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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates method exercises
Sponsored by
Centro Universitário Augusto Motta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Universitário Augusto Motta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates method exercises associated with education to keep the abdomen relaxed

Pilates method exercises associated with education to keep the abdomen contracted

Arm Description

The group will receive guidance to perform the exercises in a relaxed and smooth way

The group will receive guidance on the specific activation of the center of strength (the powerhouse)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
April 12, 2022
Last Updated
August 4, 2023
Sponsor
Centro Universitário Augusto Motta
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1. Study Identification

Unique Protocol Identification Number
NCT05336500
Brief Title
Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Universitário Augusto Motta

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates method exercises associated with education to keep the abdomen relaxed
Arm Type
Experimental
Arm Description
The group will receive guidance to perform the exercises in a relaxed and smooth way
Arm Title
Pilates method exercises associated with education to keep the abdomen contracted
Arm Type
Active Comparator
Arm Description
The group will receive guidance on the specific activation of the center of strength (the powerhouse)
Intervention Type
Other
Intervention Name(s)
Pilates method exercises
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
12 weeks post randomisation
Title
Disability related
Description
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.
Time Frame
12 weeks post randomisation
Secondary Outcome Measure Information:
Title
Perception of global improvement
Description
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.
Time Frame
12 weeks post randomisation
Title
Specific functionality
Description
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).
Time Frame
12 weeks post randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro Universitário Augusto Motta
City
Rio de Janeiro
ZIP/Postal Code
21.041-020
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18923324
Citation
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Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates

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