Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial
Abstract Background Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients’ quality of life seriously. Therefore, we developed this research protocol to evaluate the efficacy of repetitive functional magnetic stimulation (rFMS) in the...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07207-1 |
| _version_ | 1827982799429173248 |
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| author | Jiyang Li Jianxiong Wang Yue Hu Rui Jian Yulu Zhao Dan Li Tenggang Wan Wuga Jike Fangyuan Xu Maomao Huang |
| author_facet | Jiyang Li Jianxiong Wang Yue Hu Rui Jian Yulu Zhao Dan Li Tenggang Wan Wuga Jike Fangyuan Xu Maomao Huang |
| author_sort | Jiyang Li |
| collection | DOAJ |
| description | Abstract Background Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients’ quality of life seriously. Therefore, we developed this research protocol to evaluate the efficacy of repetitive functional magnetic stimulation (rFMS) in the sacral nerve in patients with neurogenic detrusor overactivity (NDO) after suprasacral spinal cord injury (SCI) and provide more options for rFMS in treating NDO after suprasacral SCI. Methods This study is a single-center, randomized, parallel-group clinical trial. We will recruit the patients with NDO after suprasacral SCI in the Rehabilitation Department of the Affiliated Hospital of Southwest Medical University from September 2022 to August 2023. They will be assigned to the rFMS group and the sham stimulation group randomly. The sample size is 66, with 33 patients in each group. The rFMS group will receive real rFMS treatment of the sacral nerve (100% stimulation intensity, 5 Hz, 20 min each time, five times a week), and the sham group will receive sham stimulation. Both groups will receive similar treatment strategies, including medication, standard urine management, acupuncture treatment, and health education. The bladder compliance (bladder capacity/detrusor pressure) and pudendal nerve electromyography will be evaluated at baseline, 8th week of treatment. The residual volume of the bladder and bladder diary will be recorded once a week during 8 weeks of treatments. SCI-QOL and NBSS will be evaluated at baseline, the 4th and 8th week of treatment. In addition, the above assessments will be followed up at 8 weeks after the end of treatment. Discussion It is expected that the bladder function, symptoms, and quality of life might be significantly improved after rFMS of the sacral nerve. Trial registration The China Clinical Trials Registry has approved this study, registration number: ChiCTR2100045148. Registered on April 7, 2021. |
| first_indexed | 2024-04-09T22:39:02Z |
| format | Article |
| id | doaj.art-23116994632147899e2eb468fa08caac |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:02Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-23116994632147899e2eb468fa08caac2023-03-22T12:17:31ZengBMCTrials1745-62152023-03-0124111210.1186/s13063-023-07207-1Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trialJiyang Li0Jianxiong Wang1Yue Hu2Rui Jian3Yulu Zhao4Dan Li5Tenggang Wan6Wuga Jike7Fangyuan Xu8Maomao Huang9Rehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityRehabilitation Medicine Department, The Affiliated Hospital of Southwest Medical UniversityAbstract Background Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients’ quality of life seriously. Therefore, we developed this research protocol to evaluate the efficacy of repetitive functional magnetic stimulation (rFMS) in the sacral nerve in patients with neurogenic detrusor overactivity (NDO) after suprasacral spinal cord injury (SCI) and provide more options for rFMS in treating NDO after suprasacral SCI. Methods This study is a single-center, randomized, parallel-group clinical trial. We will recruit the patients with NDO after suprasacral SCI in the Rehabilitation Department of the Affiliated Hospital of Southwest Medical University from September 2022 to August 2023. They will be assigned to the rFMS group and the sham stimulation group randomly. The sample size is 66, with 33 patients in each group. The rFMS group will receive real rFMS treatment of the sacral nerve (100% stimulation intensity, 5 Hz, 20 min each time, five times a week), and the sham group will receive sham stimulation. Both groups will receive similar treatment strategies, including medication, standard urine management, acupuncture treatment, and health education. The bladder compliance (bladder capacity/detrusor pressure) and pudendal nerve electromyography will be evaluated at baseline, 8th week of treatment. The residual volume of the bladder and bladder diary will be recorded once a week during 8 weeks of treatments. SCI-QOL and NBSS will be evaluated at baseline, the 4th and 8th week of treatment. In addition, the above assessments will be followed up at 8 weeks after the end of treatment. Discussion It is expected that the bladder function, symptoms, and quality of life might be significantly improved after rFMS of the sacral nerve. Trial registration The China Clinical Trials Registry has approved this study, registration number: ChiCTR2100045148. Registered on April 7, 2021.https://doi.org/10.1186/s13063-023-07207-1Neurogenic detrusor overactivityRepetitive functional magnetic stimulationSpinal cord injuryBladder functionPhysiotherapyRandomized controlled trial |
| spellingShingle | Jiyang Li Jianxiong Wang Yue Hu Rui Jian Yulu Zhao Dan Li Tenggang Wan Wuga Jike Fangyuan Xu Maomao Huang Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial Trials Neurogenic detrusor overactivity Repetitive functional magnetic stimulation Spinal cord injury Bladder function Physiotherapy Randomized controlled trial |
| title | Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial |
| title_full | Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial |
| title_fullStr | Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial |
| title_full_unstemmed | Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial |
| title_short | Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial |
| title_sort | effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury a study protocol for a randomized controlled trial |
| topic | Neurogenic detrusor overactivity Repetitive functional magnetic stimulation Spinal cord injury Bladder function Physiotherapy Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07207-1 |
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