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

Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854643
• Other study ID #: 90158318.3.0000.5497
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: January 2020
• Source: Universidade Cruzeiro do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 30, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Other:
• Pilates 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.
• Control 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.

Locations

Country	Name	City	State
Brazil	Central Institute of Health	Mogi Das Cruzes	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cruzeiro do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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