NCT03399409

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

January 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
Last Updated

January 17, 2018

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

November 29, 2017

Last Update Submit

January 16, 2018

Conditions

Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Change in adherence to home exercises

    At home exercises checked on the daily Table of Exercises

    Change from Baseline Performance of Exercises at 2 weeks

Secondary Outcomes (2)

  • Change in levels of pain

    Change from Baseline Levels of Pain at 2 weeks

  • Change in levels of incapacity

    Change from Baseline Levels of Incapacity at 2 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL
Behavioral: Motivational Interviewing

Anti-inflammatory information program

ACTIVE COMPARATOR
Behavioral: Anti-inflammatory Information

Interventions

Motivational InterviewingBEHAVIORAL

Motivation techniques

Motivational Interviewing
Anti-inflammatory InformationBEHAVIORAL

Provision of information on anti-inflammatory products

Anti-inflammatory information program

Eligibility Criteria

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

You may qualify if:

  • Adults with low back pain receiving physiotherapy with home exercises

You may not qualify if:

  • Adults receiving physiotherapy without home exercises or for conditions other than low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Irene P carvalho, Ph.D.

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

January 16, 2018

Study Start

January 8, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

January 17, 2018

Record last verified: 2017-11