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

Chronic Low Back Pain Clinical Trial

Official title:

Pain Neuroscience Education vs. Self-management Programs Associated With Movement Control Exercises for Chronic Low Back Pain: a Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778970
• Other study ID #: 69172017.1.0000.5440
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: February 2019
• Source: University of Sao Paulo
• Contact: Tiago Del Antônio, MSc
• Phone: +554384240199
• Email: tiagodantonio[@]uenp.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Pain Neuroscience Education
Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
• Self-Management Education
A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
• Movement Control Exercises
Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.

Locations

Country	Name	City	State
Brazil	Physical Therapy Clinic	Jacarezinho	Paraná
Brazil	University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Immediately after and at 1-month follow-up
Secondary	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.	Immediately after and at 1-month follow-up
Secondary	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.	Immediately after and at 1-month follow-up
Secondary	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.	at the beginning of following session, immediately after and at 1-month follow-up
Secondary	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.	Immediately after and at 1-month follow-up