Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain

NCT03778970 | Unknown

• 1 other identifier: 69172017.1.0000.5440
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of this study is to compare the effects of an exercise program based on movement control exercises associated with self-management advice (SME) or pain neuroscience education (PNE) on the outcomes of pain intensity and pain disability in patients with chronic non-specific low back pain (CLBP).

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity - Numerical Pain Rating Scale (NPRS)

  The NPRS used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference (MCID) of 2.4 among patients with CLBP receiving exercise or education.

  Immediately after and at 1-month follow-up

• Low Back Pain Disability

  The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two. Previous research has found that ODI showed responsiveness to change for patients with CLBP, with MCID of 8 points.

  Immediately after and at 1-month follow-up

Secondary Outcomes (5)

• Pain Catastrophizing

  Immediately after and at 1-month follow-up

• Pain Self-Efficacy

  Immediately after and at 1-month follow-up

• Fear Avoidance Beliefs

  Immediately after and at 1-month follow-up

• Exercise Adherence

  at the beginning of following session, immediately after and at 1-month follow-up

• Global Perceived Effect

  Immediately after and at 1-month follow-up

Study Arms (2)

Pain Neuroscience Education + Exercises

EXPERIMENTAL

The PNE will follow the principles established by Explain Pain, addressing reconceptualization of pain, emphasizing modern neuroscience concepts. The PNE workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.

Other: Pain Neuroscience Education; Other: Movement Control Exercises

Self-Management Education + Exercises

ACTIVE COMPARATOR

The Self-Management Education (SME) strategy will be aligned with the "Back Book" concepts, focused on behavior change and encouraging participants to be active despite of the pain. The SME workshop will last 40 minutes (2 sessions). The movement control exercises will consist of active exercises that address posture and control of movements which are impaired and trigger pain. The session will last approximately 30 minutes, starting with the execution of the coordination exercises in the control of movement with an intensity of 10 to 30 repetitions and then performing exercises for stretching in 3 series of 30 seconds. Finally, strengthening exercises in 3 sets of 15 repetitions will be implemented. The exercises will be administered 1 session/week (volunteers will be oriented to execute the same exercises at home twice a week). The volunteers will receive 8 sessions at the clinic.

Other: Self-Management Education; Other: Movement Control Exercises

Interventions

Pain Neuroscience Education OTHER

Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop

Pain Neuroscience Education + Exercises

Self-Management Education OTHER

A self-management education (2 sessions during 40 minutes) administered by an interactive workshop

Self-Management Education + Exercises

Movement Control Exercises OTHER

Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.

Pain Neuroscience Education + Exercises; Self-Management Education + Exercises

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) non-specific chronic low back pain with a mechanical constituent caused by certain postures, activities, and movements, in addition to having at least 3 months of pain and/or episodes for at least half the previous 6 days, located between T12 and the gluteal folds; (2) pain intensity scores greater than 2 and greater than 14% on the Oswestry Low Back Disability Index and (3) positive results in 2 or more of the 6 tests to determine movement control impairment.

You may not qualify if:

• (1) red flags such as tumors or neoplastic diseases in the spine, inflammatory diseases, infections, and fractures; (2) central and peripheral, psychiatric, rheumatologic, and cardiac neurological diseases; (3) acute and symptomatic radiculopathy, lumbar stenosis, and spondylolisthesis; (4) pregnant women; and (5) individuals submitted to physiotherapeutic treatment during the last 6 months. Finally, volunteers will be advised about the non-use of pain medications 24 hours before the evaluations.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Physical Therapy Clinic

Jacarezinho, Paraná, Brazil

RECRUITING

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

Study Officials

• Thais Chaves, PhD

  Professor - Ribeirão Preto Medical School - University of São Paulo

  STUDY DIRECTOR

Central Study Contacts

Tiago Del Antônio, MSc

CONTACT

+554384240199; tiagodantonio@uenp.edu.br

Thais Chaves, PhD

CONTACT

+551633154413; chavestc@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be submitted to Pain Neuroscience Education or Self-Management Education plus movement control exercises. They will not be aware of the education approach they will receive. The assessors will also not be aware whether the participant received Pain Neuroscience Education or Self-Management Education.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Model Details: Randomized controlled clinical trial, superiority trial

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: January 20, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

BR (2)