Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lumbar total disc replacement
Multidisciplinary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Degenerated disc, Total disc replacement, Multidisciplinary rehabilitation, Long term results
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Oslo University Hospital Ullevål
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgery
Multidiciplinary rehabilitation
Arm Description
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))
Outcomes
Primary Outcome Measures
Oswestry Disability Index Oswestry Disability Index
Version 2.0
Secondary Outcome Measures
Low back pain
Measured by a VAS scale (0-100 mm)
EQ-5D
general health status
HSCL-25
Hopkins Symptom Check List 25 for emotional distress
Work status
Satisfaction with treatment outcome
7 point Likert scale
Satisfaction with care
5 point Likert scale
Drug consumption
Daily, weekly, type
Urinary incontinence
Stress incontinence, urge incontinence
Back surgeries and multidisciplinary rehabilitation
All surgeries and multidisciplinary rehabilitation due to low back pain will be registered
Disc degeneration
Disc degeneration at adjacent level
Facet joint degeneration
Facet joint degeneration at index level
Cost-effectiveness
The EQ-5D questionnaire will be used to estimate patient utilities
Full Information
NCT ID
NCT01704677
First Posted
October 2, 2012
Last Updated
January 18, 2016
Sponsor
Oslo University Hospital
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT01704677
Brief Title
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
St. Olavs Hospital, Haukeland University Hospital, Helse Stavanger HF, University Hospital of North Norway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain, Degenerated disc, Total disc replacement, Multidisciplinary rehabilitation, Long term results
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
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))
Arm Title
Multidiciplinary rehabilitation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lumbar total disc replacement
Other Intervention Name(s)
ProDisc II, Synthes Spine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Disability Index Oswestry Disability Index
Description
Version 2.0
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Secondary Outcome Measure Information:
Title
Low back pain
Description
Measured by a VAS scale (0-100 mm)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
EQ-5D
Description
general health status
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
HSCL-25
Description
Hopkins Symptom Check List 25 for emotional distress
Time Frame
Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Work status
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Satisfaction with treatment outcome
Description
7 point Likert scale
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Satisfaction with care
Description
5 point Likert scale
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial
Title
Drug consumption
Description
Daily, weekly, type
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Urinary incontinence
Description
Stress incontinence, urge incontinence
Time Frame
Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Back surgeries and multidisciplinary rehabilitation
Description
All surgeries and multidisciplinary rehabilitation due to low back pain will be registered
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Title
Disc degeneration
Description
Disc degeneration at adjacent level
Time Frame
Baseline, 2 and 8 years after inclusion to trial
Title
Facet joint degeneration
Description
Facet joint degeneration at index level
Time Frame
Baseline, 2 and 8 years after inclusion to trial
Title
Cost-effectiveness
Description
The EQ-5D questionnaire will be used to estimate patient utilities
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
Other Pre-specified Outcome Measures:
Title
Time to surgery
Description
For patients randomized to TDR surgery: time to fixation
For patients randomized to REHAB: time to TDR surgery or fixation
Time Frame
From baseline to 8 years after inclusion to the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjersti Storheim, PhD
Organizational Affiliation
Oslo University Hospital Ullevål
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21596740
Citation
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.
Results Reference
background
PubMed Identifier
22246644
Citation
Hellum 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.
Results Reference
background
PubMed Identifier
22706091
Citation
Hellum 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.
Results Reference
background
PubMed Identifier
24150435
Citation
Johnsen 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.
Results Reference
background
PubMed Identifier
23982421
Citation
Berg 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.
Results Reference
background
PubMed Identifier
23622053
Citation
Johnsen 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.
Results Reference
background
PubMed Identifier
23307678
Citation
Johnsen 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.
Results Reference
background
PubMed Identifier
22430564
Citation
Berg 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.
Results Reference
background
PubMed Identifier
34049574
Citation
Garratt 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.
Results Reference
derived
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Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
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