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

NCT05047562 | Unknown

• 1 other identifier: 3270664
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Pain; Exercise Therapy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (2)

• Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment

  The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient. Change = Baseline, week 16, 3 and 6 months after the end of treatment.

  Baseline, week 16, 3 and 6 months after completion of treatment.

• Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment

  The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.

  Baseline, week 16, 3 and 6 months after completion of treatment.

Secondary Outcomes (3)

• Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.

  Baseline, week 16, 3 and 6 months after completion of treatment.

• Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.

  Baseline, week 16, 3 and 6 months after completion of treatment.

• Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.

  Baseline, week 16, 3 and 6 months after completion of treatment.

Study Arms (2)

Pilates Group

ACTIVE COMPARATOR

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.

Other: Pilates Group

Segmental Stabilization Group

ACTIVE COMPARATOR

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.

Other: Segmental Stabilization group

Interventions

Pilates Group OTHER

16 Pilates exercise sessions twice a week for 2 months.

Pilates Group

Segmental Stabilization group OTHER

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

Segmental Stabilization Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariela Cruz

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Amelia Marques

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Ariela Cruz

CONTACT

5524992192494; ariela.tcruz@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: June 13, 2019
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 17, 2021

Record last verified: 2021-08

Locations

BR (1)