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Effects of Four-Cell Galvanic Therapy on Pain and Balance in Diabetic Peripheral Neuropathy (GABATH-DPN)

10 maja 2026 zaktualizowane przez: ALP KAAN SAFA YAŞAR, Ankara Etlik City Hospital

Effects of Four-Cell Galvanic Bath Therapy on Pain and Balance in Patients With Diabetic Distal Symmetric Polyneuropathy: A Prospective, Randomized, Controlled, Single-Blind Study

This study aims to evaluate the effects of four-cell galvanic bath therapy on pain and balance in patients with diabetic distal symmetric polyneuropathy. Diabetic peripheral neuropathy is a common complication of diabetes that can lead to pain, sensory loss, and impaired balance. In this randomized controlled study, participants received either conventional rehabilitation alone or conventional rehabilitation combined with four-cell galvanic bath therapy. The intervention was applied over a 4-week period. Pain and balance outcomes were assessed using standardized clinical measures. The findings of this study may help determine the effectiveness of galvanic bath therapy as a supportive treatment option in patients with diabetic neuropathy.

Przegląd badań

Szczegółowy opis

Diabetic distal symmetric polyneuropathy (DSPN) is one of the most prevalent chronic complications of diabetes mellitus and is characterized by progressive peripheral nerve damage, leading to symptoms such as distal sensory loss, neuropathic pain, and impaired proprioception. These alterations negatively affect postural control mechanisms, resulting in balance impairment, increased risk of falls, and reduced functional independence. As a consequence, DSPN significantly decreases quality of life and poses an important clinical and socioeconomic burden.

Conventional rehabilitation programs, including range of motion, strengthening, balance, coordination, and endurance exercises, are commonly used in the management of DSPN. However, despite these interventions, persistent neuropathic pain and balance deficits often remain inadequately controlled. Therefore, there is a growing interest in adjunctive therapeutic approaches that target both sensory and motor components of postural control.

Electrical stimulation modalities have been proposed as potential therapeutic options due to their ability to modulate peripheral nerve excitability and enhance somatosensory feedback. Four-cell galvanic bath therapy is a non-invasive intervention that applies low-intensity direct current through water-filled electrodes to the upper and lower extremities. This method may stimulate cutaneous receptors and peripheral nerve endings, increase afferent sensory input, and facilitate neuromuscular activation. Through these mechanisms, galvanic bath therapy may contribute to improved postural stability and reduction of neuropathic pain. However, current evidence regarding its combined effects on both pain and balance in patients with DSPN is limited, highlighting the need for well-designed clinical trials.

This study was designed as a prospective, randomized, controlled, single-blind clinical trial including patients aged 40-75 years diagnosed with DSPN. Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving four-cell galvanic bath therapy in addition to conventional rehabilitation or a control group receiving only conventional rehabilitation. The rehabilitation program consisted of standardized exercises including range of motion, stretching, strengthening, balance, coordination, and endurance training, and was applied for 4 weeks, three sessions per week, with each session lasting approximately one hour.

In the intervention group, four-cell galvanic bath therapy was administered concurrently with the conventional rehabilitation program. The application was performed using a standardized protocol to ensure consistency across participants. Outcome measures were assessed at baseline and after the intervention period using validated clinical assessment tools. Pain intensity and balance performance were evaluated as primary outcomes, while additional functional and quality of life parameters were assessed as secondary outcomes.

The primary objective of this study is to investigate the effectiveness of four-cell galvanic bath therapy on reducing pain and improving balance in patients with DSPN. A secondary objective is to explore whether enhanced somatosensory input through electrical stimulation contributes to improved postural control and functional outcomes. The findings of this study are expected to provide clinically relevant evidence regarding the role of galvanic bath therapy as an adjunctive treatment modality in the rehabilitation of patients with diabetic peripheral neuropathy.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

66

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Ankara, Turcja (Türkiye)
        • Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Diagnosis of type 2 diabetes mellitus
  2. Confirmed diagnosis of diabetic distal symmetric polyneuropathy according to the 2009 Toronto Consensus criteria
  3. Age between 40 and 75 years
  4. Adequate cognitive function to understand and respond to questionnaires and follow instructions (Mini-Mental State Examination score ≥ 24)
  5. No initiation or dosage change in neuropathic pain medication within the last 1 month
  6. Sufficient functional mobility to participate in the assessment and treatment protocol (ability to stand independently or with minimal assistance)

Exclusion Criteria:

