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

Primary Purpose

Motivational Interviewing

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interviewing
Anti-inflammatory Information
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Motivational Interviewing

    Anti-inflammatory information program

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in adherence to home exercises
    At home exercises checked on the daily Table of Exercises

    Secondary Outcome Measures

    Change in levels of pain
    Intensity of pain on the Verbal Pain Intensity Scale. Score range: none, mild, moderate, severe and maximum possible pain
    Change in levels of incapacity
    Ability to conduct daily activities on the Roland-Morris Disability Questionnaire. Scores range from 0 to 24, increasing values indicating greater levels of incapacity

    Full Information

    First Posted
    November 29, 2017
    Last Updated
    January 16, 2018
    Sponsor
    Universidade do Porto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03399409
    Brief Title
    Motivational Interviewing in Physiotherapy for Patients With Low Back Pain
    Acronym
    HELENA
    Official Title
    Motivational Interviewing in Physiotherapy for Patients With Low Back Pain: Effects on Adherence to Exercises and on Levels of Incapacity and Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 8, 2017 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidade do Porto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motivational Interviewing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivational Interviewing
    Arm Type
    Experimental
    Arm Title
    Anti-inflammatory information program
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interviewing
    Intervention Description
    Motivation techniques
    Intervention Type
    Behavioral
    Intervention Name(s)
    Anti-inflammatory Information
    Intervention Description
    Provision of information on anti-inflammatory products
    Primary Outcome Measure Information:
    Title
    Change in adherence to home exercises
    Description
    At home exercises checked on the daily Table of Exercises
    Time Frame
    Change from Baseline Performance of Exercises at 2 weeks
    Secondary Outcome Measure Information:
    Title
    Change in levels of pain
    Description
    Intensity of pain on the Verbal Pain Intensity Scale. Score range: none, mild, moderate, severe and maximum possible pain
    Time Frame
    Change from Baseline Levels of Pain at 2 weeks
    Title
    Change in levels of incapacity
    Description
    Ability to conduct daily activities on the Roland-Morris Disability Questionnaire. Scores range from 0 to 24, increasing values indicating greater levels of incapacity
    Time Frame
    Change from Baseline Levels of Incapacity at 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Irene P carvalho, Ph.D.
    Organizational Affiliation
    Universidade do Porto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Motivational Interviewing in Physiotherapy for Patients With Low Back Pain

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