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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02729779
• Other study ID #: 53162216.9.0000.0064
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: December 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Pilates Group
Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.
• Aerobic Group
Elderly will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes, and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

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