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Motivational Interviewing in Physiotherapy for Patients With Low Back Pain (HELENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399409
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Study Description
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Brief Summary:
This study aims to evaluate the efficacy of motivational interviewing (MI) on adherence to exercises and on levels of pain and incapacity in patients who engage in physiotherapy for low back pain. Sixty patients attending a 15-day program of physiotherapy for low back pain were allocated to experimental (EG) and control groups (CG). A regular treatment of physiotherapy with at-home exercises is offered to all participants. On day seven, MI is applied to the EG. The CG receives an anti-inflammatory information program.

Condition or disease Intervention/treatment Phase
Motivational Interviewing Behavioral: Motivational Interviewing Behavioral: Anti-inflammatory Information Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Motivational Interviewing in Physiotherapy for Patients With Low Back Pain: Effects on Adherence to Exercises and on Levels of Incapacity and Pain
Actual Study Start Date : January 8, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Motivational Interviewing Behavioral: Motivational Interviewing
Motivation techniques
Active Comparator: Anti-inflammatory information program Behavioral: Anti-inflammatory Information
Provision of information on anti-inflammatory products


Outcome Measures
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Primary Outcome Measures :
  1. Change in adherence to home exercises [ Time Frame: Change from Baseline Performance of Exercises at 2 weeks ]
    At home exercises checked on the daily Table of Exercises


Secondary Outcome Measures :
  1. Change in levels of pain [ Time Frame: Change from Baseline Levels of Pain at 2 weeks ]
    Intensity of pain on the Verbal Pain Intensity Scale. Score range: none, mild, moderate, severe and maximum possible pain

  2. Change in levels of incapacity [ Time Frame: Change from Baseline Levels of Incapacity at 2 weeks ]
    Ability to conduct daily activities on the Roland-Morris Disability Questionnaire. Scores range from 0 to 24, increasing values indicating greater levels of incapacity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with low back pain receiving physiotherapy with home exercises

Exclusion Criteria:

  • Adults receiving physiotherapy without home exercises or for conditions other than low back pain
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399409


Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: Irene P carvalho, Ph.D. Universidade do Porto
More Information
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03399409    
Other Study ID Numbers: HELENA
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Anti-Inflammatory Agents