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OpenTrials
Completed

NCT Number: NCT02988830

Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago

The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients over 18 years old
  • Having given their non-opposition
  • Affiliated to a national insurance scheme or beneficiary
  • Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments

Exclusion criteria

  • patients with lumbago that can be surgically handled or which justified a medullary stimulation
  • having been operated for the rachis for less than 6 months;
  • which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
  • for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
  • which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
  • MRI planned within the next year
  • pregnant or breast-feeding women.

Treatment and study plan

Subcutaneous Electric Lumbar Stimulation

Device

Primary outcomes

  1. Average pain per day on visual analogical scale

    Time frame: 12 months

Secondary outcomes

  1. Douleur neuropathique 4 (DN4) score

    Time frame: 12 months

    DN4 is a French neuropathic pain scale

  2. Average pain per day on visual analogical scale

    Time frame: 15 days

  3. OSWESTRY DISABILITY INDEX

    Time frame: 12 months

  4. 36-Item Short Form Health Survey score (SF 36)

    Time frame: 12 months

  5. DALLAS self-questionnaire

    Time frame: 12 months

  6. Tampa scale

    Time frame: 12 months

  7. Questionnaire Hospital Anxiety and Depression scale (HAD)

    Time frame: 12 months

  8. Pain Catastrophizing Scale (PCS)

    Time frame: 12 months

  9. Coping strategies questionnaire (CSQ)

    Time frame: 12 months

  10. Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: IMESCUT

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2016
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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