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Nov. 02, 2020 |
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June. 30, 2024 |
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jRCTs042200058 |
Diagnosis and Treatment Device Based on Proprioceptive Approach for the Elderly Patients with Chronic Low Back Pain (DTPA for chronic low back pain for elderly patients) |
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Effect of Treatment Device for proprioceptive function in the elderly patients with chronic low back pain (DTPA trial) |
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Aug. 26, 2022 |
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32 |
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Patients 65 years of age or older with low back pain that has persisted for at least 6 months and has not improved after at least 1 month of drug therapy (including NSAIDs, weak opioids, and SNRIs) are eligible. Patients of any gender should have no vertebral fractures (including osteoporotic vertebral fractures, traumatic fractures, or pathological fractures) in the thoracolumbar spine. After performing a diagnosis of proprioceptive function in these study participants, those with proprioceptive dysfunction based on a Z score < -1.0 were eligible for treatment. |
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After obtaining study consent and performing a proprioceptive function diagnosis in 56 patients, 32 patients were eligible for treatment. All patients underwent 2 weeks of home treatment with the proprioception therapy device and were evaluated for low back pain and proprioceptive function at 2 weeks after completion of treatment. No patients dropped out of the study, and all 32 treated patients were evaluable. |
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None |
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In the evaluation of back pain and ADL after 2 weeks of treatment and 2 weeks after the end of treatment, 25 of 32 patients (78.1%) had a VAS that improved to 3 or less after treatment, of which 11 patients (45.8%) had a VAS that improved from less than 3 to 3 or worse after the end of treatment. The VAS after 2 weeks of treatment showed significant improvement compared to that before treatment (p<0.0001), and the VAS at 2.6 at the end of treatment worsened to 3.61 at 2 weeks of treatment, but there was no significant difference. (p=0.0162) The RDQ, EQ5D, and CSI showed significant improvement after 2 weeks of treatment, and no endpoints were significantly different between the end of treatment and 2 weeks after the end of treatment. The results of the pre- and post-treatment centripetal sway test and RMS value, an evaluation of intrinsic sensory function, showed that the mean RMS value of the treated area significantly improved from 0.774 before treatment to 1.709 2 weeks after treatment (p<0.001), and decreased to 1.567 2 weeks after treatment, but there was no significant difference compared to the end of treatment. The difference between the end of treatment and the beginning of treatment was not significant (p=0.999). (p=0.901) Of the 32 patients, 26 (81.3%) showed improvement in RMS values above the cutoff values for functional decline in each frequency band after 2 weeks of home treatment, and 19 (73.1%) of them improved their back pain VAS to 3 or less. |
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Older patients with chronic low back pain who had impaired proprioceptive function were diagnosed with proprioceptive function and given frequency vibration stimulation that specifically responded to their impaired propriocetive receptors for two weeks, and improvement in proprioceptive function was observed along with improvement in low back pain and associated ADL. This treatment was shown to be effective for chronic pain patients with impaired proprioceptive function. |
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June. 30, 2024 |
Yes |
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The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs042200058 |
Yoshihito Sakai |
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National Center for Geriatrics and Gerontology |
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7-430, Morioka-cho, Obu city, Aich Pref. |
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+81-562-46-2311 |
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jsakai@ncgg.go.jp |
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Yoshihito Sakai |
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National Center for Geriatrics and Gerontology |
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7-430, Morioka-cho, Obu city, Aich Pref. |
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+81-562-46-2311 |
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jsakai@ncgg.go.jp |
Complete |
April. 01, 2021 |
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| April. 02, 2021 | ||
| 30 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1. Low back pain lasting for more than 6 months. |
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1. Past history of vertebral fractrure within 1 year. |
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| 65age old over | ||
| No limit | ||
Both |
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Chronic low back pain |
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This device is used to perform proprioceptive function diagnosis for elderly people with chronic low back pain and to identify proprioceptor receptors with impaired function. A frequency-matched vibrational stimulus that responds to a dysfunctional receptor is applied once a minute for 3 minutes a day for 2 weeks to evaluate improvement in proprioceptive function and low back pain. |
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Chronic low back pain |
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Proprioception Low back pain Elderly people |
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D017116 |
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D014732 |
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Intensity of low back pain |
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Improvement in proprioceptive function |
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| Fujita Health University Certified Clinical Research Review Board | |
| 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Japan, Aichi | |
+81-562-93-2865 |
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| crb-f@fujita-hu.ac.jp | |
| Approval | |
Oct. 21, 2020 |
none |