Takaisin Tulosta

Selkärangan luudutusleikkauksen kustannusvaikuttavuus kroonisessa selkäkivussa verrattuna tavanomaiseen tai intensiiviseen kuntoutukseen

Lisätietoa aiheesta
Antti Malmivaara ja Jyrki Salmenkivi
13.5.2008

Luudutusleikkauksella saavutetaan kroonisessa selkäkivussa ilmeisesti parempi vaikuttavuus kuin tavanomaisella kuntoutuksella hieman suuremmilla kustannuksilla.

Luudutusleikkauksella saavutetaan kroonisessa selkäkivussa ilmeisesti samanlainen vaikuttavuus kuin intensiivisellä kuntoutuksella, mutta luudutusleikkauksen terveydenhuollolle aiheuttamat kustannukset ovat ilmeisesti suuremmat.

Luudutusleikkauksen kustannusvaikuttavuudesta kroonisessa selkäkivussa on julkaistu kaksi satunnaistettua vertailututkimusta, ruotsalainen Swedish Lumbar Spine Study «Fritzell P, Hägg O, Wessberg P ym. 2001 Volvo Awar...»1, «Fritzell P, Hägg O, Wessberg P ym. Chronic low bac...»2, «Fritzell P, Hägg O, Wessberg P ym. 2001 Volvo Awar...»3, «Fritzell P, Hägg O, Jonsson D ym. Cost-effectivene...»4 sekä Iso-Britannian Medical Research Councilin (MRC) tutkimus «Fairbank J, Frost H, Wilson-MacDonald J ym. Random...»5. Lisäksi on julkaistu norjalainen tutkimus, jossa on verrattu kirurgiaa ja intensiivistä kuntoutusta mutta tässä ei ole raportoitu kustannuksia.

Swedish Lumbar Spine Study

«Fritzell P, Hägg O, Wessberg P ym. 2001 Volvo Awar...»1, «Fritzell P, Hägg O, Wessberg P ym. Chronic low bac...»2, «Fritzell P, Hägg O, Wessberg P ym. 2001 Volvo Awar...»3, «Fritzell P, Hägg O, Jonsson D ym. Cost-effectivene...»4

Patients: Chronic low back pain patients (N = 294)

Interventions:

Group 1 Posterolateral fusion; n = 73

Group 2 Posterolateral fusion combined with variable screw placement, an internal fixation device; n = 74

Group 3 Posterolateral fusion combined with variable screw placement and interbody fusion; n = 75

Group 4 Conservative treatment; n = 72

Results, effectiveness:

At the 2-year follow-up 289 of 294 (98 %) patients. Back pain was reduced in the surgical group by 33 %, compared with 7 % in the non-surgical group. Oswestry scores reduced by 25 % in the surgical group compared with 6 % in the non-surgical group. In the surgical group, 63 % rated themselves as "much better" or "better" compared with 29 % in the non-surgical group. The "net back to work rate" was significantly in favour of surgical treatment: 36 % vs. 13 %. All surgical techniques were found to reduce pain and decrease disability substantially, but no significant differences were found among the groups. No obvious disadvantage in using the least demanding surgical technique of posterolateral fusion without internal fixation.

Results, costs, cost-effectiveness:

The more demanding techniques in Groups 2 and 3 consumed significantly more resources in terms of operation time, blood transfusions, and days in hospital after surgery. The societal total cost per patient in the surgical group was significantly higher than in the non-surgical group: SEK 704 000 vs. SEK 636 000. The cost per patient for the healthcare sector was significantly higher for the surgical group, SEK 123 000 vs. 65 200 for the non-surgical group. The incremental cost-effectiveness ratios (ICER), illustrating the extra cost per extra effect unit gained by using fusion instead of non-surgical treatment, were: for overall improvement, SEK 2 600; for back pain, SEK 5 200; for Oswestry, SEK 11 300; and for return to work, SEK 4 100.

The authors conclusions:

Both for the society and the healthcare sectors, the 2-year costs for lumbar fusion were significantly higher compared with nonsurgical treatment but all treatment effects were significantly in favour of surgery. The probability of lumbar fusion being cost-effective increased with the value put on extra effect units gained by using surgery. Using the non-instrumented PLF as a reference, costs increased by 66 % when instrumentation was added, and 103 % if an interbody procedure was also performed.

