Chronic Low Back PainNCT01704677
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
A study testing Lumbar total disc replacement and Multidisciplinary rehabilitation in people with Chronic Low Back Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
During the past 25-30 years, surgery with total disc replacement (TDR) has become an option for a selection of patients with chronic low back pain (LBP) traditionally treated conservatively or operated on with spinal fusion. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lumbar total disc replacement and Multidisciplinary rehabilitation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Nov 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 25-55 years
- had low back pain as the main symptom for at least 1 year
- structured physiotherapy or chiropractic treatment for at least 6 months without sufficient effect
- Oswestry Disability Index (ODI) of at least 30
- degenerative intervertebral disc changes in L4/L5 and/or L5/S1.Degeneration had to be restricted to the two lower levels. The following degenerative changes were evaluated: at least 40% reduction of disc height, Modic changes type I and/or II, high-intensity zone in the disc, and morphological changes classified as changes in signal intensity in the disc of grade 3 or 4. The disc was classified as degenerative if the first criteria alone or at least two changes were found on magnetic resonance imaging. The discs were independently classified by two observers (orthopaedic surgeon /radiologist). When in disagreement, the images were classified by a third observer and the outcome decided by simple majority.
Who cannot join
- Generalized chronic pain syndrome (widespread myofascial pain)
- Degeneration established in more than two levels. To be classified as a normal disc, the disc height must not be reduced more than 40% and all other criteria of degenerative disc disease aforementioned must be absent. The classification of a normal disc is performed by two independent observers. If disagreement, the pictures will be classified by a third observer and the outcome decided by simple majority.
- Symptoms of spinal stenosis
- Disc protrusion or recess stenosis with nerve root affection
- Spondylolysis
- Isthmic spondylolisthesis
Show all 14Show fewer
- Arthritis
- Former fracture of L1 - S1
- Ongoing psychiatric or somatic disease that excludes either one or both treatment alternatives
- Does not understand Norwegian language, spoken or in writing
- Drug abuse
- Osteoporosis
- Congenital or acquired deformity
- Patients were examined by an orthopaedic surgeon and a specialist in physical medicine and rehabilitation together, which had to agree on inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation in Chronic Back Pain and Localized Degenerative Disc. Long Term Follow-up of a Randomized Multicentre Trial
During the past 25-30 years, surgery with total disc replacement (TDR) has become an option for a selection of patients with chronic low back pain (LBP) traditionally treated conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion have found the clinical outcome of TDR at least equivalent to that of fusion, and the only study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years. However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and revision rate, degenerative changes and prognostic factors have not been investigated in high quality prospective trials. This is very much required since TDR surgery is offered a great number of patients world wide, and is associated with high complexity and risk of serious complications and difficult revision. Hence, the overall aim of the present study is to evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low back pain and localized degenerative disc changes.
Read the detailed description
Two-year results of the Norwegian TDR study were published in BMJ in May 2011 (Hellum et al). The current protocol is 8-year follow-up of patients included in the Norwegian TDR study.
Hypothesis of the 8-year follow-up:
Main hypothesis (H0): There are no differences in change between TDR and REHAB for pain and disability measured by Oswestry Disability Index (main outcome), back pain, quality of life, psychological variables, work status, patients satisfaction, drug use, urinary incontinence, and back surgeries after 8 years.
Secondary Hypothesis:
- There are no differences in incidence and degree of disc degeneration at adjacent level or facet joint degeneration at index level between groups (radiological analysis).
- There is no association between baseline characteristics, pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope), and clinical outcome after TDR.
- There is no difference in cost effectiveness between surgery and REHAB 8 years after inclusion to the study.
Statistical analysis:
The investigators will use the same analysis as for 2-years results: two-way ANOVA, mixed model, regression analysis. p<0.05 will be considered statistically significant
Additional analysis (not conducted at 2 years):
- cross-overs will receive last value before cross-over/fusion surgery
- survival analysis
- pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope) will be included in the predictor analysis
- Both CT scans and MRI are taken for the evaluation of index level facet arthropathy
- Conditions
- Chronic Low Back Pain
- Being tested
- Lumbar total disc replacement, Multidisciplinary rehabilitation
- Keywords
- Chronic low back pain, Degenerated disc, Total disc replacement, Multidisciplinary rehabilitation, Long term results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar total disc replacementProcedure or surgery
Also called ProDisc II, Synthes Spine
The surgical intervention consisted of replacement of the degenerative intervertebral lumbar disc with a artificial lumbar disc device in one or two of the lover lumbal levels (L4/L5 or/and L5/S1). The ProDisc consists of three pieces, two metal endplates and a polyethylene core that is fixed to the inferior endplate when the device is implanted, and is implanted through a retroperitoneal (or transperitoneal) access.
