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

August 4, 2023 updated by: Centro Universitário Augusto Motta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21.041-020
        • Centro Universitário Augusto Motta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
The group will receive guidance to perform the exercises in a relaxed and smooth way
Other: Pilates method exercises
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.
Active Comparator: Pilates method exercises associated with education to keep the abdomen contracted
The group will receive guidance on the specific activation of the center of strength (the powerhouse)
Other: Pilates method exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks post randomisation
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.
12 weeks post randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks post randomisation
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).
12 weeks post randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário Augusto Motta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

July 21, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAR/KAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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