Low Back PainNCT00454792
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
A study testing Exercise and Restitution in people with Low Back Pain, run by The Back Research Center, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe: 1. To compare the effect of two types of non-operative treatments: A. exercise and advice to be physically active B. restitution and advice not to overload the spine 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise and Restitution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Sep 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary inclusion criteria for receiving MRI
- The patient must have LBP with a current duration of 3 - 12 month.
- The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.
- Secondary inclusion criteria for receiving MRI
- The patient must speak and understand Danish.
- The patient must be between 18-60 years of age.
- The patient must be willing to participate in the project. Inclusions criterium for the project
- There must be an MRI showing MC in the lumbar spine.
Who cannot join
- The patient is unable to go through with the project because of other physical or mental disorder.
- The patient is pregnant.
- The patient is referred to operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:
- To compare the effect of two types of non-operative treatments:
- exercise and advice to be physically active
- restitution and advice not to overload the spine
- To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.
Read the detailed description
The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.
- Conditions
- Low Back Pain
- Being tested
- Exercise, Restitution
- Keywords
- Low back pain, Modic changes
- 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.
ExerciseOther
Back exercise: At home every day. In groups once a week. Duration 10 weeks.
RestitutionOther
Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and advise to stay active | Active comparator | The exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training. Receives: Other: Exercise |
| Rest and use of flexible lumbar belt | Experimental | The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down Receives: Other: Restitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is actual LBP, as measured with an "11 point box scale".
Measured: 10 weeks and 12 months
Secondary outcomes (3)
General Health, as measured with the EQ-5D (EuroQol)
Measured: 10 weeks and 12 months
General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
Measured: 10 weeks and 12 months
Physical functions measured with "Roland Morris Disability Questionnaire"
Measured: 10 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Back Research Center, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden
- Responsible party
- Principal investigator, Rikke Krüger Jensen, The Back Research Center, Denmark
- Investigators
- Claus Manniche, Prof.Dr.Med., Study chair, Spine Centre of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454792
- Sponsor's protocol ID
- VF-20060111
- Status last verified
- Sep 2011
- First submitted
- 30 Mar 2007
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.
PubMed 22376791
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00454792
- Acronym / sponsor ID
- VF-20060111
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Modic changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Back Research Center, DenmarkUniversity, hospital or other
- Collaborators
- Velux Fonden
- Study start
- Mar 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Apr 2007 (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 purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:
- To compare the effect of two types of non-operative treatments:
- exercise and advice to be physically active
- restitution and advice not to overload the spine
- To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.
Detailed description
The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and advise to stay active | Active comparator | Other: ExerciseThe exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training. |
| Rest and use of flexible lumbar belt | Experimental | Other: RestitutionThe rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primary inclusion criteria for receiving MRI
- The patient must have LBP with a current duration of 3 - 12 month.
- The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.
- Secondary inclusion criteria for receiving MRI
- The patient must speak and understand Danish.
Key exclusion criteria (3 listed)
- The patient is unable to go through with the project because of other physical or mental disorder.
- The patient is pregnant.
- The patient is referred to operation.
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 |
|---|---|---|
| ExerciseBack exercise: At home every day. In groups once a week. Duration 10 weeks. | Other | Exercise and advise to stay active |
| RestitutionRestitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks. | Other | Rest and use of flexible lumbar belt |
Primary outcome
The primary outcome measure is actual LBP, as measured with an "11 point box scale".
Time frame: 10 weeks and 12 months
3 secondary outcomes
General Health, as measured with the EQ-5D (EuroQol)
Time frame: 10 weeks and 12 months
General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
Time frame: 10 weeks and 12 months
Physical functions measured with "Roland Morris Disability Questionnaire"
Time frame: 10 weeks and 12 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 26 Sep 2011.
- Derived from this study: PubMed 22376791Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.
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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.
Claus Manniche, Prof.Dr.Med. study chair
Spine Centre of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Restitution in people with Low Back Pain, run by The Back Research Center, Denmark 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 8 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 26 Sep 2011. 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 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?
The primary outcome measure is actual LBP, as measured with an "11 point box scale". (time frame: 10 weeks and 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 NCT00454792, which also lists 1 linked publication.
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 26 Sep 2011.