Analgesic Efficacy of High Frequency Spinal Cord Stimulation

Ensemble Hospitalier de la Côte

Status and phase: Unknown; Phase 4

Conditions: Lowback and Leg Pain

Treatments: Device: High frequency spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01400282

EHC-JCH

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Sequence 1

Other group

Description:

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

Treatment:

Device: High frequency spinal cord stimulation

Sequence 2

Other group

Description:

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

Treatment:

Device: High frequency spinal cord stimulation