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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638753
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Rodrigo Rossi Nogueira Rizzo, Universidade Cidade de Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: education Other: education combined with hypnosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Education
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology.
Other: education
Patients will be educated about pain neurophysiology.

Experimental: Education combined with hypnosis
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology combined with hypnosis.
Other: education combined with hypnosis
Patients will be educated about pain neurophysiology combined with hypnosis.




Primary Outcome Measures :
  1. Pain Numerical Rating Scale [ Time Frame: 2 weeks after randomization ]
    It is a translated and adapted scale for the Portuguese language that assesses pain intensity levels perceived by patients through a 11-point scale (ranging from 0 to 10), with 0 being classified as "no pain" and 10 "worst pain possible ". Patients will be asked to mark the level of the average pain intensity and the more intense based on the last seven days.

  2. Roland Morris Disability Questionnaire [ Time Frame: 2 weeks after randomization ]
    This questionnaire consists of 24 items describing everyday situations that patients may have difficulty in performing because of back pain. The greater the number of alternatives completed affirmatively, the greater the level of disability associated with lombar pain. Patients will be instructed to fill out the statements that actually describe their situation on the day of the interview. It's tool was already translated and adapted for the Portuguese language.


Secondary Outcome Measures :
  1. The Pain Catastrophizing Scale (PCS) [ Time Frame: 2 weeks and 3 months after randomization ]
    PCS is used to assess negative thoughts related to dor54. It is a self-administered questionnaire with 13 items and 3 subscales: impotence, magnification and rumination. A 5-point scale is used for each item. The score of each item is summed to define each subscale score or total score which may range from 0 to 52 points. It's tool was already translated and adapted for the Portuguese language.

  2. The Patient-Specific Functional Scale [ Time Frame: 2 weeks and 3 months after randomization ]
    We asked for the patient to identify up to 3 activities that are considered incapable of performing or presenting any difficulty. The measurement is made by Likert scale of 11 points for each activity, and the higher average score (ranging from 0 to 10 points) better is the patient's ability to make activity. It's tool was already translated and adapted for the Portuguese language.

  3. Global Perceived Effect Scale [ Time Frame: 2 weeks and 3 months after randomization ]
    It is a Likert scale of 11 points (ranging from -5 to +5) which compares the current state of the patient as the start of their symptoms. Positive scores are applied to patients who are better and negative scores apply to those who are worse off compared to the beginning of symptoms. The closer to the 5 means that the greater is the intensity perception. It's tool was already translated and adapted for the Portuguese language.

  4. Pain Numerical Rating Scale [ Time Frame: 3 months after randomization ]
    It is a translated and adapted scale for the Portuguese language that assesses pain intensity levels perceived by patients through a 11-point scale (ranging from 0 to 10), with 0 being classified as "no pain" and 10 "worst pain possible ". Patients will be asked to mark the level of the average pain intensity and the more intense based on the last seven days.

  5. Roland Morris Disability Questionnaire [ Time Frame: 3 months after randomization ]
    This questionnaire consists of 24 items describing everyday situations that patients may have difficulty in performing because of back pain. The greater the number of alternatives completed affirmatively, the greater the level of disability associated with lombar pain. Patients will be instructed to fill out the statements that actually describe their situation on the day of the interview. It's tool was already translated and adapted for the Portuguese language.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638753


Locations
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Brazil
Universidade Cidade de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Leonardo OP Costa, PhD Universidade Cidade de São Paulo
Publications:

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Responsible Party: Rodrigo Rossi Nogueira Rizzo, PT, MSc Student, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02638753    
Other Study ID Numbers: UNICID032016
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rodrigo Rossi Nogueira Rizzo, Universidade Cidade de Sao Paulo:
non specific chronic low back pain
education on pain neurophysiology
education on pain biology
education on pain neuroscience
hypnosis
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations