Low Back PainTENSNCT02564185
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
A study testing Usual practice and Education program in people with Low Back Pain, run by Hopital Foch at 1 site in France.
Trial summary
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Usual practice and Education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Oct 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain
- Treatment with transcutaneous electrical nerve stimulation (TENS)
Who cannot join
- Contra-indication of TENS
- Patients with mental disorders
- Lack of autonomy or patients living alone at home without help
- Concomitant inclusion in another research on the treatment of pain
Trial locations and contacts
1 site in 1 country.
About this study
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.
The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.
- Conditions
- Low Back Pain
- Being tested
- Usual practice, Education program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual practiceOther
Education programOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The "control" group will follow usual practice. Receives: Other: Usual practice |
| Education program | Experimental | The "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months. Receives: Other: Usual practice; Other: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).
Measured: 6 months
Quality of life
DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)
Measured: 6 months
Secondary outcomes (4)
Pain
Numerical scale
Measured: 6 months
Neuropathic pain
DN4 questionnaire
Measured: 6 months
Social impact
Changes in the employment status
Measured: 6 months
Evaluation of the program
Self-administered questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564185
- Sponsor's protocol ID
- 2009/51
- Other IDs
- 2009-A01193-54
- Acronym
- TENS
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
- ClinicalTrials.gov ID
- NCT02564185
- Acronym / sponsor ID
- TENS / 2009/51
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Sep 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.
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.
The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Usual practiceThe "control" group will follow usual practice. |
| Education program | Experimental | Other: Usual practice, Other: Education programThe "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low back pain
- Treatment with transcutaneous electrical nerve stimulation (TENS)
Key exclusion criteria (4 listed)
- Contra-indication of TENS
- Patients with mental disorders
- Lack of autonomy or patients living alone at home without help
- Concomitant inclusion in another research on the treatment of 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 |
|---|---|---|
| Usual practice | Other | Control, Education program |
| Education program | Other | Education program |
Primary outcome
Quality of life
Time frame: 6 months
EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).
Quality of life
Time frame: 6 months
DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)
4 secondary outcomes
Pain
Time frame: 6 months
Neuropathic pain
Time frame: 6 months
Social impact
Time frame: 6 months
Evaluation of the program
Time frame: 6 months
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 1 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual practice and Education program in people with Low Back Pain, run by Hopital Foch 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 4 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 1 Feb 2017. 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?
Quality of life (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 Feb 2017.