Intervention Review

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Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

  1. Dirk T Ubbink1,*,
  2. Hester Vermeulen2

Editorial Group: Cochrane Peripheral Vascular Diseases Group

Published Online: 28 FEB 2013

Assessed as up-to-date: 17 JAN 2013

DOI: 10.1002/14651858.CD004001.pub3

How to Cite

Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD004001. DOI: 10.1002/14651858.CD004001.pub3.

Author Information

  1. 1

    Academic Medical Centre, University of Amsterdam, Quality Assurance & Process Innovation, and Department of Surgery, Amsterdam, Netherlands

  2. 2

    Academic Medical Centre, University of Amsterdam & Amsterdam School of Health Professions, Department of Quality Assurance & Process Innovation, Amsterdam, Noord-Holland, Netherlands

*Dirk T Ubbink, Quality Assurance & Process Innovation, and Department of Surgery, Academic Medical Centre, University of Amsterdam, J1b-215 Academic Medical Centre, Meibergdreef 9, PO Box 22700, Amsterdam, 1100 DE, Netherlands. d.ubbink@amc.uva.nl.

Publication History

  1. Publication Status: Stable (no update expected for reasons given in 'What's new')
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by study ID]
Amann 2003

MethodsControlled clinical trial.


ParticipantsCountry: 17 European centres.
Number of participants: 112.
Age: SCS group = 68 ± 13 SD;
Control group = 67 ± 9 SD.
Sex: M=75; F=37.
Inclusion criteria: Non-reconstructable CLI. Fontaine stages III; persistent pain at rest > 2 weeks or ischaemic skin lesions.
Exclusion criteria: Extensive necrosis; infected gangrene; terminally ill.


InterventionsTreatment group: SCS + best medical therapy (n=73).
Control group: Best medical therapy (n=39).
Duration: 18 months follow up.


OutcomesLimb survival, pain relief, QoL, Fontaine stage, complications.


NotesTcpO2 selection.
Test stimulation.
Raw data available.


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)High riskD - Not used

Claeys 1996

MethodsRandomised controlled trial.


ParticipantsCountry: Germany.
Number of participants: 86.
Age: SCS group = 67.7 ± 11.9 SD;
Control group = 69.9 ± 10.2 SD.
Sex: M=49; F=37.
Inclusion criteria: Non-reconstructable CLI; Fontaine stage IV; ulcers or gangrene present for minimum of 3 weeks; ankle pressure < 50mmHg.
Exclusion criteria: Mixed type of ulceration; local infection; patients suitable for reconstructive procedures.


InterventionsTreatment group: SCS + PGE1 (n=45).
Control group: Conservative medical therapy - PGE1 (n=41).
Duration: 1 year follow up.


OutcomesLimb survival, pain relief, ABPI,
Fontaine stage, ulcer healing, complications.


NotesTcpO2.
Test stimulation.


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskB - Unclear

ESES

MethodsRandomised controlled trial. Randomisation by random-numbers table, stratified by diabetes, ankle pressure, and hospital. Treatment allocation performed in an independent institute.


ParticipantsCountry: The Netherlands, 17 centres.
Number of participants: 120.
Age: SCS group = 73.1 ± 9.8 SD;
Control group = 721.1 ± 10.6 SD.
Sex: M=70; F=50.
Inclusion criteria: Non-reconstructable CLI, persistent pain at rest > 2 weeks or ischaemic skin lesions, ankle systolic pressure < 50mmHg.
Exclusion criteria: Extensive necrosis, infected gangrene, terminally ill.


InterventionsTreatment group: SCS + best medical therapy (n=60).
Control group: Best medical therapy (n=60).
Duration: 2 years.


OutcomesLimb survival, pain relief, Fontaine stage,
QoL, ABPI
complications.


NotesTcpO2 selection.
Raw data available in Ubbink 1999b reference.


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskA - Adequate

Jivegard 1995

MethodsRandomised controlled trial. Method of randomisation: unsure.


ParticipantsCountry: Sweden, 2 university hospitals.
Number of participants: 51.
Age: SCS group = 73 ± 12 SD;
Control group = 73 ± 12 SD.
Inclusion criteria: Severe chronic (> 2 weeks duration) lower limb ischaemia. non-reconstructable CLI.
Exclusion criteria: Rapidly progressing ischaemia, gangrene of more than one toe, extensive infection and/or non-healing ischaemic ulcerations.


InterventionsTreatment group: SCS + oral analgesics (n=25).
Control group: Oral analgesic (n=26).
Duration: 18 months follow up.