Multidisciplinary rehabilitationBehavioural
The intervention is based on a treatment model described by Brox et al (Spine 2003;28:1913-1921) and is also described in details by Hellum et al (BMJ, May 2011). It consisted of a cognitive approach and supervised physical exercise and was delivered by a team of physiotherapists and specialists in physical medicine and rehabilitation. The rehabilitation programme lasted for about 60 hours over three to five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Replacement of the degenerative intervertebral lumbar disc with an artificial lumbar disc device (degeneration had to be restricted to the two lower levels (L4/L5 and/or L5/S1)) Receives: Procedure: Lumbar total disc replacement |
| Multidiciplinary rehabilitation | Active comparator | Not described Receives: Behavioral: Multidisciplinary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Oswestry Disability Index
Version 2.0
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Secondary outcomes (12)
Low back pain
Measured by a VAS scale (0-100 mm)
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
EQ-5D
general health status
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
HSCL-25
Hopkins Symptom Check List 25 for emotional distress
Measured: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Work status
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Satisfaction with treatment outcome
7 point Likert scale
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Satisfaction with care
5 point Likert scale
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial
Drug consumption
Daily, weekly, type
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Urinary incontinence
Stress incontinence, urge incontinence
Measured: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Back surgeries and multidisciplinary rehabilitation
All surgeries and multidisciplinary rehabilitation due to low back pain will be registered
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Disc degeneration
Disc degeneration at adjacent level
Measured: Baseline, 2 and 8 years after inclusion to trial
Facet joint degeneration
Facet joint degeneration at index level
Measured: Baseline, 2 and 8 years after inclusion to trial
Cost-effectiveness
The EQ-5D questionnaire will be used to estimate patient utilities
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital of North Norway
- Responsible party
- Principal investigator, Kjersti Storheim, Oslo University Hospital
- Investigators
- Kjersti Storheim, PhD, Principal investigator, Oslo University Hospital Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704677
- Sponsor's protocol ID
- 2011/2177
- Status last verified
- Jan 2016
- First submitted
- 2 Oct 2012
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Sandvik L, Grundnes O; Norwegian Spine Study Group. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011 May 19;342:d2786. doi: 10.1136/bmj.d2786.
PubMed 21596740Hellum C, Johnsen LG, Gjertsen O, Berg L, Neckelmann G, Grundnes O, Rossvoll I, Skouen JS, Brox JI, Storheim K; Norwegian Spine Study Group. Predictors of outcome after surgery with disc prosthesis and rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up. Eur Spine J. 2012 Apr;21(4):681-90. doi: 10.1007/s00586-011-2145-3. Epub 2012 Jan 13.
PubMed 22246644Hellum C, Berg L, Gjertsen O, Johnsen LG, Neckelmann G, Storheim K, Keller A, Grundnes O, Espeland A; Norwegian Spine Study Group. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2063-73. doi: 10.1097/BRS.0b013e318263cc46.
PubMed 22706091Johnsen LG, Hellum C, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Andresen H, Lydersen S, Grundnes O, Pedersen M, Leivseth G, Olafsson G, Borgstrom F, Fritzell P; Norwegian Spine Study Group. Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT. Spine (Phila Pa 1976). 2014 Jan 1;39(1):23-32. doi: 10.1097/BRS.0000000000000065.
PubMed 24150435Berg L, Hellum C, Gjertsen O, Neckelmann G, Johnsen LG, Storheim K, Brox JI, Eide GE, Espeland A; Norwegian Spine Study Group. Do more MRI findings imply worse disability or more intense low back pain? A cross-sectional study of candidates for lumbar disc prosthesis. Skeletal Radiol. 2013 Nov;42(11):1593-602. doi: 10.1007/s00256-013-1700-x. Epub 2013 Aug 28.
PubMed 23982421Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148.
PubMed 23622053Johnsen LG, Brinckmann P, Hellum C, Rossvoll I, Leivseth G. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation. Bone Joint J. 2013 Jan;95-B(1):81-9. doi: 10.1302/0301-620X.95B1.29829.
PubMed 23307678Berg L, Gjertsen O, Hellum C, Neckelmann G, Johnsen LG, Eide GE, Espeland A. Reliability of change in lumbar MRI findings over time in patients with and without disc prosthesis--comparing two different image evaluation methods. Skeletal Radiol. 2012 Dec;41(12):1547-57. doi: 10.1007/s00256-012-1394-5. Epub 2012 Mar 20.
