jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Nov. 02, 2020

June. 30, 2024

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)

Effect of Treatment Device for proprioceptive function in the elderly patients with chronic low back pain (DTPA trial)

Aug. 26, 2022

32

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.

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.

None

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.

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.

June. 30, 2024

Yes

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

https://jrct.mhlw.go.jp/latest-detail/jRCTs042200058

Yoshihito Sakai

National Center for Geriatrics and Gerontology

7-430, Morioka-cho, Obu city, Aich Pref.

+81-562-46-2311

jsakai@ncgg.go.jp

Yoshihito Sakai

National Center for Geriatrics and Gerontology

7-430, Morioka-cho, Obu city, Aich Pref.

+81-562-46-2311

jsakai@ncgg.go.jp

Complete

April. 01, 2021

April. 02, 2021
30

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Low back pain lasting for more than 6 months.
2. Pain intensity visual analogue scale (VAS) more than 3.
3. No specific fidings for low bacl pain on ragiogram or MRI of the lumbar spine.
4. In proprioceptive function diagnosis, a decrease in proprioceptive function based on Z score <-1.0 is observed.

















































1. Past history of vertebral fractrure within 1 year.
2. Persons who need asistence for standing.
3. Patients who has central nerve disease such as cerebral infarction, cerebral hemorrhage, brain or soinal tunorsa and cervical or thocacic myeloptahy.
4. Myogenic disease such as muscular dystrophy.

65age old over
No limit

Both

Chronic low back pain

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.

Chronic low back pain

Proprioception Low back pain Elderly people

D017116

D014732

Intensity of low back pain

Improvement in proprioceptive function
Disability caused by low back pain

Fujita Health University Certified Clinical Research Review Board
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Japan, Aichi

+81-562-93-2865

crb-f@fujita-hu.ac.jp
Approval

Oct. 21, 2020

none

History of Changes

No Publication date
3 June. 30, 2024 (this page) Changes
2 July. 19, 2021 Detail Changes
1 Nov. 02, 2020 Detail