OutcomesLimb survival, pain relief, ABPI, toe pressure, complications.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskB - Unclear

Spincemaille 2000a

MethodsRandomised controlled trial (preliminary results).


ParticipantsCountry: The Netherlands.
Number of participants: 37.
Age: SCS group: 72; Control group: 70. Range: 56 to 87.
Sex: M=28; F=9.
Inclusion criteria: Non-reconstructable CLI; persistent pain at rest, or ischaemic skin lesions.
Exclusion criteria: infected gangrene, terminally ill, ulcer surface > 3 cm.


InterventionsTreatment group: SCS+ best medical therapy (n=19).
Control group: Best medical therapy: analgesic and vasoactive drugs (n=18).
Duration: 2 years.


OutcomesLimb survival, pain relief.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Low riskA - Adequate

Suy 1994

MethodsRandomised controlled trial.


ParticipantsCountry: Belgium, 3 university hospitals.
Number of participants: 38.
Age: SCS group 66 ± 11 SD;
Control group 65 ± 9 SD.
Inclusion criteria: chronic ischaemic pain related to PAOD; non-reconstructable CLI (n=27) and Buerger (n=11 excluded).


InterventionsTreatment group: SCS (n=20).
Control group: Conservative therapy (n=18).
Duration: follow up 20 ± 15 months.


OutcomesLimb survival, pain relief,
Fontaine stage, complications.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Allocation concealment (selection bias)Unclear riskB - Unclear

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Claeys 1997aDouble publication.

Claeys 1997bNo controls.

Claeys 1998bDouble publication.

Claeys 1999Double publication.

Guarnera 1994Inclusion of reconstructable CLI patients.

Palombo 1995No controls.

Petrakis 2000No controls.

Tallis 1983No controls.

 
Comparison 1. Limb survival

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Amputations (12 months)6433Risk Difference (M-H, Fixed, 95% CI)-0.11 [-0.20, -0.02]

 2 Amputation rate in non-hypertensives (18 months)1Risk Difference (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Pain relief

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in VAS score (0-100; where 100 is worst) after 12 months2166Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Change in Pain Rating Index (overall; where higher is worse) after 12 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Change in VAS score (0-100; where 100 is worst) after 3 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 3. Clinical improvement

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Reaching Fontaine stage II2124Risk Difference (M-H, Fixed, 95% CI)0.33 [0.19, 0.47]

 2 Reaching Fontaine stage III2206Risk Difference (M-H, Random, 95% CI)0.07 [-0.24, 0.38]

 3 Ulcer healing and hypertension272Risk Difference (M-H, Fixed, 95% CI)-0.54 [-0.73, -0.35]

    3.1 Hypertensives
144Risk Difference (M-H, Fixed, 95% CI)-0.57 [-0.80, -0.33]

    3.2 Non-hypertensives
128Risk Difference (M-H, Fixed, 95% CI)-0.5 [-0.82, -0.18]

 
Comparison 4. Ankle/brachial index

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Ankle/brachial pressure index increase after 12 months2137Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 5. Quality of life

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Nottingham Health Profile (0-100; where 100 is worst) after 12 months1189Mean Difference (IV, Fixed, 95% CI)1.0 [-0.20, 2.20]

    1.1 Mobility score amputees
152Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Overall
185Mean Difference (IV, Fixed, 95% CI)1.0 [-0.20, 2.20]

    1.3 Mobility score non-amputees
152Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Euroqol (0-100; where 100 is worst) after 12 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 6. TcpO2

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 TcpO2 after 12 months2197Mean Difference (IV, Random, 95% CI)1.39 [-15.66, 18.44]

 
Comparison 7. Complications

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in stimulation requiring reintervention (within 12 months)6412Risk Difference (M-H, Random, 95% CI)0.12 [0.04, 0.20]

 2 Infection requiring removal6412Risk Difference (M-H, Fixed, 95% CI)0.03 [-0.00, 0.06]

 3 Battery: end of life6412Risk Difference (M-H, Fixed, 95% CI)0.04 [0.00, 0.07]

 4 Overall complications requiring re-intervention5375Risk Difference (M-H, Random, 95% CI)0.18 [0.03, 0.33]

 5 Initial implantation problems (not included in overall complications)2232Risk Difference (M-H, Random, 95% CI)0.08 [-0.06, 0.23]

 
Table 1. Costs

Costs (Euros)SCS (Euros)Conservative (Euros)

Hospitalisation11,77912,321

Rehabilitation67487471

Operative procedures8362417

Stimulator implant72150

Professional home careEqualEqual

Outpatient costsNegligibleNegligible

MedicationNegligibleNegligible

Non-medicalNegligibleNegligible

TOTAL36,50228,617