ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

2 year

Secondary outcome [1]

Oswestry Disability Index

Timepoint [1]

2 year

Secondary outcome [2]

Visual analogue scale for back-and leg pain.

Timepoint [2]

2 year

Secondary outcome [3]

General function score

Timepoint [3]

2 year

Secondary outcome [4]

Zung depression score

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/1992

Actual

1/01/1992

Date of last participant enrolment

Anticipated

31/12/1998

Actual

31/12/1998

Date of last data collection

Anticipated

Actual

Sample size

Target

294

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sweden

State/province [1]

Gothenburg

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Acromed Corporation

Address [1]

Acromed Corporation
325 Paramount Drive
Raynham
Massachusetts
02767

Country [1]

United States of America

Funding source category [2]

Commercial sector/Industry

Name [2]

Ossano Scandinavia AB

Address [2]

Ossano Scandinavia AB
Djurgardsslatten 96
S-115 21 Stockholm

Country [2]

Sweden

Primary sponsor type

Hospital

Name

Sahlgrenska University Hospital

Address

Sahlgrenska Universitetssjukhuset
Bruna Straket 11b
413 45 Gothenburg

Country

Sweden

Secondary sponsor category [1]

Hospital

Name [1]

Falun County Hospital

Address [1]

Falun County Hospital
Vasag. 27
791 37 FALUN

Country [1]

Sweden

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Regional Ethic Committee in Gothenburg

Ethics committee address [1]

Box 410, 404 30 Gothenburg

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

12/03/1991

Approval date [1]

22/05/1991

Ethics approval number [1]

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

Prof Rune Hedlund

Address

Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg

Country

Sweden

Phone

+46707958515

Fax

rune.hedlund@vgregion.se

Contact person for public queries

Name

Christer Johansson

Address

Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg

Country

Sweden

Phone

+46701406266

Fax

bc.chaplin@gmail.com

Contact person for scientific queries

Name

Christer Johansson

Address

Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg

Country

Sweden

Phone

+46313434060

Fax

bc.chaplin@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The long-term outcome of lumbar fusion in the Swedish lumbar spine study.	2016	https://dx.doi.org/10.1016/j.spinee.2015.08.065

N.B. These documents automatically identified may not have been verified by the study sponsor.

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