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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Distal Symmetric Polyneuropathy
• Intervention / Treatment: Device: Four-Cell Galvanic Bath Therapy; Other: Conventional Rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Four-Cell Galvanic Bath Therapy; 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.; Other Names: Four-Cell Galvanic Bath; Galvanic Bath Therapy; Other: Conventional Rehabilitation; 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.
Active Comparator: 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.	Other: Conventional Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Stability (Stability Index) Measured by TecnoBody Prokin PK252	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	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)	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)	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	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)	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)	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)	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)

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2024
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Galvanic Bath Therapy Electrical Stimulation Neuropathic Pain Balance Postural Control Rehabilitation Physical Therapy Four-Cell Galvanic Bath
• Other Study ID Numbers: AEŞH-EK1-2025-057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No