NCT02633917

Brief Summary

The purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable low-back-pain

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

December 9, 2015

Last Update Submit

December 14, 2015

Conditions

Keywords

Low back painMotor controlJoint mobilization

Outcome Measures

Primary Outcomes (1)

  • Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.

    Visual analogic scale

    The day before beginning the intervention, one month and three months after the first ten days of intervention

Secondary Outcomes (2)

  • Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.

    The day before beginning the intervention, one month and three months after the first ten days of intervention

  • Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.

    The day before beginning the intervention, one month and three months after the first ten days of intervention

Study Arms (2)

Motor control exercises

EXPERIMENTAL

One group should perform motor control exercises

Behavioral: Motor control exercises

Standard exercises

ACTIVE COMPARATOR

the other group should perform standard physiotherapy exercises

Behavioral: Standard exercises

Interventions

exercises to strength the lumbar musculature and control the posture

Motor control exercises

general exercises

Standard exercises

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects should be independent to walk
  • subjects should have unspecific low back pain during at least the last two months
  • subjects should have had at least two recidives of low back pain within the last year

You may not qualify if:

  • subjects with concomitant pathologies that impede the performance of exercises
  • pregnants
  • subjects with oncologic pathologies
  • subjects with cognitive alterations that impede the understanding of the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustavo Plaza-Manzano, Ph.D

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 17, 2015

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

December 17, 2015

Record last verified: 2015-12