NCT03858790

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

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

February 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

February 20, 2019

Last Update Submit

February 27, 2019

Conditions

PainChronic PainBack PainSpinal Cord StimulationNervous System Diseases

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • The difference of Visual-analogue scale (VAS) between the experimental group and the control group

    Pain will be evaluated in the different groups according to the Visual-analogue scale (VAS) varying from 0 to 10 with a higher score indicating a higher level of pain.

    13 weeks

Secondary Outcomes (5)

  • Changes in VAS

    4、12、24 weeks

  • Sleep Quality

    4、12、24 weeks

  • Changes in Beck Depression Inventory

    4、12、24 weeks

  • Change in quality of life as measured by SF-36

    4、12、24 weeks

  • Number of subjects with adverse events

    24 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

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

Device: PINS Spinal Cord Stimulator

Control

SHAM COMPARATOR

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

Device: PINS Spinal Cord Stimulator

Interventions

PINS Spinal Cord StimulatorDEVICE

Subjects will be implanted with PINS spinal cord stimulator

ControlExperimental

Eligibility Criteria

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

You may qualify if:

  • 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.
  • VAS ≥ 5
  • Be 18 years of age or older at the time of enrollment
  • Be willing and able to comply with study-related requirements, procedures, and visits
  • Be willing and capable of giving informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Related Publications (3)

  • 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

  • Lu Y, Xie D, Zhang X, Dong S, Zhang H, Yu B, Wang G, Wang JJ, Li L. Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System. Front Neurosci. 2020 Dec 8;14:594696. doi: 10.3389/fnins.2020.594696. eCollection 2020.

    PMID: 33363453DERIVED

  • Lu Y, Mao P, Wang G, Tao W, Xiong D, Ma K, Li R, Feng D, Duan W, Li S, Fu Z, Feng Z, Jin Y, Wan L, Lu Y, Zhang D, Fan B, Wang JJ, Li L. Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study). Trials. 2020 Oct 7;21(1):834. doi: 10.1186/s13063-020-04768-3.

    PMID: 33028415DERIVED

MeSH Terms

Conditions

PainChronic PainBack PainNervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fumin Jia, PhD

CONTACT

010-60736388pins_medical@163.con

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

March 1, 2019

Study Start

February 1, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

CN(1)