Diabetic PolyneuropathyNCT05622630
Study of Physical Therapy in Patients With Diabetic Polyneuropathy
A study testing Four-cell bath and Gravel bath in people with Diabetic Polyneuropathy, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Four-cell bath and Gravel bath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2019to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years of age
- diabetic polyneuropathy
- Inpatient stay in the Paracelsus Harz Clinic Bad Suderode
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy
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.
Read the 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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Four-cell bath, Gravel bath
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-cell bathProcedure or surgery
Four-cell bath:Treatment with direct current
Gravel bathProcedure or surgery
Gravel bath:In this procedure, the patients are given a footbath with heated stones (granules) of different sizes for a period of 20 minutes, during which the patients are encouraged to move their feet (and, if applicable, hands) evenly.
| Study group | Role | What they receive |
|---|---|---|
| Four-cell bathroom | Active comparator | Four-cell bath:Treatment with direct current Receives: Procedure: Four-cell bath |
| Gravel bath | Active comparator | Gravel bath:In this procedure, the patients are given a footbath with heated stones (granules) of different sizes for a period of 20 minutes, during which the patients are encouraged to move their feet (and, if applicable, hands) evenly. Receives: Procedure: Gravel bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration sensation test
Vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the wrist, metatarsophalangeal joint of the big toe, inner ankle and the tibial tuberosity
Measured: baseline
Vibration sensation test
Vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the wrist, metatarsophalangeal joint of the big toe, inner ankle and the tibial
Measured: day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start13 Aug 2019
- Primary completion24 Aug 2021
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622630
- Sponsor's protocol ID
- ParacelsusHCBS 51/15
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2020
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strobel A, Laputsina V, Heinze V, Schulz S, Wienke A, Reer M, Schlitt A. Nonpharmaceutical treatment of distal sensorimotor polyneuropathy in diabetic patients: an unblinded randomized clinical trial. BMC Complement Med Ther. 2025 Mar 6;25(1):93. doi: 10.1186/s12906-025-04830-0.
PubMed 40050870
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT05622630
- Acronym / sponsor ID
- ParacelsusHCBS 51/15
- Conditions
- Diabetic Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.University, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four-cell bathroom | Active comparator | Procedure: Four-cell bathFour-cell bath:Treatment with direct current |
| Gravel bath | Active comparator | Procedure: Gravel bathGravel bath:In this procedure, the patients are given a footbath with heated stones (granules) of different sizes for a period of 20 minutes, during which the patients are encouraged to move their feet (and, if applicable, hands) evenly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18 years of age
- diabetic polyneuropathy
- Inpatient stay in the Paracelsus Harz Clinic Bad Suderode
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four-cell bathFour-cell bath:Treatment with direct current | Procedure or surgery | Four-cell bathroom |
| Gravel bathGravel bath:In this procedure, the patients are given a footbath with heated stones (granules) of different sizes for a period of 20 minutes, during which the patients are encouraged to move their feet (and, if applicable, hands) evenly. | Procedure or surgery | Gravel bath |
Primary outcome
Vibration sensation test
Time frame: baseline
Vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the wrist, metatarsophalangeal joint of the big toe, inner ankle and the tibial tuberosity
Vibration sensation test
Time frame: day 20
Vibration sensation test with the tuning fork (8/8 scale) according to Rydel-Seiffer on the wrist, metatarsophalangeal joint of the big toe, inner ankle and the tibial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Derived from this study: PubMed 40050870Strobel A, Laputsina V, Heinze V, Schulz S, Wienke A, Reer M, Schlitt A. Nonpharmaceutical treatment of distal sensorimotor polyneuropathy in diabetic patients: an unblinded randomized clinical trial. BMC Complement Med Ther. 2025 Mar 6;25(1):93. doi: 10.1186/s12906-025-04830-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-cell bath and Gravel bath in people with Diabetic Polyneuropathy, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration sensation test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.