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Trial registered on ANZCTR


Registration number
ACTRN12615000162516
Ethics application status
Approved
Date submitted
15/12/2014
Date registered
19/02/2015
Date last updated
19/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.
Scientific title
Effect of lumbar fusion versus nonsurgical treatment on pain and function in patients with chronic low back pain
Secondary ID [1] 285852 0
Nil
Universal Trial Number (UTN)
U1111-1165-2482
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 293765 0
Condition category
Condition code
Musculoskeletal 294067 294067 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal fusion is surgery to permanently connect two or more vertebrae in your spine, eliminating motion between them.

Spinal fusion involves techniques designed to mimic the normal healing process of broken bones. During spinal fusion, the surgeon places bone or a bone-like material in the space between two spinal vertebrae. Metal plates, screws and rods may be used to hold the vertebrae together, so they can heal into one solid unit. The procedure takes approximate 1-3 hours to complete.
Intervention code [1] 290830 0
Treatment: Surgery
Comparator / control treatment
A nonsurgical treatment program was constructed on a consensus basis to serve as a guideline within the study. The main component was physical therapy, which could be supplemented with other forms of treatment, such as information and education, treatment aimed at pain relief (TENS, acupuncture, injections), cognitive and functional training, and coping strategies. Thus, the treatment could vary within broad but commonly used limits reflecting the nonsurgical treatment policy in the society.
Control group
Active

Outcomes
Primary outcome [1] 293851 0
Patient overall assessment. The result, according to the patient’s own opinion, was reflected in response to the question, “Compared with before treatment my back problems are: ‘much better, better, unchanged, or worse’.”
Timepoint [1] 293851 0
2 year
Secondary outcome [1] 311985 0
Oswestry Disability Index
Timepoint [1] 311985 0
2 year
Secondary outcome [2] 311986 0
Visual analogue scale for back-and leg pain.
Timepoint [2] 311986 0
2 year
Secondary outcome [3] 311987 0
General function score
Timepoint [3] 311987 0
2 year
Secondary outcome [4] 311988 0
Zung depression score
Timepoint [4] 311988 0
2 year

Eligibility
Key inclusion criteria
Patients with chronic low back pain for at least 2 years and with radiologic evidence of disc degeneration at L4-L5 or L5-S1. Back pain more pronounced than leg pain and no signs of nerve root compression. The patients must have been on sick leave for at least 1 year and nonsurgical treatment efforts should have been unsuccessful.
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ongoing psychiatric illness.
Previous spine surgery except for successful removal of herniated disc.
Infection or inflammatory process.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was off-site at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The size of the study was based on the following assumptions: 1) The primary aim was to compare nonsurgical and surgical treatment. 2). Outcome was estimated as either an essential improvement (1) or as no essential improvement (0) after 2 years. This was analogous to one of the primary outcome measures used in the study, where the result was assessed by the patient as an improvement expressed as either “much better” or better”(1), or as no improvement expressed as “unchanged” or “worse”(0); 3) “Essential improvement” was assumed to occur in 5% of the patients in the nonsurgically treated group; 4) The probability of detecting a statistically significant difference (power) between the main groups should be at least 80%; 5) Calculations were performed with the Fisher’s exact test (two-sided) and a significance level of 0.05; and 6) We decided to include 225 in the surgical group and 75 in the control group (3:1)). This size basically implied that we would achieve a significant difference (with 80% power) even if only 18% of the patients in a surgical group compared with 5% in a nonsurgical group should be essentially improved. Thus, we considered the suggested sample size being sufficient to detect an assumed clinically relevant difference or 13% (18-5) expressed as “essential improvement” between the two main groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6549 0
Sweden
State/province [1] 6549 0
Gothenburg