PubMed 22430564Garratt AM, Furunes H, Hellum C, Solberg T, Brox JI, Storheim K, Johnsen LG. Evaluation of the EQ-5D-3L and 5L versions in low back pain patients. Health Qual Life Outcomes. 2021 May 28;19(1):155. doi: 10.1186/s12955-021-01792-y.
PubMed 34049574
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation in Chronic Back Pain and Localized Degenerative Disc. Long Term Follow-up of a Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT01704677
- Acronym / sponsor ID
- 2011/2177
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Degenerated disc, Total disc replacement, Multidisciplinary rehabilitation, Long term results
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital of North Norway
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Oct 2012 (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.
During the past 25-30 years, surgery with total disc replacement (TDR) has become an option for a selection of patients with chronic low back pain (LBP) traditionally treated conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion have found the clinical outcome of TDR at least equivalent to that of fusion, and the only study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years. However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and revision rate, degenerative changes and prognostic factors have not been investigated in high quality prospective trials. This is very much required since TDR surgery is offered a great number of patients world wide, and is associated with high complexity and risk of serious complications and difficult revision. Hence, the overall aim of the present study is to evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low back pain and localized degenerative disc changes.
Detailed description
Two-year results of the Norwegian TDR study were published in BMJ in May 2011 (Hellum et al). The current protocol is 8-year follow-up of patients included in the Norwegian TDR study.
Hypothesis of the 8-year follow-up:
Main hypothesis (H0): There are no differences in change between TDR and REHAB for pain and disability measured by Oswestry Disability Index (main outcome), back pain, quality of life, psychological variables, work status, patients satisfaction, drug use, urinary incontinence, and back surgeries after 8 years.
Secondary Hypothesis:
- There are no differences in incidence and degree of disc degeneration at adjacent level or facet joint degeneration at index level between groups (radiological analysis).
- There is no association between baseline characteristics, pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope), and clinical outcome after TDR.
- There is no difference in cost effectiveness between surgery and REHAB 8 years after inclusion to the study.
Statistical analysis:
The investigators will use the same analysis as for 2-years results: two-way ANOVA, mixed model, regression analysis. p<0.05 will be considered statistically significant
Additional analysis (not conducted at 2 years):
- cross-overs will receive last value before cross-over/fusion surgery
- survival analysis
- pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope) will be included in the predictor analysis
- Both CT scans and MRI are taken for the evaluation of index level facet arthropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Lumbar total disc replacementReplacement of the degenerative intervertebral lumbar disc with an artificial lumbar disc device (degeneration had to be restricted to the two lower levels (L4/L5 and/or L5/S1)) |
| Multidiciplinary rehabilitation | Active comparator | Behavioral: Multidisciplinary rehabilitation |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 25-55 years
- had low back pain as the main symptom for at least 1 year
- structured physiotherapy or chiropractic treatment for at least 6 months without sufficient effect
- Oswestry Disability Index (ODI) of at least 30
- degenerative intervertebral disc changes in L4/L5 and/or L5/S1.Degeneration had to be restricted to the two lower levels. The following degenerative changes were evaluated: at least 40% reduction of disc height, Modic changes type I and/or II, high-intensity zone in the disc, and morphological changes classified as changes in signal intensity in the disc of grade 3 or 4. The disc was classified as degenerative if the first criteria alone or at least two changes were found on magnetic resonance imaging. The discs were independently classified by two observers (orthopaedic surgeon /radiologist). When in disagreement, the images were classified by a third observer and the outcome decided by simple majority.
Key exclusion criteria (14 listed)
- Generalized chronic pain syndrome (widespread myofascial pain)
- Degeneration established in more than two levels. To be classified as a normal disc, the disc height must not be reduced more than 40% and all other criteria of degenerative disc disease aforementioned must be absent. The classification of a normal disc is performed by two independent observers. If disagreement, the pictures will be classified by a third observer and the outcome decided by simple majority.
