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Completed

NCT Number: NCT03854643

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Health

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pilates group

Other

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.

Control Group

Other

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 outcomes

  1. lower back pain

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Universidade Cruzeiro do Sul

Other

Registry information

Official study title

Influence of the Pilates Method in the Treatment of Unexpected Chronic Lombar Pain: Clinical Controlled, Randomized and Double Clinical Test.

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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