Pilates to Treat Low Back Pain

Pain Clinical Trial

— PTLBP  

Official title:

The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502059
• Other study ID #: CEP UNIFESP 0208/11
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2011
• Last updated: December 29, 2011
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.

Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).

Description:

Background:

Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.

Objectives:

To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.

Methods:

Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• non specific mechanical low back pain

• visual analogue scale for pain ranging from 4 to 7

Exclusion Criteria:

• previous back surgery

• spinal tumor

• spinal fracture

• pregnancy

• fibromyalgia

• inflammatory or infectious spinal diseases

• litigant patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain
• Quality of Life

Intervention

Other:
• Pilates
Pilates training - twice a week (one hour per class) during 90 days

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Measured with the visual analogue scale ranging from 0 to 10	Baseline, after 45, 90 and 180 days	No
Secondary	Change in function	Measured by the questionnaire Roland Morris	Baseline, after 45, 90 and 180 days	No
Secondary	Change in quality of life	Measured by the SF-36 questionnaire	Baseline, after 45, 90 and 180 days	No
Secondary	Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption	Measured by counting the number of tablets consumed per month	Baseline, after 45, 90 and 180 days	No