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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399409
Other study ID # HELENA
Secondary ID
Status Completed
Phase N/A
First received November 29, 2017
Last updated January 16, 2018
Start date January 8, 2017
Est. completion date June 30, 2017

Study information

Verified date November 2017
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
Motivation techniques
Anti-inflammatory Information
Provision of information on anti-inflammatory products

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Porto

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 from Baseline Levels of Pain at 2 weeks
Secondary 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 Change from Baseline Levels of Incapacity at 2 weeks
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