Funding & Sponsors
Funding source category [1] 290422 0
Commercial sector/Industry
Name [1] 290422 0
Acromed Corporation
Address [1] 290422 0
Acromed Corporation
325 Paramount Drive
Raynham
Massachusetts
02767
Country [1] 290422 0
United States of America
Funding source category [2] 290423 0
Commercial sector/Industry
Name [2] 290423 0
Ossano Scandinavia AB
Address [2] 290423 0
Ossano Scandinavia AB
Djurgardsslatten 96
S-115 21 Stockholm
Country [2] 290423 0
Sweden
Primary sponsor type
Hospital
Name
Sahlgrenska University Hospital
Address
Sahlgrenska Universitetssjukhuset
Bruna Straket 11b
413 45 Gothenburg
Country
Sweden
Secondary sponsor category [1] 289137 0
Hospital
Name [1] 289137 0
Falun County Hospital
Address [1] 289137 0
Falun County Hospital
Vasag. 27
791 37 FALUN
Country [1] 289137 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292108 0
Regional Ethic Committee in Gothenburg
Ethics committee address [1] 292108 0
Box 410, 404 30 Gothenburg
Ethics committee country [1] 292108 0
Sweden
Date submitted for ethics approval [1] 292108 0
12/03/1991
Approval date [1] 292108 0
22/05/1991
Ethics approval number [1] 292108 0
108-91

Summary
Brief summary
To determine whether fusion of the lower lumbar spine could reduce pain and diminish disability when compared with nonsurgical treatment in patients with chronic low back pain.
Trial website
Trial related presentations / publications
Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. PubMed PMID: 11725230.

Hagg O, Fritzell P, Romberg K, Nordwall A. The General Function Score: a useful tool for measurement of physical disability. Validity and reliability. Eur Spine J. 2001 Jun;10(3):203-10. PubMed PMID: 11469730; PubMed Central PMCID: PMC3611492.

Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1131-41. PubMed PMID: 12045508.

Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. Characteristics of patients with chronic low back pain selected for surgery: a comparison with the general population reported from the Swedish lumbar spine study. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1223-31. PubMed PMID: 12045521.

Hagg O, Fritzell P, Oden A, Nordwall A; Swedish Lumbar Spine Study Group. Simplifying outcome measurement: evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1213-22. PubMed PMID: 12045520.

Hagg O, Fritzell P, Ekselius L, Nordwall A; Swedish Lumbar Spine Study. Predictors of outcome in fusion surgery for chronic low back pain. A report from the Swedish Lumbar Spine Study. Eur Spine J. 2003 Feb;12(1):22-33. Epub 2002 Oct 23. PubMed PMID: 12592544.

Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. Epub 2002 Oct 24. PubMed PMID: 12592542.

Hagg O, Fritzell P, Hedlund R, Moller H, Ekselius L, Nordwall A; Swedish Lumbar Spine Study. Pain-drawing does not predict the outcome of fusion surgery for chronic low-back pain: a report from the Swedish Lumbar Spine Study. Eur Spine J. 2003 Feb;12(1):2-11. Epub 2002 Jun 21. PubMed PMID: 12592541.

Fritzell P, Hagg O, Nordwall A; Swedish Lumbar Spine Study Group. Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group. Eur Spine J. 2003 Apr;12(2):178-89. Epub 2003 Feb 14. PubMed PMID: 12709856; PubMed Central PMCID: PMC3784840.

Fritzell P, Hagg O, Jonsson D, Nordwall A; Swedish Lumbar Spine Study Group. Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2004 Feb 15;29(4):421-34; discussion Z3. PubMed PMID: 15094539.

Mannion AF, Leivseth G, Brox JI, Fritzell P, Hagg O, Fairbank JC. ISSLS Prize winner: Long-term follow-up suggests spinal fusion is associated with increased adjacent segment disc degeneration but without influence on clinical outcome: results of a combined follow-up from 4 randomized controlled trials. Spine (Phila Pa 1976). 2014 Aug 1;39(17):1373-83. doi: 10.1097/BRS.0000000000000437. PubMed PMID: 24859589.
Public notes

Contacts
Principal investigator
Name 53554 0
Prof Rune Hedlund
Address 53554 0
Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg
Country 53554 0
Sweden
Phone 53554 0
+46707958515
Fax 53554 0
Email 53554 0
rune.hedlund@vgregion.se
Contact person for public queries
Name 53555 0
Mr Christer Johansson
Address 53555 0
Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg
Country 53555 0
Sweden
Phone 53555 0
+46701406266
Fax 53555 0
Email 53555 0
bc.chaplin@gmail.com
Contact person for scientific queries
Name 53556 0
Mr Christer Johansson
Address 53556 0
Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg
Country 53556 0
Sweden
Phone 53556 0
+46313434060
Fax 53556 0
Email 53556 0
bc.chaplin@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary