Low Back PainNCT02490722
Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
A study testing Patient education in people with Low Back Pain, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain. The patients will be recruited to four group based patient education lessons during a two months period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Dec 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
- low back pain minimum scored 4 on numeric rating scale
- able to conduct exercise training
Who cannot join
- unable to understand Danish
- psychiatric disorder
- dementia
- approaching operation
- current or approaching settlement regarding working ability or compensation as a result of low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain.
The patients will be recruited to four group based patient education lessons during a two months period. The study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. The patient education will be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires.
Read the detailed description
Design: Randomized controlled trial; intervention study. Patients: Patients with low back pain; referred to Nordsjaellands Hospital, Denmark. Inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia, approaching operation, current or approaching settlement regarding working ability or compensation as a result of low back pain. Intervention: Randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. The patient education will be delivered by physiotherapists, nurses and physicians. Outcome: functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires. Sample size: 74 participants.
- Conditions
- Low Back Pain
- Being tested
- Patient education
- Keywords
- Patient education, Empowerment
- Medical subject headings
- Low Back Pain, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
Four times two hours group based patient education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Four times two hours interdisciplinary patient education and usual care Receives: Other: Patient education |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of functions
Questionnaire
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary outcomes (5)
Change of pain
Questionnaire
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of self-efficacy
Questionnaire
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of quality of life
Questionnaire
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of depression
Questionnaire
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of physical function
Performance test
Measured: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionDec 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stig Molsted, PhD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490722
- Sponsor's protocol ID
- H-15006949
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2015
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heymans MW, van Tulder MW, Esmail R, Bombardier C, Koes BW. Back schools for non-specific low-back pain. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000261. doi: 10.1002/14651858.CD000261.pub2.
PubMed 15494995Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e.
PubMed 20147878Morone G, Paolucci T, Alcuri MR, Vulpiani MC, Matano A, Bureca I, Paolucci S, Saraceni VM. Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial. Eur J Phys Rehabil Med. 2011 Dec;47(4):533-41. Epub 2011 Apr 20.
PubMed 21508915
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
- ClinicalTrials.gov ID
- NCT02490722
- Acronym / sponsor ID
- H-15006949
- Conditions
- Low Back Pain
- Keywords
- Patient education, Empowerment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Jul 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.
The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain.
The patients will be recruited to four group based patient education lessons during a two months period. The study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. The patient education will be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires.
Detailed description
Design: Randomized controlled trial; intervention study. Patients: Patients with low back pain; referred to Nordsjaellands Hospital, Denmark. Inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia, approaching operation, current or approaching settlement regarding working ability or compensation as a result of low back pain. Intervention: Randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. The patient education will be delivered by physiotherapists, nurses and physicians. Outcome: functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires. Sample size: 74 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Patient educationFour times two hours interdisciplinary patient education and usual care |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults
- low back pain minimum scored 4 on numeric rating scale
- able to conduct exercise training
Key exclusion criteria (5 listed)
- unable to understand Danish
- psychiatric disorder
- dementia
- approaching operation
- current or approaching settlement regarding working ability or compensation as a result of 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 |
|---|---|---|
| Patient educationFour times two hours group based patient education | Other | Intervention |
Primary outcome
Change of functions
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Questionnaire
5 secondary outcomes
Change of pain
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of self-efficacy
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of quality of life
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of depression
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Change of physical function
Time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 15494995Heymans MW, van Tulder MW, Esmail R, Bombardier C, Koes BW. Back schools for non-specific low-back pain. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000261. doi: 10.1002/14651858.CD000261.pub2.
- Background: PubMed 20147878Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e.
- Background: PubMed 21508915Morone G, Paolucci T, Alcuri MR, Vulpiani MC, Matano A, Bureca I, Paolucci S, Saraceni VM. Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial. Eur J Phys Rehabil Med. 2011 Dec;47(4):533-41. Epub 2011 Apr 20.
- Individual participant dataSharing planned: No
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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.
Stig Molsted, PhD principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Low Back Pain, run by Nordsjaellands Hospital at 1 site in Denmark.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 29 Sep 2022. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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 of functions (time frame: Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490722, which also lists 3 linked publications.
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 29 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.