Clinical trial NCT02729779: Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain
Official title: Effectiveness of the Pilates Method Versus Aerobic Exercises in the Treatment of Chronic Non-specific Low Back Pain in the Elderly: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. However, the evidence about the effectiveness of Pilates method in the treatment of elderly patients with low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. This randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of 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 elderly will be randomized into two groups: Pilates Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. Secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. We expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* Elderly complaining of non-specific low back pain for more than three months
* Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.

Exclusion Criteria:

* Contraindication to physical exercise;
* Back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests);
* Previous or scheduled back surgery ;
* Severe cardiorespiratory disease;
* Cancer;
* Cognitive impairment;
* Dependent gait;
* Patients who underwent physical therapy for low back pain in the last six months;
* Regular physical activity practitioners.

Primary outcomes:
measure: Pain intensity
timeFrame: Eight weeks after randomization
measure: Disabitity
timeFrame: Eight weeks after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: Six months after randomization
measure: Disability
timeFrame: Six months after randomization
measure: Global impression of improvement
timeFrame: Eight weeks and six months after randomization
measure: Specific disability
timeFrame: Eight weeks and six months after randomization
measure: Dynamic balance
timeFrame: Eight weeks and six months after randomization
measure: Dynamic Balance
timeFrame: Eight weeks and six months after randomization
measure: Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
timeFrame: Eight weeks and six months after randomization
measure: Pressure pain threshold
timeFrame: Eight weeks and six months after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Cristina MN Cabral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Oliveira NTB, Ricci NA, Dos Santos Franco YR, Salvador EMES, Almeida ICB, Cabral CMN. Effectiveness of the Pilates method versus aerobic exercises in the treatment of older adults with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2019 May 24;20(1):250. doi: 10.1186/s12891-019-2642-9.