Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Subjects' PINS spinal cord stimulator randomized to this arm is on always |
|
| Control | Sham Comparator | Subjects' PINS spinal cord stimulator randomized to this arm is off for a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINS Spinal Cord Stimulator | Device | Subjects will be implanted with PINS spinal cord stimulator |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fumin Jia, PhD | Contact | 010-60736388 | pins_medical@163.con |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34854473 | Derived | 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. | |
| 33363453 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 33028415 | Derived | 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. |