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

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates group
Control group
Sponsored by
Universidade Cruzeiro do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring pilates method

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Central Institute of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pilates group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2019
Last Updated
January 23, 2020
Sponsor
Universidade Cruzeiro do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03854643
Brief Title
Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain
Official Title
Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain: Clinical Controlled, Randomized and Double Clinical Test.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cruzeiro do Sul

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 verify the influence of the Pilates Method on the improvement of pain in patients with non-specific chronic low back pain
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
pilates method

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pilates group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
lower back pain
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
34 (thirty-four) volunteers of both genders, aged between 18 and 35 years with non-specific back pain complaint for at least three (3) months
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Central Institute of Health
City
Mogi Das Cruzes
State/Province
São Paulo
ZIP/Postal Code
08780-911
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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