Motivational Interviewing in Physiotherapy for Patients W... | NCT03399409

Studies
Motivational Interviewing in Physiotherapy for Patients With Low Back Pain

NCT03399409

Sponsor

Universidade do Porto

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Motivational Interviewing

Interventions

Motivational Interviewing
Anti-inflammatory Information

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Nov 29, 2017

First Submission Date that Met QC Criteria

Jan 8, 2018

First Posted Date

Jan 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2018

Last Update Posted Date

Jan 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motivational Interviewing	Experimental		Behavioral: Motivational Interviewing
Anti-inflammatory information program	Active Comparator		Behavioral: Anti-inflammatory Information

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational Interviewing	Behavioral	Motivation techniques	Motivational Interviewing

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irene P carvalho, Ph.D.	Universidade do Porto	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided