Non-specific Chronic Lower Back PainNCT02466360
What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain?
An observational study of Non-specific Chronic Lower Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Chronic Lower Back Pain
- What is being tested?
- Back Belief questionnaire, QUEBEC scale and Fear Avoidance beliefs questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Apr 2014
- Phase
- Observational
- 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
Study population: patients with chronic lower back pain
Who may be able to join
- Male or female who are at least 18 years old
- Patients with non-specific chronic lower back pain
Who cannot join
- Mental or physical disabilities incompatible with focus groups/individual interviews and filling out questionnaires.
- Inability to understand or speak French properly
- Symptomatic lower back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain : a Qualitative Study
Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.
Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.
The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.
Read the detailed description
Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.
Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.
The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.
- Conditions
- Non-specific Chronic Lower Back Pain
- Being tested
- Back Belief questionnaire, QUEBEC scale, Fear Avoidance beliefs questionnaire, Visual analog scale, individual interviews
- Keywords
- Non-specific chronic lower back pain, Physical activity, Self-exercises, Brakes, Levers, Adhesion, Self-care
- Medical subject headings
- Motor Activity, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back Belief questionnaireBehavioural
QUEBEC scaleBehavioural
Fear Avoidance beliefs questionnaireBehavioural
Visual analog scaleBehavioural
individual interviewsBehavioural
Focus groupsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| chronic lower back pain | Not described Receives: Behavioral: Back Belief questionnaire; Behavioral: QUEBEC scale; Behavioral: Fear Avoidance beliefs questionnaire; Behavioral: Visual analog scale; Behavioral: individual interviews; Behavioral: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual interviews
patients with non-specific chronic lower back pain explain directly to their doctors what is preventing them from having physical activity
Measured: at day 1
Secondary outcomes (5)
questions about their lower back pain and physical activity
Measured: at day 1
Back Belief questionnaire
- Back Belief questionnaire that evaluates patients' knowledge about lower back pain
Measured: at day 1
QUEBEC scale
- QUEBEC scale that evaluates the impact of lower back pain on the daily lives of patients
Measured: at day 1
Fear Avoidance Beliefs questionnaire
- Fear Avoidance Beliefs questionnaire that evaluates fears and beliefs about the disease
Measured: at day 1
Visual Analog Scale
Visual Analog Scale that evaluates pain
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Lower Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466360
- Sponsor's protocol ID
- CHU-0237
- Status last verified
- Jun 2015
- First submitted
- 5 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain : a Qualitative Study
- ClinicalTrials.gov ID
- NCT02466360
- Acronym / sponsor ID
- CHU-0237
- Conditions
- Non-specific Chronic Lower Back Pain
- Keywords
- Non-specific chronic lower back pain, Physical activity, Self-exercises, Brakes, Levers, Adhesion, Self-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.
Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.
The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.
Detailed description
Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.
Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.
The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic lower back pain | – | Behavioral: Back Belief questionnaire, Behavioral: QUEBEC scale, Behavioral: Fear Avoidance beliefs questionnaire, Behavioral: Visual analog scale, Behavioral: individual interviews, Behavioral: Focus groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic lower back pain
Key inclusion criteria (2 listed)
- Male or female who are at least 18 years old
- Patients with non-specific chronic lower back pain
Key exclusion criteria (3 listed)
- Mental or physical disabilities incompatible with focus groups/individual interviews and filling out questionnaires.
- Inability to understand or speak French properly
- Symptomatic lower 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 |
|---|---|---|
| Back Belief questionnaire | Behavioural | chronic lower back pain |
| QUEBEC scale | Behavioural | chronic lower back pain |
| Fear Avoidance beliefs questionnaire | Behavioural | chronic lower back pain |
| Visual analog scale | Behavioural | chronic lower back pain |
| individual interviews | Behavioural | chronic lower back pain |
| Focus groups | Behavioural | chronic lower back pain |
Primary outcome
Individual interviews
Time frame: at day 1
patients with non-specific chronic lower back pain explain directly to their doctors what is preventing them from having physical activity
5 secondary outcomes
questions about their lower back pain and physical activity
Time frame: at day 1
Back Belief questionnaire
Time frame: at day 1
QUEBEC scale
Time frame: at day 1
Fear Avoidance Beliefs questionnaire
Time frame: at day 1
Visual Analog Scale
Time frame: at day 1
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 9 Jun 2015.
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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.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-specific Chronic Lower Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 3 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 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Individual interviews (time frame: at day 1). 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 9 Jun 2015.