Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05622630 |
| Other study ID # |
ParacelsusHCBS 51/15 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 13, 2019 |
| Est. completion date |
March 16, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Paracelsus Harz Clinic Bad Suderode. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sensorimotor diabetic polyneuropathy is a common and serious complication of longstanding
diabetes mellitus. The therapeutic options are limited (pain therapy, antidepressants,
physical measures using direct current such as two- / four-cell baths). In the present study,
for the first time, after positive data from a pilot study, it is to be checked whether the
effectiveness of an existing therapy can be extended by treatment with heated granulate
stones in the rehabilitation setting.
Description:
The central aspect of this study is the proof of the effectiveness of the therapeutic
treatment of diabetic polyneuropathy with heated granulate stones.
Subsequent information from the study doctor and the patient's written consent will remove
the sociodemographic relationships from the standards of the Paracelsus Harz Clinic Bad
Suderode. Behavioral behavior and sporting behavior among those affected, as well as the
course of the disease, are treated using a questionnaire. Furthermore, medical parameters
(echocardiographic parameters, penalties, weight, BMI, waist-hip ratio, blood glucose, HbA1c,
total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, etc.) are determined.
A randomization list was created for randomization, with the randomization algorithm
assigning patient IDs to the two treatment groups. Randomization takes place using previously
sealed, opaque and consecutively numbered envelopes.
After randomization at time T0 (before the first treatment) and T1 (after the last
treatment), the patients receive a questionnaire (see appendix) in which they should state
the symptoms, how long they have existed and the assessment of the intensity. The assessment
of the intensity is based on a spectrum from 1 = minor complaints to 6 = severe complaints.
Quality of life is measured using the SF-12 questionnaire, and anxiety and depression using
the HADS questionnaire are also measured at time points T0 and T1.
Long-term ECGs are performed to determine the heart rate variability at the beginning and at
the end of the rehabilitation measure.
A vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the
metatarsophalangeal joint of the big toe, the inner ankle and the tibial tuberosity is also
carried out at time T0 and T1.
In the study group, the patients receive a foot bath treatment with heated stones of
different sizes three times a week for a period of 20 minutes. In the control group, therapy
with direct current (four-cell bath) is carried out. The study population consists of
patients from the Paracelsus Harz Clinic Bad Suderode who are undergoing rehabilitation due
to cardiovascular diseases and / or diabetes mellitus.
It is planned to start at time T0 with n = 34 rehabilitation patients in the basement and in
the KG. Even with a pessimistically estimated drop-out rate of 20% in the course of the study
at time T1 (after completion of the rehabilitation measure), n = 28 test persons per group
should still be available. This means that there are enough cases for stratifying analyzes.
With this case number planning, the criteria of a case number planning carried out are met.
Based on a planned power of the investigation of 80% (α = 0.05) with a drop-out of 20%, this
calculation resulted in a sample size of at least n = 28 subjects per group.
