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

B

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)

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

Trial contacts and locations

1

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Central trial contact

Fumin Jia, PhD

Data sourced from clinicaltrials.gov

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