Analgesic Efficacy of High Frequency Spinal Cord Stimulation

NCT ID: NCT01400282

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-09-30

Brief Summary

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The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.

Detailed Description

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Conditions

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Lowback and Leg Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sequence 1

Conventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks)

Group Type OTHER

High frequency spinal cord stimulation

Intervention Type DEVICE

Sequence 2

Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks)

Group Type OTHER

High frequency spinal cord stimulation

Intervention Type DEVICE

Interventions

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High frequency spinal cord stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* signed informed consent
* treated with spinal cord stimulation
* stable pain relief achieved

Exclusion Criteria

* failure to give informed consent
* unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ensemble Hospitalier de la Côte

OTHER

Sponsor Role lead

Responsible Party

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Ensemble Hospitalier de la Côte

Locations

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Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)

Morges, , Switzerland

Site Status RECRUITING

Department of Anaesthesia, The James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Switzerland United Kingdom

Central Contacts

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Christophe Perruchoud, MD

Role: CONTACT

+41218042868

Facility Contacts

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Christophe Perruchoud, MD

Role: primary

+41218042868

Sam Eldabe, MD

Role: primary

+44 164 228 24 17

References

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O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Reference Type DERIVED
PMID: 34854473 (View on PubMed)

Other Identifiers

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EHC-JCH

Identifier Type: -

Identifier Source: org_study_id

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