NCT04879394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started May 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 4, 2021

Last Update Submit

May 18, 2022

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (24)

  • Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)

    1 week post-intervention

  • Pain interference at 1 month as assessed by the BPI

    1 month post-intervention

  • Pain interference at 3 months as assessed by the BPI

    3 months post-intervention

  • Pain interference at 6 months as assessed by the BPI

    6 months post-intervention

  • Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)

    1 week post-intervention

  • +19 more secondary outcomes

Study Arms (2)

Hypnosis

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

HypnosisOTHER

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.

Hypnosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persistent or recurrent low back pain lasting over 3 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Braga

Braga, 4710, Portugal

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Patrícia R Pinto, PhD

    University of Minho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia R Pinto, PhD

CONTACT

00351253604926patipinto@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 10, 2021

Study Start

May 16, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

PT(1)