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CompletedNCT03399409HELENAUpdated Jan 17, 2018

Motivational Interviewing in Physiotherapy for Patients With Low Back Pain

An interventional study of Motivational Interviewing and Anti-inflammatory Information in Motivational Interviewing, sponsored by Universidade do Porto. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Motivational Interviewing
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults with low back pain receiving physiotherapy with home exercises

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Motivational Interviewing

    Behavioral: Motivational Interviewing

  • Active comparator
    Anti-inflammatory information program

    Behavioral: Anti-inflammatory Information

Interventions

  • BehavioralMotivational Interviewing

    Motivation techniques

  • BehavioralAnti-inflammatory Information

    Provision of information on anti-inflammatory products

05

What researchers measure

Primary outcomes

  1. Change in adherence to home exercises

    At home exercises checked on the daily Table of Exercises

    Time frame: Change from Baseline Performance of Exercises at 2 weeks

Secondary outcomes

  1. Change in levels of pain

    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

  2. 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

    Time frame: Change from Baseline Levels of Incapacity at 2 weeks

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Study locations

No study locations are listed for this record.

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Registry details

Key details

Study ID
NCT03399409
Lead sponsor
Universidade do Porto
Responsible party
Sponsor
First posted
Jan 16, 2018
Start date
Jan 8, 2017
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jan 17, 2018

Study contacts

Irene P carvalho, Ph.D.
principal investigator · Universidade do Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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