Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

University of Minho

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04879394

2CA2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Hypnosis

Experimental group

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.

Treatment:

Other: Hypnosis

Control

No Intervention group

Description:

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