Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Motor Control Exercises vs Standard Exercises in Patients With Unspecific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633917
• Other study ID #: CI 10/374
• Status: Completed
• Phase: N/A
• First received: December 9, 2015
• Last updated: December 14, 2015
• Start date: June 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Description:

Eighty-four subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated into control group (who received one hour of standard physiotherapy exercises every days during ten days) or intervention group (who received one hour of control motor exercises every days during ten days). One month after finishing these ten days, patients should perform a home-based exercises program during two months (control group performed home-based standard physiotherapy exercises; intervention group performed home-based motor control exercises). Pain (visual analogic scale), incapacity index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the intervention, one month and three months after ending the first ten days of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Motor control exercises
exercises to strength the lumbar musculature and control the posture
• Standard exercises
general exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.	Roland Morris questionnaire	The day before beginning the intervention, one month and three months after the first ten days of intervention	No
Secondary	Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.	diary	The day before beginning the intervention, one month and three months after the first ten days of intervention	No