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

NCT02638753 | Completed

• 1 other identifier: UNICID032016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

non specific chronic low back pain; education on pain neurophysiology; education on pain biology; education on pain neuroscience; hypnosis

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks after randomization

• 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.

  2 weeks after randomization

Secondary Outcomes (5)

• The Pain Catastrophizing Scale (PCS)

  2 weeks and 3 months after randomization

• The Patient-Specific Functional Scale

  2 weeks and 3 months after randomization

• Global Perceived Effect Scale

  2 weeks and 3 months after randomization

• Pain Numerical Rating Scale

  3 months after randomization

• Roland Morris Disability Questionnaire

  3 months after randomization

Study Arms (2)

Education

ACTIVE COMPARATOR

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

Other: education

Education combined with hypnosis

EXPERIMENTAL

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

Other: education combined with hypnosis

Interventions

education OTHER

Patients will be educated about pain neurophysiology.

Education

education combined with hypnosis OTHER

Patients will be educated about pain neurophysiology combined with hypnosis.

Education combined with hypnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Universidade Cidade de Sao Paulo

São Paulo, Brazil

Location

Related Publications (7)

• 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.

  PMID: 16550448 BACKGROUND

• 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.

  PMID: 15322439 BACKGROUND

• 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.

  PMID: 24256477 BACKGROUND

• 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.

  PMID: 18923324 BACKGROUND

• 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.

  PMID: 17762300 BACKGROUND

• 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.

  PMID: 23036076 BACKGROUND

• 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.

  PMID: 9256870 BACKGROUND

MeSH Terms

Interventions

Educational Status; Hypnosis

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leonardo OP Costa, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc Student

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

BR (1)