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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
education
education combined with hypnosis
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring non specific chronic low back pain, education on pain neurophysiology, education on pain biology, education on pain neuroscience, hypnosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Cidade de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education

Education combined with hypnosis

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Numerical Rating Scale
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.
Roland Morris Disability Questionnaire
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

The Pain Catastrophizing Scale (PCS)
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.
The Patient-Specific Functional Scale
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.
Global Perceived Effect Scale
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.
Pain Numerical Rating Scale
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.
Roland Morris Disability Questionnaire
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.

Full Information

First Posted
December 19, 2015
Last Updated
August 2, 2017
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02638753
Brief Title
Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain
Official Title
Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
non specific chronic low back pain, education on pain neurophysiology, education on pain biology, education on pain neuroscience, hypnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education
Arm Type
Active Comparator
Arm Description
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology.
Arm Title
Education combined with hypnosis
Arm Type
Experimental
Arm Description
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology combined with hypnosis.
Intervention Type
Other
Intervention Name(s)
education
Intervention Description
Patients will be educated about pain neurophysiology.
Intervention Type
Other
Intervention Name(s)
education combined with hypnosis
Intervention Description
Patients will be educated about pain neurophysiology combined with hypnosis.
Primary Outcome Measure Information:
Title
Pain Numerical Rating Scale
Description
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.
Time Frame
2 weeks after randomization
Title
Roland Morris Disability Questionnaire
Description
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.
Time Frame
2 weeks after randomization
Secondary Outcome Measure Information:
Title
The Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
2 weeks and 3 months after randomization
Title
The Patient-Specific Functional Scale
Description
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.
Time Frame
2 weeks and 3 months after randomization
Title
Global Perceived Effect Scale
Description
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.
Time Frame
2 weeks and 3 months after randomization
Title
Pain Numerical Rating Scale
Description
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.
Time Frame
3 months after randomization
Title
Roland Morris Disability Questionnaire
Description
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.
Time Frame
3 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo OP Costa, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Cidade de Sao Paulo
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16550448
Citation
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
Results Reference
background
PubMed Identifier
15322439
Citation
Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
Results Reference
background
PubMed Identifier
24256477
Citation
Adachi T, Fujino H, Nakae A, Mashimo T, Sasaki J. A meta-analysis of hypnosis for chronic pain problems: a comparison between hypnosis, standard care, and other psychological interventions. Int J Clin Exp Hypn. 2014;62(1):1-28. doi: 10.1080/00207144.2013.841471.
Results Reference
background
PubMed Identifier
18923324
Citation
Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
Results Reference
background
PubMed Identifier
17762300
Citation
Costa LO, Maher CG, Latimer J, Ferreira PH, Pozzi GC, Ribeiro RN. Psychometric characteristics of the Brazilian-Portuguese versions of the Functional Rating Index and the Roland Morris Disability Questionnaire. Spine (Phila Pa 1976). 2007 Aug 1;32(17):1902-7. doi: 10.1097/BRS.0b013e31811eab33.
Results Reference
background
PubMed Identifier
23036076
Citation
Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza IC, Torres IL, Fregni F, Caumo W. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med. 2012 Nov;13(11):1425-35. doi: 10.1111/j.1526-4637.2012.01492.x. Epub 2012 Oct 4.
Results Reference
background
PubMed Identifier
9256870
Citation
Chatman AB, Hyams SP, Neel JM, Binkley JM, Stratford PW, Schomberg A, Stabler M. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997 Aug;77(8):820-9. doi: 10.1093/ptj/77.8.820.
Results Reference
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Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain

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