Motivational InterviewingHELENANCT03399409
Motivational Interviewing in Physiotherapy for Patients With Low Back Pain
A study testing Motivational Interviewing and Anti-inflammatory Information in people with Motivational Interviewing, run by Universidade do Porto.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motivational Interviewing
- What is being tested?
- Motivational Interviewing and Anti-inflammatory Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with low back pain receiving physiotherapy with home exercises
Who cannot join
- Adults receiving physiotherapy without home exercises or for conditions other than low back pain
About this study
Official title: 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.
- Conditions
- Motivational Interviewing
- Being tested
- Motivational Interviewing, Anti-inflammatory Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivation techniques
Anti-inflammatory InformationBehavioural
Provision of information on anti-inflammatory products
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
| Anti-inflammatory information program | Active comparator | Not described Receives: Behavioral: Anti-inflammatory Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to home exercises
At home exercises checked on the daily Table of Exercises
Measured: Change from Baseline Performance of Exercises at 2 weeks
Secondary outcomes (2)
Change in levels of pain
Intensity of pain on the Verbal Pain Intensity Scale. Score range: none, mild, moderate, severe and maximum possible pain
Measured: 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
Measured: Change from Baseline Levels of Incapacity at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start8 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene P carvalho, Ph.D., Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399409
- Sponsor's protocol ID
- HELENA
- Acronym
- HELENA
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing in Physiotherapy for Patients With Low Back Pain: Effects on Adherence to Exercises and on Levels of Incapacity and Pain
- ClinicalTrials.gov ID
- NCT03399409
- Acronym / sponsor ID
- HELENA / HELENA
- Conditions
- Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 8 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing |
| Anti-inflammatory information program | Active comparator | Behavioral: Anti-inflammatory Information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with low back pain receiving physiotherapy with home exercises
Key exclusion criteria (1 listed)
- Adults receiving physiotherapy without home exercises or for conditions other than low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivation techniques | Behavioural | Motivational Interviewing |
| Anti-inflammatory InformationProvision of information on anti-inflammatory products | Behavioural | Anti-inflammatory information program |
Primary outcome
Change in adherence to home exercises
Time frame: Change from Baseline Performance of Exercises at 2 weeks
At home exercises checked on the daily Table of Exercises
2 secondary outcomes
Change in levels of pain
Time frame: Change from Baseline Levels of Pain at 2 weeks
Change in levels of incapacity
Time frame: Change from Baseline Levels of Incapacity at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene P carvalho, Ph.D. principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Anti-inflammatory Information in people with Motivational Interviewing, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to home exercises (time frame: Change from Baseline Performance of Exercises at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.