Back to resultsPain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pain Neuroscience Education
Self-Management Education
Movement Control Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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.
Sites / Locations
- Physical Therapy ClinicRecruiting
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pain Neuroscience Education + Exercises
Self-Management Education + Exercises
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Pain Catastrophizing
Validated and translated to Brazilian-Portuguese, the Pain Catastrophizing scale (Br-PCS) is a self-administered questionnaire that presents 13 questions, divided into 3 domains: helplessness, magnification, and rumination. The scale has 5 points: 0 (minimum); 1 (slight); 2 (moderate); 3 (intense); and 4 (very intense). The final score ranges from 0 to 52 points, with the psychological risk being directly proportional to higher scores.
Pain Self-Efficacy
Validated for Brazilian-Portuguese, the Pain Self-Efficacy Scale (PSE) presents 10 questions scored from 0 (Not at all confident) to 6 (Completely confident). The score achieved on this scale can range from 0 to 60, higher values reflecting stronger self-efficacy beliefs.
Fear Avoidance Beliefs
Validated and translated to Brazilian-Portuguese, the Fear Avoidance Beliefs Questionnaire (FABQ-Brazil) is composed of 16 self-report items, subdivided into the FABQ-Phys, addressing beliefs related to occupational activities, and the FABQ-Work, work-related beliefs. However, the FABQ-Work score should be measured by adding items 6,7,9,10,11,12, and 15 with a score ranging from 0 to 42 and the FABQ-Phys through the sum of items 2,3,4, and 5, with the score ranging from 0 to 24 points.
Exercise Adherence
We will administer the Brazilian Portuguese version of the scale cross-culturally adapted. The tool is comprised of 16 items, 6 items directly assessing behavior adherence (Section B), while 10 additional items related to non-adherence reasons (Section C). The 16 items were classified using an ordinal scale of 5 possible answers (0 = strongly agree to 4 = totally disagree) with a possible score range from 0 to 64. A higher overall adherence score indicated better adherence to exercise.
Global Perceived Effect
The Global Perceived Effect Scale has the purpose of investigating musculoskeletal features, where the patient has the capacity to report improvement or deterioration over time, usually used to measure the effect of a therapy with the question: "Compared to when this episode began, how would you describe your low back currently?" Scored from -5 (much worse) to +5 (fully recovered), higher scores indicate improvement in the condition.
Full Information
NCT ID
NCT03778970
First Posted
December 16, 2018
Last Updated
February 27, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03778970
Brief Title
Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain
Official Title
Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
January 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Participants: One hundred and four volunteers (104) aged 18-50 years with chronic non-specific low back pain.
Interventions: The volunteers will be randomized into two treatment groups: self-management education and movement control exercises or pain neuroscience education and exercises based on movement control exercises. Two workshops of 40 minutes each will be administered as education approach and the exercise program along 2 months ( and 12 sessions distributed over 2 months.
Main outcome measures: Primary outcomes will include pain intensity and low back disability, and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia, exercise adherence and global perceived effect. These will be measured pre- and post-intervention and at the 1-month follow-up. Statistical analysis will be conducted following treatment intent principles, and treatment effects will be calculated using a mixed linear model, considering intervention groups as a factor and assessments over time as repeated measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial, superiority trial
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain Neuroscience Education + Exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Management Education + Exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
Intervention Type
Other
Intervention Name(s)
Self-Management Education
Intervention Description
A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
Intervention Type
Other
Intervention Name(s)
Movement Control Exercises
Intervention Description
Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
Primary Outcome Measure Information:
Title
Pain intensity - Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
Immediately after and at 1-month follow-up
Title
Low Back Pain Disability
Description
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.
Time Frame
Immediately after and at 1-month follow-up
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
Validated and translated to Brazilian-Portuguese, the Pain Catastrophizing scale (Br-PCS) is a self-administered questionnaire that presents 13 questions, divided into 3 domains: helplessness, magnification, and rumination. The scale has 5 points: 0 (minimum); 1 (slight); 2 (moderate); 3 (intense); and 4 (very intense). The final score ranges from 0 to 52 points, with the psychological risk being directly proportional to higher scores.
Time Frame
Immediately after and at 1-month follow-up
Title
Pain Self-Efficacy
Description
Validated for Brazilian-Portuguese, the Pain Self-Efficacy Scale (PSE) presents 10 questions scored from 0 (Not at all confident) to 6 (Completely confident). The score achieved on this scale can range from 0 to 60, higher values reflecting stronger self-efficacy beliefs.
Time Frame
Immediately after and at 1-month follow-up
Title
Fear Avoidance Beliefs
Description
Validated and translated to Brazilian-Portuguese, the Fear Avoidance Beliefs Questionnaire (FABQ-Brazil) is composed of 16 self-report items, subdivided into the FABQ-Phys, addressing beliefs related to occupational activities, and the FABQ-Work, work-related beliefs. However, the FABQ-Work score should be measured by adding items 6,7,9,10,11,12, and 15 with a score ranging from 0 to 42 and the FABQ-Phys through the sum of items 2,3,4, and 5, with the score ranging from 0 to 24 points.
Time Frame
Immediately after and at 1-month follow-up
Title
Exercise Adherence
Description
We will administer the Brazilian Portuguese version of the scale cross-culturally adapted. The tool is comprised of 16 items, 6 items directly assessing behavior adherence (Section B), while 10 additional items related to non-adherence reasons (Section C). The 16 items were classified using an ordinal scale of 5 possible answers (0 = strongly agree to 4 = totally disagree) with a possible score range from 0 to 64. A higher overall adherence score indicated better adherence to exercise.
Time Frame
at the beginning of following session, immediately after and at 1-month follow-up
Title
Global Perceived Effect
Description
The Global Perceived Effect Scale has the purpose of investigating musculoskeletal features, where the patient has the capacity to report improvement or deterioration over time, usually used to measure the effect of a therapy with the question: "Compared to when this episode began, how would you describe your low back currently?" Scored from -5 (much worse) to +5 (fully recovered), higher scores indicate improvement in the condition.
Time Frame
Immediately after and at 1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiago Del Antônio, MSc
Phone
+554384240199
Email
tiagodantonio@uenp.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Thais Chaves, PhD
Phone
+551633154413
Email
chavestc@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Chaves, PhD
Organizational Affiliation
Professor - Ribeirão Preto Medical School - University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Physical Therapy Clinic
City
Jacarezinho
State/Province
Paraná
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiago Del Antônio, PhD
Facility Name
University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais C Chaves, PhD
Phone
55 016 3315 4413
Email
chavestc@fmrp.usp.br
First Name & Middle Initial & Last Name & Degree
Tiago AG Del Antônio, MSc
Phone
+5543 84240199
Email
tiagodantonio@uenp.edu.br
12. IPD Sharing Statement
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Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain
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