Chronic Low Back Pain Clinical Trial
Official title:
Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain
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.
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.
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