NCT01502059

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
Last Updated

December 30, 2011

Status Verified

December 1, 2011

Enrollment Period

2.5 years

First QC Date

December 27, 2011

Last Update Submit

December 29, 2011

Conditions

PainQuality of Life

Keywords

PilatesExerciseTreatmentLow back painPainFunction

Outcome Measures

Primary Outcomes (1)

  • Change in pain

    Measured with the visual analogue scale ranging from 0 to 10

    Baseline, after 45, 90 and 180 days

Secondary Outcomes (3)

  • Change in function

    Baseline, after 45, 90 and 180 days

  • Change in quality of life

    Baseline, after 45, 90 and 180 days

  • Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption

    Baseline, after 45, 90 and 180 days

Study Arms (2)

Pilates Group

EXPERIMENTAL

This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.

Other: Pilates

Control Groups

NO INTERVENTION

This group keep their usual treatment and can do the Pilates training after the end of the study.

Interventions

PilatesOTHER

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

Pilates Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • non specific mechanical low back pain
  • visual analogue scale for pain ranging from 4 to 7

You may not qualify if:

  • previous back surgery
  • spinal tumor
  • spinal fracture
  • pregnancy
  • fibromyalgia
  • inflammatory or infectious spinal diseases
  • litigant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04329010, Brazil

Location

MeSH Terms

Conditions

PainMotor ActivityLow Back Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBack Pain

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Anamaria Jones, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2011

First Posted

December 30, 2011

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

December 30, 2011

Record last verified: 2011-12

Locations

BR(1)