- Symptoms of spinal stenosis
- Disc protrusion or recess stenosis with nerve root affection
- Spondylolysis
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 |
|---|---|---|
| Lumbar total disc replacementAlso: ProDisc II, Synthes SpineThe surgical intervention consisted of replacement of the degenerative intervertebral lumbar disc with a artificial lumbar disc device in one or two of the lover lumbal levels (L4/L5 or/and L5/S1). The ProDisc consists of three pieces, two metal endplates and a polyethylene core that is fixed to the inferior endplate when the device is implanted, and is implanted through a retroperitoneal (or transperitoneal) access. | Procedure or surgery | Surgery |
| Multidisciplinary rehabilitationThe intervention is based on a treatment model described by Brox et al (Spine 2003;28:1913-1921) and is also described in details by Hellum et al (BMJ, May 2011). It consisted of a cognitive approach and supervised physical exercise and was delivered by a team of physiotherapists and specialists in physical medicine and rehabilitation. The rehabilitation programme lasted for about 60 hours over three to five weeks. | Behavioural | Multidiciplinary rehabilitation |
Primary outcome
Oswestry Disability Index Oswestry Disability Index
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Version 2.0
12 secondary outcomes
Low back pain
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
EQ-5D
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
HSCL-25
Time frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Work status
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Satisfaction with treatment outcome
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Satisfaction with care
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial
Drug consumption
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Urinary incontinence
Time frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Back surgeries and multidisciplinary rehabilitation
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Disc degeneration
Time frame: Baseline, 2 and 8 years after inclusion to trial
Facet joint degeneration
Time frame: Baseline, 2 and 8 years after inclusion to trial
Cost-effectiveness
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
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 20 Jan 2016.
- Background: PubMed 21596740Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Sandvik L, Grundnes O; Norwegian Spine Study Group. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011 May 19;342:d2786. doi: 10.1136/bmj.d2786.
- Background: PubMed 22246644Hellum C, Johnsen LG, Gjertsen O, Berg L, Neckelmann G, Grundnes O, Rossvoll I, Skouen JS, Brox JI, Storheim K; Norwegian Spine Study Group. Predictors of outcome after surgery with disc prosthesis and rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up. Eur Spine J. 2012 Apr;21(4):681-90. doi: 10.1007/s00586-011-2145-3. Epub 2012 Jan 13.
- Background: PubMed 22706091Hellum C, Berg L, Gjertsen O, Johnsen LG, Neckelmann G, Storheim K, Keller A, Grundnes O, Espeland A; Norwegian Spine Study Group. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2063-73. doi: 10.1097/BRS.0b013e318263cc46.
- Background: PubMed 24150435Johnsen LG, Hellum C, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Andresen H, Lydersen S, Grundnes O, Pedersen M, Leivseth G, Olafsson G, Borgstrom F, Fritzell P; Norwegian Spine Study Group. Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT. Spine (Phila Pa 1976). 2014 Jan 1;39(1):23-32. doi: 10.1097/BRS.0000000000000065.
- Background: PubMed 23982421Berg L, Hellum C, Gjertsen O, Neckelmann G, Johnsen LG, Storheim K, Brox JI, Eide GE, Espeland A; Norwegian Spine Study Group. Do more MRI findings imply worse disability or more intense low back pain? A cross-sectional study of candidates for lumbar disc prosthesis. Skeletal Radiol. 2013 Nov;42(11):1593-602. doi: 10.1007/s00256-013-1700-x. Epub 2013 Aug 28.
- Background: PubMed 23622053Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148.
- Background: PubMed 23307678Johnsen LG, Brinckmann P, Hellum C, Rossvoll I, Leivseth G. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation. Bone Joint J. 2013 Jan;95-B(1):81-9. doi: 10.1302/0301-620X.95B1.29829.
- Background: PubMed 22430564Berg L, Gjertsen O, Hellum C, Neckelmann G, Johnsen LG, Eide GE, Espeland A. Reliability of change in lumbar MRI findings over time in patients with and without disc prosthesis--comparing two different image evaluation methods. Skeletal Radiol. 2012 Dec;41(12):1547-57. doi: 10.1007/s00256-012-1394-5. Epub 2012 Mar 20.
- Derived from this study: PubMed 34049574Garratt AM, Furunes H, Hellum C, Solberg T, Brox JI, Storheim K, Johnsen LG. Evaluation of the EQ-5D-3L and 5L versions in low back pain patients. Health Qual Life Outcomes. 2021 May 28;19(1):155. doi: 10.1186/s12955-021-01792-y.
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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.
Kjersti Storheim, PhD principal investigator
Oslo University Hospital Ullevål
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar total disc replacement and Multidisciplinary rehabilitation in people with Chronic Low Back Pain, run by Oslo University Hospital at 1 site in Norway.
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 5 inclusion and 14 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 20 Jan 2016. 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 Norway. 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?
Oswestry Disability Index Oswestry Disability Index (time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial). 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 NCT01704677, which also lists 9 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 20 Jan 2016.