Recurrent Low Back PainNCT01539863
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
A study testing maintenance care and Treatment as needed in people with Recurrent Low Back Pain and Persistent Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Low Back Pain, Persistent Low Back Pain, Chronic Low Back Pain
- What is being tested?
- maintenance care and Treatment as needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-specific low back pain > 30 days previous year
- non-specific low back pain with previous episodes
- age 18-65
- access to a mobile phone
- knowledge of how to text message
- proficiency in the Swedish language
- must rate themselves as "definitely improved" by the 4th visit
Who cannot join
- pregnancy
- contraindication to spinal manipulative therapy
- liability issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up
As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.
This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.
This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.
- Being tested
- maintenance care, Treatment as needed
- 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.
maintenance careOther
Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
Treatment as neededOther
Participants may never receive treatment, there is no upper limit
| Study group | Role | What they receive |
|---|---|---|
| Treatment at regular intervals | Experimental | Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management Receives: Other: maintenance care |
| Treatment as needed | Active comparator | Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration Receives: Other: Treatment as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days With Bothersome Low Back Pain
Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.
Measured: 12 months
Secondary outcomes (1)
Cost-effectiveness
Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent Low Back PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iben Axen, Karolinska Institutet
- Investigators
- Irene Jensen, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539863
- Sponsor's protocol ID
- KIIMMIIR
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2012
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eklund A, Palmgren PJ, Jakobsson U, Axen I. Development and evaluation of the MAINTAIN instrument, selecting patients suitable for secondary or tertiary preventive manual care: the Nordic maintenance care program. Chiropr Man Therap. 2022 Mar 17;30(1):15. doi: 10.1186/s12998-022-00424-6.
PubMed 35300729Eklund A, Hagberg J, Jensen I, Leboeuf-Yde C, Kongsted A, Lovgren P, Jonsson M, Petersen-Klingberg J, Calvert C, Axen I. The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. Chiropr Man Therap. 2020 Apr 21;28(1):19. doi: 10.1186/s12998-020-00309-6.
PubMed 32316995Eklund A, Bergstrom G, Bodin L, Axen I. Do psychological and behavioral factors classified by the West Haven-Yale Multidimensional Pain Inventory (Swedish version) predict the early clinical course of low back pain in patients receiving chiropractic care? BMC Musculoskelet Disord. 2016 Feb 12;17:75. doi: 10.1186/s12891-016-0933-y.
PubMed 26867930Eklund A, Bergstrom G, Bodin L, Axen I. Psychological and behavioral differences between low back pain populations: a comparative analysis of chiropractic, primary and secondary care patients. BMC Musculoskelet Disord. 2015 Oct 19;16:306. doi: 10.1186/s12891-015-0753-5.
PubMed 26483193Eklund A, Axen I, Kongsted A, Lohela-Karlsson M, Leboeuf-Yde C, Jensen I. Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial. Trials. 2014 Apr 2;15:102. doi: 10.1186/1745-6215-15-102.
PubMed 24690201
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up
- ClinicalTrials.gov ID
- NCT01539863
- Acronym / sponsor ID
- KIIMMIIR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Posted 12 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.
This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.
This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment at regular intervals | Experimental | Other: maintenance careParticipants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management |
| Treatment as needed | Active comparator | Other: Treatment as neededParticipants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- non-specific low back pain > 30 days previous year
- non-specific low back pain with previous episodes
- age 18-65
- access to a mobile phone
- knowledge of how to text message
Key exclusion criteria (3 listed)
- pregnancy
- contraindication to spinal manipulative therapy
- liability issues
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 |
|---|---|---|
| maintenance careParticipants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor | Other | Treatment at regular intervals |
| Treatment as neededParticipants may never receive treatment, there is no upper limit | Other | Treatment as needed |
Primary outcome
Number of Days With Bothersome Low Back Pain
Time frame: 12 months
Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.
1 secondary outcome
Cost-effectiveness
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35300729Eklund A, Palmgren PJ, Jakobsson U, Axen I. Development and evaluation of the MAINTAIN instrument, selecting patients suitable for secondary or tertiary preventive manual care: the Nordic maintenance care program. Chiropr Man Therap. 2022 Mar 17;30(1):15. doi: 10.1186/s12998-022-00424-6.
- Derived from this study: PubMed 32316995Eklund A, Hagberg J, Jensen I, Leboeuf-Yde C, Kongsted A, Lovgren P, Jonsson M, Petersen-Klingberg J, Calvert C, Axen I. The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. Chiropr Man Therap. 2020 Apr 21;28(1):19. doi: 10.1186/s12998-020-00309-6.
- Derived from this study: PubMed 26867930Eklund A, Bergstrom G, Bodin L, Axen I. Do psychological and behavioral factors classified by the West Haven-Yale Multidimensional Pain Inventory (Swedish version) predict the early clinical course of low back pain in patients receiving chiropractic care? BMC Musculoskelet Disord. 2016 Feb 12;17:75. doi: 10.1186/s12891-016-0933-y.
- Derived from this study: PubMed 26483193Eklund A, Bergstrom G, Bodin L, Axen I. Psychological and behavioral differences between low back pain populations: a comparative analysis of chiropractic, primary and secondary care patients. BMC Musculoskelet Disord. 2015 Oct 19;16:306. doi: 10.1186/s12891-015-0753-5.
- Derived from this study: PubMed 24690201Eklund A, Axen I, Kongsted A, Lohela-Karlsson M, Leboeuf-Yde C, Jensen I. Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial. Trials. 2014 Apr 2;15:102. doi: 10.1186/1745-6215-15-102.
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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 Jensen, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintenance care and Treatment as needed in people with Recurrent Low Back Pain and Persistent Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
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 7 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 16 Oct 2023. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days With Bothersome Low Back Pain (time frame: 12 months). 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 NCT01539863, which also lists 5 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 16 Oct 2023.