Clinical trial NCT02638753: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Numerical Rating Scale
timeFrame: 2 weeks after randomization
measure: Roland Morris Disability Questionnaire
timeFrame: 2 weeks after randomization
Secondary outcomes:
measure: The Pain Catastrophizing Scale (PCS)
timeFrame: 2 weeks and 3 months after randomization
measure: The Patient-Specific Functional Scale
timeFrame: 2 weeks and 3 months after randomization
measure: Global Perceived Effect Scale
timeFrame: 2 weeks and 3 months after randomization
measure: Pain Numerical Rating Scale
timeFrame: 3 months after randomization
measure: Roland Morris Disability Questionnaire
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Cidade de Sao Paulo
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Leonardo OP Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.