Clinical Trials Directory

Trials / Completed

CompletedNCT02638753

Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Universidade Cidade de Sao Paulo · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Although education on neurophysiology of pain improves disability, there are limited effects in pain intensity. Hypnosis is an approach that has proven useful in pain intensity and psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of its contribution in patients with chronic non specific low back pain. The aim of the study is to assess the efficacy of combining education on neurophysiology of pain and hypnosis in patients with chronic non specific low back pain in pain and disability outcomes.

Detailed description

Introduction: Education on pain neurophysiology has beneficial effects on disability and psychosocial aspects in patients with non specific chronic low back pain. However, education has limited effects in pain. Hypnosis is an approach that has proven efficient in pain intensity and psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of its contribution in patients with non specific chronic low back pain. Objectives: The aim of the study is to assess the efficacy of combining education on neurophysiology of pain and hypnosis in patients with non specific chronic low back pain in pain and disability outcomes. Study design: randomized controlled trial with two arms and blinded evaluator. Local study: Interventions will be held at the Universidade Cidade de Sao Paulo (UNICID). Participants: One hundred patients with chronic non specific low back pain who are on the waiting list for physical therapy care at UNICID physical therapy clinic, interested and eligible for the study will be invited to participate. Intervention: Patients will be randomized to the education group about pain neurophysiology or to a group that combines education with hypnosis. Measurements: Clinical outcomes will be obtained after 2 weeks and 3 months after randomization. The primary outcome will be pain intensity (measured by the numerical pain scale) and general disability (measured by the Roland-Morris questionnaire). The secondary outcome will be catastrophic thoughts (measured by PCS-Brazil), specific disability (measured by the Patient-specific function scale) and global perceived effect (measured by the Global Perceived Effect scale). Limitations: Both the therapist and the patients will not be blinded to the intervention provided. Hypothesis: This is the first study that will provided results achieved by education about pain neurophysiology using hypnosis in patients with chronic non specific low back pain.

Conditions

Interventions

TypeNameDescription
OTHEReducationPatients will be educated about pain neurophysiology.
OTHEReducation combined with hypnosisPatients will be educated about pain neurophysiology combined with hypnosis.

Timeline

Start date
2016-01-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2015-12-23
Last updated
2017-08-04

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02638753. Inclusion in this directory is not an endorsement.