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

Spinal Cord Stimulation System in the Treatment of Chronic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Nervous System Diseases; Pain; Back Pain; Chronic Pain; Spinal Cord Stimulation
• Intervention / Treatment: Device: PINS Spinal Cord Stimulator

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Bifa Fan; Phone Number: 010-84205959; Email: fbf1616@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Subjects' PINS spinal cord stimulator randomized to this arm is on always	Device: PINS Spinal Cord Stimulator; Subjects will be implanted with PINS spinal cord stimulator
SHAM_COMPARATOR: Control; Subjects' PINS spinal cord stimulator randomized to this arm is off for a week	Device: PINS Spinal Cord Stimulator; Subjects will be implanted with PINS spinal cord stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in VAS	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.	4、12、24 weeks
Sleep Quality	Quality of sleep will be assessed according to the number of nights with awakenings.	4、12、24 weeks
Changes in Beck Depression Inventory	This will be assessed using the Beck Depression Inventory, a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression. Higher values represent greater severity of depression.	4、12、24 weeks
Change in quality of life as measured by SF-36	The quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) questionnaire.	4、12、24 weeks
Number of subjects with adverse events	The number of adverse events will be record at each visit.	24 weeks

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Nervous System Diseases
• Other Study ID Numbers: PINS-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No