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

Motivational Interviewing in Physiotherapy for Patients With Low Back Pain: Effects on Adherence to Exercises and on Levels of Incapacity and Pain

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.

Study Overview

• Status: Completed
• Conditions: Motivational Interviewing
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Anti-inflammatory Information

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Principal Investigator: Irene P carvalho, Ph.D., Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Anti-Inflammatory Agents
• Other Study ID Numbers: HeLeNa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No