Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain

Beijing Pins Medical

Status: Unknown

Conditions: Back Pain; Chronic Pain; Nervous System Diseases; Spinal Cord Stimulation; Pain

Treatments: Device: PINS Spinal Cord Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03858790

PINS-030

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.

Full description

Adult patients with chronic intractable pain of the trunk and/or limbs who are candidates for a treatment with spinal cord stimulation will be prospectively randomized into 2 arms. Spinal cord stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months.
2. VAS ≥ 5
3. Be 18 years of age or older at the time of enrollment
4. Be willing and able to comply with study-related requirements, procedures, and visits
5. Be willing and capable of giving informed consent

Exclusion criteria

1. Pregnancy or potential for with unwillingness to use contraception
2. Have a current diagnosis of a coagulation disorder, bleeding diathesis
3. Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control
4. Have a life expectancy of less than 1 year
5. Have a condition currently requiring or likely to require the use of diathermy
6. Other inappropriate situations determined by the researcher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Experimental

Experimental group

Description:

Subjects' PINS spinal cord stimulator randomized to this arm is on always

Treatment:

Device: PINS Spinal Cord Stimulator

Control

Sham Comparator group

Description:

Subjects' PINS spinal cord stimulator randomized to this arm is off for a week

Treatment:

Device: PINS Spinal Cord Stimulator