NCT01400282

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 22, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

July 21, 2011

Last Update Submit

July 21, 2011

Conditions

Lowback and Leg Pain

Outcome Measures

Primary Outcomes (1)

  • Patient's Global Impression of Change (PGIC)

Secondary Outcomes (2)

  • Intensity of Pain

  • Quality of Life (EQ-5D)

Study Arms (2)

Sequence 1

OTHER

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

Device: High frequency spinal cord stimulation

Sequence 2

OTHER

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

Device: High frequency spinal cord stimulation

Interventions

High frequency spinal cord stimulationDEVICE
Sequence 1Sequence 2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Morges, 1110, Switzerland

RECRUITING

Department of Anaesthesia, The James Cook University Hospital

Middlesbrough, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 34854473DERIVED

Central Study Contacts

Christophe Perruchoud, MD

CONTACT

+41218042868christophe.perruchoud@chuv.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 22, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

July 22, 2011

Record last verified: 2011-06

Locations

CH(1)GB(1)