PainNCT03858790
Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain
A study testing PINS Spinal Cord Stimulator in people with Pain and Chronic Pain, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Back Pain
- What is being tested?
- PINS Spinal Cord Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Feb 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Bifa Fan, 010-84205959, fbf1616@yeah.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Chronic Pain, Back Pain, Spinal Cord Stimulation, Nervous System Diseases
- Being tested
- PINS Spinal Cord Stimulator
- Keywords
- Pain
- Medical subject headings
- Pain, Chronic Pain, Back Pain, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINS Spinal Cord StimulatorDevice
Subjects will be implanted with PINS spinal cord stimulator
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects' PINS spinal cord stimulator randomized to this arm is on always Receives: Device: PINS Spinal Cord Stimulator |
| Control | Sham comparator | Subjects' PINS spinal cord stimulator randomized to this arm is off for a week Receives: Device: PINS Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 weeks
Secondary outcomes (5)
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.
Measured: 4、12、24 weeks
Sleep Quality
Quality of sleep will be assessed according to the number of nights with awakenings.
Measured: 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.
Measured: 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.
Measured: 4、12、24 weeks
Number of subjects with adverse events
The number of adverse events will be record at each visit.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study startFeb 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858790
- Sponsor's protocol ID
- PINS-030
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34854473Lu 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.
PubMed 33363453Lu 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.
PubMed 33028415
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation System in the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT03858790
- Acronym / sponsor ID
- PINS-030
- Conditions
- Pain, Chronic Pain, Back Pain, Spinal Cord Stimulation, Nervous System Diseases
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: PINS Spinal Cord StimulatorSubjects' PINS spinal cord stimulator randomized to this arm is on always |
| Control | Sham comparator | Device: PINS Spinal Cord StimulatorSubjects' PINS spinal cord stimulator randomized to this arm is off for a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PINS Spinal Cord StimulatorSubjects will be implanted with PINS spinal cord stimulator | Device | Control, Experimental |
Primary outcome
The difference of Visual-analogue scale (VAS) between the experimental group and the control group
Time frame: 13 weeks
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.
5 secondary outcomes
Changes in VAS
Time frame: 4、12、24 weeks
Sleep Quality
Time frame: 4、12、24 weeks
Changes in Beck Depression Inventory
Time frame: 4、12、24 weeks
Change in quality of life as measured by SF-36
Time frame: 4、12、24 weeks
Number of subjects with adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 34854473O'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.
- Derived from this study: PubMed 33363453Lu 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.
- Derived from this study: PubMed 33028415Lu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PINS Spinal Cord Stimulator in people with Pain and Chronic Pain, run by Beijing Pins Medical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fumin Jia, PhD (010-60736388, pins_medical@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of Visual-analogue scale (VAS) between the experimental group and the control group (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858790, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.