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Completed

NCT Number: NCT05336500

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Augusto Motta

Rio de Janeiro, 21.041-020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates method exercises

Other

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.

Primary outcomes

  1. Pain intensity

    Time frame: 12 weeks post randomisation

    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.

  2. Disability related

    Time frame: 12 weeks post randomisation

    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.

Secondary outcomes

  1. Perception of global improvement

    Time frame: 12 weeks post randomisation

    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.

  2. Specific functionality

    Time frame: 12 weeks post randomisation

    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).

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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