Clinical trial NCT05047562: Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain
Official title: Effect of Pilates Method and Segmental Stabilization in Elderly People With Chronic Non-specific Low Back Pain: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic Pain
Exercise Therapy
Physical Therapy Modalities
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment
timeFrame: Baseline, week 16, 3 and 6 months after completion of treatment.
measure: Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
timeFrame: Baseline, week 16, 3 and 6 months after completion of treatment.
Secondary outcomes:
measure: Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.
timeFrame: Baseline, week 16, 3 and 6 months after completion of treatment.
measure: 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.
timeFrame: Baseline, week 16, 3 and 6 months after completion of treatment.
measure: 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.
timeFrame: Baseline, week 16, 3 and 6 months after completion of treatment.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ariela Cruz
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Amelia Marques
role: STUDY_DIRECTOR
References: