Trial reportBMC complementary medicine and therapies2025
Nonpharmaceutical treatment of distal sensorimotor polyneuropathy in diabetic patients: an unblinded randomized clinical trial.
Trial report in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05622630 (Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Prospective Randomized Study of Physical Therapy in Patients With Diabetic Polyneuropathy
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundFor Diabetic polyneuropathy, the most prevalent form of polyneuropathy, there is a lack of evidence-based treatment options. Current approaches include pain management, alpha-lipoic acid, and antidepressants. Physical interventions, such as electrical stimulation (four-chamber galvanic bath) have been suggested but have limited supporting evidence. Heated granular stone therapy is another option to consider.
methodsAn unblinded randomized controlled trials was conducted in 68 diabetic patients with distal sensorimotor polyneuropathy undergoing rehabilitation for diabetes mellitus as a primary or secondary diagnosis in the Paracelsus-Harz-Clinic (Quedlinburg, Germany). Patients were randomized into either the intervention group receiving heated granulated stone footbaths, or the control group receiving four-chamber galvanic baths. The primary endpoint was the assessment of any change in polyneuropathy using a vibration sensation test (Rydel-Seiffer scale, 8/8) from admission to discharge, analyzed by t-test and multivariable regression. Additionally, serum TNF-α and IL-6 as potential markers for polyneuropathy were compared over time using paired t-test.
resultsThe mean age of the patients was 66.8 ± 7.8 years; 63.2% were male and mean BMI was 32.2 ± 6.4 kg/m
conclusionDiabetic patients with distal sensorimotor polyneuropathy benefit from physical treatment with administration of electrical stimulation (four-chamber galvanic bath) or a therapy with heated granulated stones three times a week. Our results indicate that heated stone therapy may be a potential treatment option. However, further research is required to understand the underlying biological processes.
trial registrationThe study was registered in clinical trials.gov (identifier: NCT05622630, registration date: 18/11/2022).
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