 months as assessed by the EQ-5D-5L
Description
Quality of life assessed by the EQ-5D-5L
Time Frame
3 months post-intervention
Title
Quality of life at 6 months as assessed by the EQ-5D-5L
Description
Quality of life assessed by the EQ-5D-5L
Time Frame
6 months post-intervention
Title
Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
Emotional distress assessed by HADS
Time Frame
1 week post-intervention
Title
Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
Emotional distress assessed by HADS
Time Frame
1 month post-intervention
Title
Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
Emotional distress assessed by HADS
Time Frame
3 months post-intervention
Title
Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
Emotional distress assessed by HADS
Time Frame
6 months post-intervention
Title
Optimism at 1 week as assessed by the Life Orientation Test (LOT)
Description
Optimism assessed by LOT
Time Frame
1 week post-intervention
Title
Optimism at 1 month as assessed by LOT
Description
Optimism assessed by LOT
Time Frame
1 month post-intervention
Title
Optimism at 3 months as assessed by LOT
Description
Optimism assessed by LOT
Time Frame
3 months post-intervention
Title
Optimism at 6 months as assessed by LOT
Description
Optimism assessed by LOT
Time Frame
6 months post-intervention
Title
Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)
Description
Pain catastrophizing assessed by PCS
Time Frame
1 week post-intervention
Title
Pain catastrophizing at 1 month as assessed by PCS
Description
Pain catastrophizing assessed by PCS
Time Frame
1 month post-intervention
Title
Pain catastrophizing at 3 months as assessed by PCS
Description
Pain catastrophizing assessed by PCS
Time Frame
3 months post-intervention
Title
Pain catastrophizing at 6 months as assessed by PCS
Description
Pain catastrophizing assessed by PCS
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrícia R Pinto, PhD
Phone
00351253604926
Email
patipinto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia R Pinto, PhD
Organizational Affiliation
University of Minho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joana Reis
Phone
+351 253 027 249

12. IPD Sharing Statement

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Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

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