Improvements in Adolescents With Back Pain After Pilates (PilatesBack)

July 23, 2018 updated by: Noelia González-Gálvez, Universidad Católica San Antonio de Murcia

Improvement in Adolescents With a History of Back Pain After Pilates

The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain. The objective of this study is to determine whether Pilates is effective for improving the trunk endurance and hamstring extensibility of adolescents with a history of back pain and to determine the differences between the sexes. The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26). The Pilates programme was conducted over 6 weeks. For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Back pain during the adolescent years is a precursor to chronic back pain in adulthood. The prevalence of back pain among schoolchildren is growing across the world, and it is similar to that of the adult population. Back pain is the first cause of disability in the world.

The main physical condition factor related to back pain and mobility among adolescents are trunk endurance and hamstring extensibility. The Pilates Method (PM) can be used as a specific exercise technique to train trunk endurance and hamstring extensibility, but there is little evidence regarding its effect in adolescents with a history of back pain.

The objectives of this study was: a) to analyse the effect of a Pilates programme on trunk endurance and extensibility in adolescents with a history of back pain and b) to determine the differences between the sexes.

The present research was a 6-week randomised controlled trial in which adolescents with a history of back pain were randomly assigned to a Pilates-based exercise group (PEG; n = 26) and a control group (CG; n = 26).

The sample was composed of 52 students with a mean age of 14.44 ± 0.7 years who had suffered back pain during the past year. They were distributed into the Pilates Exercise Group (PEG, n = 26) and the Control Group (CG, n = 26).

The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.

The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually.

For measuring trunk flexion and extension endurance, the bench trunk curl (BTC) test and the Sorensen (SOR) test were used, respectively. Hamstring extensibility was measured with the toe touch (TT) test. After the Pilates intervention, either the whole sample or males and females separately improved significantly (p ≤ 0.05) in the BTC, SOR or TT test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having had a history of back pain last year
  • being physically active in school physical education sessions

Exclusion Criteria:

  • presenting any musculoskeletal, neurological, cardiological, metabolic or rheumatic alteration
  • missing more than one session of the programme (91.66% attendance)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
Adolescents assigned to the CG did not receive any structured exercise programme; they just attended their usual Physical Education sessions.
EXPERIMENTAL: Pilates
The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session).
Other: Pilates
The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually. The sessions were divided into the warm-up (7 min), the main part (41 min), and the cool down (7 min). Tt concentrated on basic Pilates exercises involving the principal regions of the body (spine flexions, extensions and rotations; hip flexions, extensions and rotations; and shoulder abductions, adductions and rotations).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trunk flexor endurance
Time Frame: Pre and Post-intervention: change after 6 weeks of intervention
The bench trunk curl (BTC) test was used to evaluate trunk flexor endurance. The result is register in repetitions numbers. Higher values represent a better outcome.
Pre and Post-intervention: change after 6 weeks of intervention
Isometric trunk extension
Time Frame: Pre and Post-intervention: change after 6 weeks of intervention
Isometric trunk extension endurance was measured using the Sorensen (SOR) test. The result is register in seconds. Higher values represent a better outcome.
Pre and Post-intervention: change after 6 weeks of intervention
Hamstring extensibility
Time Frame: Pre and Post-intervention: change after 6 weeks of intervention
The toe touch (TT) test was used to evaluate hamstring extensibility. The result is register in centimeters. Higher values represent a better outcome.
Pre and Post-intervention: change after 6 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Pre and Post-intervention: change after 6 weeks of intervention
Weight was measured using a SECA 762 scale (SECA, Germany) in kilograms.
Pre and Post-intervention: change after 6 weeks of intervention
Height
Time Frame: Pre and Post-intervention: change after 6 weeks of intervention
Height was measured using a GPM anthropometer (Siber-Hegner, Switzerland) in meters.
Pre and Post-intervention: change after 6 weeks of intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noelia González, PhD., UCAM

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NGonzalez-Galvez

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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