Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates

Study Overview
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Brief Summary
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This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain. Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. Primary outcomes will be pain intensity and disability 12 weeks post randomisation.

Official Title
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Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Pilates method exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 years old; Low back pain for more than 3 months; Disability level ≥ 4 points on the Roland-Morris Disability Questionnaire (RMDQ); Ability to move independently with or without assistance; Ability to understand Portuguese enough to be able to fill in the questionnaires. Exclusion Criteria: The main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis); Surgery performed on the lumbar spine. Surgery performed on the lower limbs, or abdominal region less than 6 months ago; Performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months; Diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of pain; Scoliosis as the primary cause of pain; Unstable heart conditions; Presence of red flags such as malignancy/cancer, acute trauma (less than 6 months), infection, spinal cord/cauda equina compression.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates method exercises associated with education to keep the abdomen relaxed<br>The group will receive guidance to perform the exercises in a relaxed and smooth way | Other: Pilates method exercises<br>* Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks (twice a week for 60 minutes). The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way.<br>|
| Active Comparator: Pilates method exercises associated with education to keep the abdomen contracted<br>The group will receive guidance on the specific activation of the center of strength (the powerhouse) | Other: Pilates method exercises<br>* Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks (twice a week for 60 minutes). The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be obtained through self-report by the Brazilian version of the 11-point Numerical Pain Scale (NPS) (Costa et al., 2008; Vigotsky et al., 2021), which varies between 0 and 10 points, where 0 is no pain and 10 is the worst pain imaginable where individuals should report pain intensity based on the last 7 days. | 12 weeks post randomisation | 
| Disability related | Disability will be obtained through self-report by the Brazilian version of the Roland-Morris Disability Questionnaire (RMDQ) (Nusbaum et al., 2001), which has 24 statements involving activities and pain situations, to which the patient is instructed to answer yes only to those described in the assessment day, and each answer corresponds to one point. | 12 weeks post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of global improvement | Perception of global improvement will be obtained through self-report by the Perception of Global Effect Scale (PGES), 11 points ranging from -5 (much worse), 0 (no change) to +5 (completely recovered) (Costa et al., 2008). For all measures of perceived global effect participants will be asked: Compared to the start of your first episode, how do you describe your low back pain in the past few days?. A highly positive score indicates greater recovery, while a negative score indicates worsening of symptoms. | 12 weeks post randomisation | 
| Specific functionality | Specific functionality will be obtained through self-report by the Patient-specific functional scale (PSFS) (Costa et al., 2008), which consists of an interview in which the patient chooses three important activities whose execution is difficult or impossible due to low back pain. For each activity, a score of difficulty ranges from 0 (unable to perform) to 10 (able to perform at the same level as before the problem). | 12 weeks post randomisation |