Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain

NCT ID: NCT05047562

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2023-03-31

Brief Summary

INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.

Conditions

Low Back Pain

Study Design

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

Study Groups

Pilates Group

Participants will undergo 16 sessions, twice a week on alternate days through the following Pilates Method exercises: Pelvic Curl, Leg lift Supine, One leg circle modified and Hundred modified. There will be 4 sets of 5 repetitions in the first week, 6 repetitions in the second week, 7 repetitions in the third week, 8 repetitions in the fourth week, 9 repetitions in the fifth week, 10 repetitions in the sixth to eighth week.

Group Type: ACTIVE_COMPARATOR

Pilates Group

Intervention Type: OTHER

16 Pilates exercise sessions twice a week for 2 months.

Segmental Stabilization Group

Participants will undergo 16 consultations, twice a week on alternate days through the following Segmental Stabilization exercises: multifidus in prone position, transverse abdomen in four supports, transverse abdomen in dorsal decubitus and transverse abdomen associated with multifidus in position orthostatic. There will be 4 sets of 10 repetitions of 10 seconds in all appointments.

Group Type: ACTIVE_COMPARATOR

Segmental Stabilization group

Intervention Type: OTHER

16 sessions of segmental stabilization exercises, 2 times a week for 2 months.

Interventions

Pilates Group

16 Pilates exercise sessions twice a week for 2 months.

Intervention Type: OTHER

Segmental Stabilization group

16 sessions of segmental stabilization exercises, 2 times a week for 2 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Non-specific low back pain for at least 3 months.
• Intensity of pain equal to or greater than 3 cm.

Exclusion Criteria

• Specific low back pain.
• Neurological involvement (radiculopathy, myelopathy).
• Previous spinal surgery.
• Any impediment to performing the exercises.
• Having had recent surgeries.
• Being on treatment for low back pain
• Not having cognitive ability to perform the exercises or be submitted to the proposed assessments
• Missing appointments three times in a row.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariela Cruz

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Amelia Marques

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Ariela Cruz

Role: CONTACT

ariela.tcruz@usp.br

5524992192494

Facility Contacts

Ariela Cruz

Role: primary

ariela.tcruz@usp.br

5524992192494

Other Identifiers

3270664

Identifier Type: -

Identifier Source: org_study_id