  1. Presence of lower extremity amputation
  2. Active diabetic foot ulcer, significant skin integrity impairment, or open wound in the treatment area
  3. Cognitive impairment (MMSE < 24) or communication problems interfering with assessments
  4. Presence of orthopedic, musculoskeletal, or peripheral conditions affecting balance
  5. Medical instability
  6. Use of medications affecting balance or cognitive function
  7. Use of assistive devices
  8. Severe musculoskeletal disorders
  9. Initiation or dosage change of neuropathic pain medication within the last 1 month
  10. Presence of Charcot neuroarthropathy
  11. Polyneuropathy due to causes other than diabetes

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation
Participants received four-cell galvanic bath therapy in addition to a conventional rehabilitation program. The rehabilitation program included range of motion, stretching, strengthening, balance, coordination, and endurance exercises. The intervention was applied for 4 weeks, three sessions per week, with each session lasting approximately one hour.
Four-cell galvanic bath therapy was applied using a direct current (1.5 mA) delivered through water-filled electrodes to both upper and lower extremities for 20 minutes per session, three times per week for 4 weeks.
Inne nazwy:
  • Four-Cell Galvanic Bath
  • Galvanic Bath Therapy
A standardized rehabilitation program including range of motion, stretching, strengthening, balance, coordination, and endurance exercises, performed 3 times per week for 4 weeks, with each session lasting approximately 60 minutes.
Aktywny komparator: Conventional Rehabilitation Alone
Participants received a conventional rehabilitation program consisting of range of motion, stretching, strengthening, balance, coordination, and endurance exercises. The program was applied for 4 weeks, three sessions per week, with each session lasting approximately one hour.
A standardized rehabilitation program including range of motion, stretching, strengthening, balance, coordination, and endurance exercises, performed 3 times per week for 4 weeks, with each session lasting approximately 60 minutes.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Postural Stability (Stability Index) Measured by TecnoBody Prokin PK252
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Postural stability will be assessed using the TecnoBody Prokin PK252 device. The Stability Index parameter reflects postural sway based on center of pressure displacement. Higher values indicate poorer balance performance and reduced postural stability.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Berg Balance Scale (BBS)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Balance performance will be assessed using the Berg Balance Scale (BBS). The BBS is a 14-item clinical balance assessment scale with a total score ranging from 0 to 56. Higher scores indicate better balance performance and lower fall risk. Assessments will be performed at baseline, post-treatment, and follow-up, and scores will be compared between groups.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Functional Reach Test (FRT)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Dynamic balance will be assessed using the Functional Reach Test (FRT). The maximal forward reach distance will be measured in centimeters while maintaining a fixed standing position without stepping. Greater reach distance indicates better dynamic balance and postural control, whereas shorter reach distance indicates impaired balance performance and increased fall risk. Assessments will be performed at baseline, post-treatment, and follow-up.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Timed Up and Go Test (TUG)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants will stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. Completion time will be recorded in seconds. Shorter completion time indicates better functional mobility and balance performance, whereas longer completion time indicates impaired mobility and balance. Assessments will be performed at baseline, post-treatment, and follow-up.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Single Leg Stance Test
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Static balance will be assessed using the Single Leg Stance Test. Participants will be instructed to stand on one leg without external support for as long as possible. Standing duration will be recorded in seconds. Longer standing duration indicates better static balance and postural stability, whereas shorter duration indicates impaired balance performance. Assessments will be performed at baseline, post-treatment, and follow-up.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Pain severity will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). Higher total scores indicate greater pain severity. Assessments will be performed at baseline, post-treatment, and follow-up.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Physical Component Summary of SF-12 (PCS-12)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Physical health status will be assessed using the Physical Component Summary (PCS-12) score of the Short Form-12 Health Survey. Scores range from 0 to 100, with higher scores indicating better physical health status.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Mental Component Summary of SF-12 (MCS-12)
Ramy czasowe: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Mental health status will be assessed using the Mental Component Summary (MCS-12) score of the Short Form-12 Health Survey. Scores range from 0 to 100, with higher scores indicating better mental health status.
Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 grudnia 2024

Zakończenie podstawowe (Rzeczywisty)

10 marca 2026

Ukończenie studiów (Rzeczywisty)

10 marca 2026

Daty rejestracji na studia

Pierwszy przesłany

28 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 maja 2026

Ostatnia weryfikacja

1 marca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared due to privacy concerns and institutional data protection policies.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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