Fritzell, Spine (Phila Pa 1976) 2001 - 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
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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
Fritzell, Swedish Lumbar Spine Study Group, et al.·Spine (Phila Pa 1976)·2001·920 citations·RCT
Fritzell and colleagues tested whether lower lumbar fusion relieves pain and disability more than nonsurgical treatment in severe chronic low back pain.
Swedish 19‑center randomized trial of 294 patients aged 25 to 65 with chronic low back pain for at least 2 years, referred 1992 to 1998 and followed for 2 years.
Methods
Design
Randomized controlled trial
Referred 1992 to 1998
Assessment by an independent observer
Setting
19 spinal centers in Sweden
Patients
294 randomized
Age 25 to 65
Chronic low back pain ≥ 2 years
Disc degeneration at L4‑L5, L5‑S1 or both
Mean pain duration 7.8 years (fusion) vs 8.5 years (nonsurgical)
Mean sick leave 3.2 years (fusion) vs 2.9 years (nonsurgical)
Groups
Fusion, three techniques pooled (n = 222)
Physical therapy of various kinds (n = 72)
Follow-up
2 years
289 of 294 (98%) examined, including 25 who changed groups
Analyzed by intention to treat
Outcomes
Back pain on VAS
Disability on Oswestry, Million and GFS
Depressive symptoms on Zung
Overall result rated by patient and independent observer
Work disability from Swedish Social Insurance records
Key Findings
At 2 years, back pain on VAS fell 33% (64 to 43) after fusion vs 7% (63 to 58) after physical therapy (p = 0.0002).
Disability improved more with fusion on all three scales: Oswestry 25% vs 6% (p = 0.015), Million 28% vs 8% (p = 0.004) and GFS 31% vs 4% (p = 0.005).
63% of fusion patients (122 of 195) rated themselves better or much better, vs 29% of nonsurgical patients (18 of 62) (p < 0.0001).
The net back‑to‑work rate was 36% after fusion vs 13% after nonsurgical care (p = 0.002).
Pain relief after fusion was greatest by 6 months, and back pain then rose significantly between 1 and 2 years (p = 0.0001).
An early complication occurred in 17% of the surgical group, and 6% of pedicle screw patients (9 of 140) had new nerve root pain.
Board pearl
Radiographic fusion was seen in 83% of operated patients, yet fusion status did not correlate with improvement in pain, disability or the patient's overall rating.
Authors' conclusion
Lumbar fusion in a well-informed and selected group of patients with severe CLBP can diminish pain and decrease disability more efficiently than commonly used nonsurgical treatment.
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
Fritzell, Swedish Lumbar Spine Study Group, et al.·Spine (Phila Pa 1976)·2001·920 citations·RCT
Fritzell and colleagues tested whether lower lumbar fusion relieves pain and disability more than nonsurgical treatment in severe chronic low back pain.
Swedish 19‑center randomized trial of 294 patients aged 25 to 65 with chronic low back pain for at least 2 years, referred 1992 to 1998 and followed for 2 years.
Methods
Design
Randomized controlled trial
Referred 1992 to 1998
Assessment by an independent observer
Setting
19 spinal centers in Sweden
Patients
294 randomized
Age 25 to 65
Chronic low back pain ≥ 2 years
Disc degeneration at L4‑L5, L5‑S1 or both
Mean pain duration 7.8 years (fusion) vs 8.5 years (nonsurgical)
Mean sick leave 3.2 years (fusion) vs 2.9 years (nonsurgical)
Groups
Fusion, three techniques pooled (n = 222)
Physical therapy of various kinds (n = 72)
Follow-up
2 years
289 of 294 (98%) examined, including 25 who changed groups
Analyzed by intention to treat
Outcomes
Back pain on VAS
Disability on Oswestry, Million and GFS
Depressive symptoms on Zung
Overall result rated by patient and independent observer
Work disability from Swedish Social Insurance records
Key Findings
At 2 years, back pain on VAS fell 33% (64 to 43) after fusion vs 7% (63 to 58) after physical therapy (p = 0.0002).
Disability improved more with fusion on all three scales: Oswestry 25% vs 6% (p = 0.015), Million 28% vs 8% (p = 0.004) and GFS 31% vs 4% (p = 0.005).
63% of fusion patients (122 of 195) rated themselves better or much better, vs 29% of nonsurgical patients (18 of 62) (p < 0.0001).
The net back‑to‑work rate was 36% after fusion vs 13% after nonsurgical care (p = 0.002).
Pain relief after fusion was greatest by 6 months, and back pain then rose significantly between 1 and 2 years (p = 0.0001).
An early complication occurred in 17% of the surgical group, and 6% of pedicle screw patients (9 of 140) had new nerve root pain.
Board pearl
Radiographic fusion was seen in 83% of operated patients, yet fusion status did not correlate with improvement in pain, disability or the patient's overall rating.
Authors' conclusion
Lumbar fusion in a well-informed and selected group of patients with severe CLBP can diminish pain and decrease disability more efficiently than commonly used nonsurgical treatment.