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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis

NCT05042115

Low Back Pain

COMPLETED NA

Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain

NCT05953454

Chronic Low-back Pain

UNKNOWN NA

Pain Neurophysiology Education in Chronic Low Back Pain

NCT06915532

Chronic Low Back Pain (CLBP)

COMPLETED NA

Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

NCT04879394

Low Back Pain

UNKNOWN NA

Online Pain Education in Addition to Usual Care in Chronic Pain.

NCT05302180

Chronic Pain Musculoskeletal Pain

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education

Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology.

Group Type ACTIVE_COMPARATOR

education

Intervention Type OTHER

Patients will be educated about pain neurophysiology.

Education combined with hypnosis

Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology combined with hypnosis.

Group Type EXPERIMENTAL

education combined with hypnosis

Intervention Type OTHER

Patients will be educated about pain neurophysiology combined with hypnosis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

education

Patients will be educated about pain neurophysiology.

Intervention Type OTHER

education combined with hypnosis

Patients will be educated about pain neurophysiology combined with hypnosis.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with non specific chronic low back pain, defined as pain or discomfort between the coastal margins and lower gluteal folds, with or without symptoms related to lower limbs for at least three months, of both genders, aged between 18 and 80 years and literate in Portuguese.

Exclusion Criteria

* Patients with back pain by nerve root compromise, serious spinal pathologies (such as fracture, tumor, inflammatory and infectious diseases), cardio-respiratory and uncompensated metabolic diseases, previous back surgery , pregnancy, presence of some contraindications to exercise, and have a hearing or understanding problem that prevents the understanding of simple information.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No