NCT03854643

Brief Summary

This study aims to verify the influence of the Pilates Method on the improvement of pain in patients with non-specific chronic low back pain

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

February 16, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

pilates method

Outcome Measures

Primary Outcomes (1)

  • lower back pain

    Intensity of pain through the visual analogic scale, which contains 11 points, ranging from 0 to 10, with 0 corresponding to "no pain" and 10 to unbearable pain.

    3 months

Study Arms (2)

Pilates group

EXPERIMENTAL

17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.

Other: Pilates group

Control group

EXPERIMENTAL

17 (seventeen) volunteers of both genders, aged between 18 and 35 years, were recruited for at least 3 (three) months with non-specific back pain. These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.

Other: Control group

Interventions

Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.

Pilates group

These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.

Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details34 (thirty-four) volunteers of both genders, aged between 18 and 35 years with non-specific back pain complaint for at least three (3) months
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Present lumbar pain of degree greater than or equal to 3;
  • Present lumbar pain for twelve weeks or more;
  • Present low back pain without it being related to any specific pathology or cause;
  • The Volunteers may not be undergoing physiotherapeutic or drug treatment

You may not qualify if:

  • Volunteers who present with pain grade 1 or 2 of low back pain;
  • Volunteers with severe movement limitations;
  • Neurological or neurological diseases that interfere with significant neuromotor
  • Individuals who did not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Health

Mogi das Cruzes, São Paulo, 08780-911, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A blind researcher will be responsible for evaluating the volunteers. It is worth mentioning that this researcher will not have access to the research group that the participants will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 26, 2019

Study Start

April 2, 2018

Primary Completion

October 15, 2018

Study Completion

July 30, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations