Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

NCT ID: NCT04879394

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Hypnosis

Intervention Type OTHER

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Braga

OTHER

Sponsor Role collaborator

Clinical Academic Center (2CA-Braga)

OTHER

Sponsor Role collaborator

University of Minho

OTHER

Sponsor Role lead

Responsible Party

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Patrícia Ribeiro Pinto

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrícia R Pinto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minho

Locations

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Hospital de Braga

Braga, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Patrícia R Pinto, PhD

Role: CONTACT

00351253604926

Facility Contacts

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Joana Reis

Role: primary

+351 253 027 249

Other Identifiers

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2CA2019

Identifier Type: -

Identifier Source: org_study_id

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