Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain

Not Applicable

• Conditions: Low Back Pain

• Registration Number: NCT02729779
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Study Start: 2017-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-07-31
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Eight weeks after randomization	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disabitity	Eight weeks after randomization	Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Name	Time	Method
Disability	Six months after randomization	Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Global impression of improvement	Eight weeks and six months after randomization	Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale
Specific disability	Eight weeks and six months after randomization	Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Dynamic balance	Eight weeks and six months after randomization	Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)
Dynamic Balance	Eight weeks and six months after randomization	Dynamic balance will be evaluated by the Sit-up Test
Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators	Eight weeks and six months after randomization	Muscle strength will be evaluated by dynamometer
Pressure pain threshold	Eight weeks and six months after randomization	Pressure pain threshold will be evaluated by digital pressure algometer
Pain intensity	Six months after randomization	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

Trial Locations

Locations (1)

Physical Therapy Outpatient Department; 🇧🇷 Sao Paulo, Brazil