Study of Physical Therapy in Patients With Diabetic Polyneuropathy

NCT05622630 | Completed

• 1 other identifier: ParacelsusHCBS 51/15
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  day 20

Study Arms (2)

Four-cell bathroom

ACTIVE COMPARATOR

Four-cell bath:Treatment with direct current

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.

Procedure: Gravel bath

Interventions

Four-cell bath PROCEDURE

Four-cell bath:Treatment with direct current

Four-cell bathroom

Gravel bath PROCEDURE

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.

Gravel bath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Harz Clinic Bad Suderode.: lead

Study Sites (1)

Paracelsus-Harz-Clinic Bad Suderode

Quedlinburg, Saxony, 06485, Germany

Location

Related Publications (1)

• 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.

  PMID: 40050870 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Baths

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 18, 2022
• Study Start: August 13, 2019
• Primary Completion: August 24, 2021
• Study Completion: March 16, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-09

Locations

DE (1)