Tutkimuksen laatu: tasokas

Sovellettavuus Suomeen: vaikuttavuus: hyvä, kustannusvaikuttavuus: kohtalainen

UK Medical Research Council trial

«Fairbank J, Frost H, Wilson-MacDonald J ym. Random...»5

Patients: Chronic low back pain patients (N = 349)

Interventions:

Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy.

Results, effectiveness:

At the 2-year follow-up there was no clinical or statistical difference in outcome (pain, Oswestry disability, quality of life, SF36 physical or mental components) between spinal fusion and an intensive 3-week (15 day) programme of exercise therapy, spine stabilisation exercises and education using cognitive-behavioural principles.

Results, costs, cost-effectiveness:

In the MRC trial, at the 2-year follow-up, the treatment costs of the surgery arm were approximately twice those of the conservative arm. The costs of conservative treatment depend on how many patients opt for surgery afterwards (22 % in this trial).

Results, adverse effects:

Complication rate after surgery has been reported to be around 17–18 % (6 to 31 % depending on technique) with a 6–22 % re-intervention rate; however, in the trials examined, 4–22 % of patients allocated to the non-surgical treatment arms also underwent surgery.

Tutkimuksen laatu: tasokas

Sovellettavuus Suomeen: vaikuttavuus: hyvä, kustannusvaikuttavuus: kohtalainen

Kommentteja:Eurooppalainen hoitosuositusryhmä on päätynyt seuraaviin yhteenvetoihin.

Vaikuttavuus:

European Guidelines Group's «Airaksinen O, Brox JL, Cedraschi C ym. COST B13 Wo...»7 Evidence Summary (includes a Norweigian effectiveness study «Brox JI. Randomized clinical trial of lumbar instr...»6 similar in design and results with that of the MRC trial)

  • Limited evidence (level C) that in selected patients with severe CLBP and degenerative changes at L4-L5 or L5-S1 level, who have failed to improve with conservative treatment, surgery is successful in relation to improvements in functional disability (Oswestry) and pain up to 2 years after treatment when compared to traditional non-specific conservative treatment in Sweden.
  • Moderate evidence (level B) that surgery is similar to a combined program of cognitive intervention and exercises provided in Norway or UK in improving functional disability (Oswestry).
  • Strong evidence (level A) that demanding, expensive and higher risk surgical techniques are not better than the most straightforward and least expensive surgical technique of posterolateral fusion without internal fixation.

Kustannusvaikuttavuus:

  • Conflicting evidence (level C) on the cost-effectiveness of surgery: it appeared to be slightly more cost-effective than (or equal to) traditional non-specific conservative treatment in Sweden, but twice as expensive as a combined program of cognitive intervention and exercises provided in UK, for which similar clinical results had been obtained.

Suositukset:

European Guidelines Group «Airaksinen O, Brox JL, Cedraschi C ym. COST B13 Wo...»7 does not recommend surgery for CLBP unless 2 years of all other recommended conservative treatments have failed and combined programs of cognitive intervention and exercises are not available in the given geographical area. Considering the high complication rates of surgery, as well as the costs to society and suffering for patients with failed back surgery, we strongly recommend that only carefully selected patients with severe pain should be considered for this procedure.

Kirjallisuutta

  1. Fritzell P, Hägg O, Wessberg P ym. 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;26:2521-32; discussion 2532-4 «PMID: 11725230»PubMed
  2. Fritzell P, Hägg O, Wessberg P ym. 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;27:1131-41 «PMID: 12045508»PubMed
  3. Fritzell P, Hägg O, Wessberg P ym. 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;26:2521-32; discussion 2532-4 «PMID: 11725230»PubMed
  4. Fritzell P, Hägg O, Jonsson D ym. 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;29:421-34; discussion Z3 «PMID: 15094539»PubMed
  5. Fairbank J, Frost H, Wilson-MacDonald J ym. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ 2005;330:1233 «PMID: 15911537»PubMed
  6. Brox JI. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises for the postlaminectomy syndrome. Ann Rheum Dis 2003; (Suppl. 1):229
  7. Airaksinen O, Brox JL, Cedraschi C ym. COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006;15(Suppl.2):S192-300