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CompletedNCT03854643Updated Jan 27, 2020

Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain

An interventional study of Pilates group and Control group in Lower Back Pain, sponsored by Universidade Cruzeiro do Sul. Completed at 1 site in Brazil. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Universidade Cruzeiro do Sul · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Apr 2018, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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

Read the detailed description

Nonspecific low back pain is defined as localized pain and discomfort between the lower margins of the costal gradis and the lower gluteal folds. Chronic low back pain may be associated with central sensitization (CS) which is a proposed physiological phenomenon in which a deregulation in the central nervous system. Another relevant point related to worsening pain is kinesiophobia, which is fear of movement due to pain which impedes the movement or causes the person to gradually decrease their activities, thus limiting their functions, and restricting their participation in activities of daily living. The research design is a randomized, controlled, blinded clinical trial on the influence of central stabilization on the basis of the Pilates method in improving pain, kinesiophobia, central sensitization and function in patients with chronic low back pain of non-specific origin. It is a research with four evaluations: pre-treatment, post-two weeks, post four weeks and three months after the end of treatment. An evaluation form will be used, containing questions about personal data, history of diseases, ethylism, smoking, medications used and pain intensity by the numerical scale of pain. The Tampa scale for kinesiophobia will also be used. The Central Sensitization questionnaire, which has two parts, part A containing 25 questions about the presence of pain in the last 3 months and part B containing 10 questions about possible medical diagnoses will be used. Finally, the Oswestry 2.0 Disability Index will be applied. 34 (thirty-four) volunteers, of both genders, aged between 18 and 35 years old will be recruited for at least 3 (three) months of non-specific back pain; of which 17 (seventeen) will undergo the Pilates Method and 17 (seventeen) will be part of the control group. Pilates exercises will be performed three times a week for 4 weeks, totaling 12 sessions of treatment, by a researcher with training in the method and previous training in performing the exercises. The re-evaluations will be performed after the sixth treatment session (Pilates group) and two weeks after the initial evaluation (control group), after the twelfth session (Pilates group) and after four weeks for the control group. A reevaluation will also be performed after 3 months of treatment, in order to analyze how well the Pilates method was effective in maintaining the improvement of the patient's clinical condition.

02

Conditions studied

  • Lower Back Pain

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Keywords

  • pilates method
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 34 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Universidade Cruzeiro do Sul is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Pilates group

    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

  • Experimental
    Control group

    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

  • OtherPilates group

    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.

  • OtherControl 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.

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Central Institute of Health
    Mogi das Cruzes, São Paulo 08780-911, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03854643
Lead sponsor
Universidade Cruzeiro do Sul
Responsible party
Leandro Lazzareschi (Principal Investigator, University of Mogi das Cruzes) — Principal investigator
First posted
Feb 26, 2019
Start date
Apr 2, 2018
Primary completion
Oct 15, 2018
Completion
Jul 30, 2019
Last update
Jan 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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