Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain

NCT ID: NCT02922322

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-05-31

Brief Summary

To analyze the effectiveness of mat Pilates compared to no intervention in individuals with chronic nonspecific low back pain.

Detailed Description

There is evidence that exercises based on the Pilates method reduce pain in chronic nonspecific low back pain (CNLBP). However, is noticed the lack of studies that compare the effectiveness of mat Pilates to no intervention in the treatment of individual with CNLBP. Therefore, the main objective of the study is to analyze the effectiveness of mat Pilates compared to no intervention in patients with chronic nonspecific low back pain. It is a randomized controlled trial with two arms and double blinded (caregiver, assessor and outcome assessor), composed of 30 patients, aged between 18- 65 years (±22,47) of both sexes, diagnosed with chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The participants were randomly divided into two groups: Pilates Group (n = 15), intervention based on mat Pilates exercises, and Control Group (n =15) with no intervention. The mat Pilates group performed 16 sessions, twice a week in 60-minute duration each throughout eight weeks, whereas the control group participants kept usual cares until the end of the intervention. Both groups were evaluated before and after the program by a researcher who was unaware of the patients' allocation. The primary assessed outcomes: pain intensity (Pain numerical rating scale, and McGill questionnaire), quality of life (SF-36), and disability (Oswestry Low Back Pain Disability Questionnaire). In addition, the strength and muscle activation of transverse abdominal as secondary outcome assessed through the Stabilizer Pressure Biofeedback Unit test. As a result, the study infers that mat Pilates exercises have significantly improved all the evaluated outcomes. Thus, supporting clinical decisions for the treatment of chronic nonspecific low back pain.

Conditions

Nonspecific Chronic Low Back Pain; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pilates Group

The Pilates Group was composed by 15 participants evaluated before and after 16 sessions of intervention with mat Pilates exercises.

Group Type: ACTIVE_COMPARATOR

Pilates Group

Intervention Type: OTHER

The Pilates group program (PG) was composed of 16 sessions, 2x per week, 60 minute session each for 8 weeks. The intervention was based on 20 out of the 34 original mat exercises proposed by the Pilates method, classified into basic, intermediate or advanced levels divided into 4 cycles of 5 exercises each. The exercises were performed during two series of 10 repetitions respecting the patients skills.

Control Group

The control group was composed by 15 participants that received no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pilates Group

The Pilates group program (PG) was composed of 16 sessions, 2x per week, 60 minute session each for 8 weeks. The intervention was based on 20 out of the 34 original mat exercises proposed by the Pilates method, classified into basic, intermediate or advanced levels divided into 4 cycles of 5 exercises each. The exercises were performed during two series of 10 repetitions respecting the patients skills.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Complaining of non-specific low back pain for more than three months without radicular symptoms for a period exceeding 12 months.
• Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.
• Eligibility to practice physical activity responding to the Physical Activity Readiness Questionnaire - PAR-Q

Exclusion Criteria

• Degenerative or inflammatory pathologies of the spine,
• Acute crisis of pain in the shoulders, knees, ankles and spine
• Spinal tumors
• Recent surgery on the spine, lower and upper limbs
• Herniated disc
• Spondylolysis or spondylolisthesis
• Rheumatologic diseases
• Patients who are in labor dispute
• In treatment involving Pilates, physiotherapy or medication.
• Do not understand the writing and speaking Portuguese.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Carina Carvalho Correia Coutinho

Adjunct Professor, Head of the Federal University of Paraiba Clinical School of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

IDEMAR R DOS SANTOS JUNIOR, BPhty

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraíba

CARINA CC COUTINHO, MD

Role: STUDY_DIRECTOR

FEDERAL UNIVERSITY OF PARAIBA

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Other Identifiers

CAAE: 51317315.2.0000.5188

Identifier Type: -

Identifier Source: org_study_id