Clinical trial NCT05622630: Study of Physical Therapy in Patients With Diabetic Polyneuropathy
Official title: Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Lead sponsor: Paracelsus Harz Clinic Bad Suderode.
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years of age
* diabetic polyneuropathy
* Inpatient stay in the Paracelsus Harz Clinic Bad Suderode

Exclusion Criteria:

* Lack of consent
* Infections on the extremities to be bathed
* Skin damage on the extremities to be bathed
* Pacemaker or ICD implantation
* Metal (e.g. osteosynthesis materials) in the parts of the body to be bathed

Primary outcomes:
measure: Vibration sensation test
timeFrame: baseline
measure: Vibration sensation test
timeFrame: day 20
Secondary outcomes:
Other outcomes:
Locations:
city: Quedlinburg
country: Germany
facility: Paracelsus-Harz-Clinic Bad Suderode
state: Saxonia
Study officials:
References: