Effects of Four-Cell Galvanic Therapy on Pain and Balance in Diabetic Peripheral Neuropathy

NCT07590011 | Completed

• 1 other identifier: AEŞH-EK1-2025-057
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Distal Symmetric Polyneuropathy

Keywords

Galvanic Bath Therapy Electrical Stimulation Neuropathic Pain Balance Postural Control Rehabilitation Physical Therapy Four-Cell Galvanic Bath

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Berg Balance Scale (BBS)

  Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

• Functional Reach Test (FRT)

  Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

• Timed Up and Go Test (TUG)

  Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

• Single Leg Stance Test

  Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

• Short-Form McGill Pain Questionnaire (SF-MPQ)

  Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)

Study Arms (2)

Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation

EXPERIMENTAL

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; Other: Conventional Rehabilitation

Conventional Rehabilitation Alone

ACTIVE COMPARATOR

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

Interventions

Four-Cell Galvanic Bath Therapy DEVICE

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.

Also known as: Four-Cell Galvanic Bath, Galvanic Bath Therapy

Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation

Conventional Rehabilitation OTHER

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.

Conventional Rehabilitation Alone; Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to group allocation to minimize assessment bias. Participants and care providers were not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident, MD

Model Details: 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 conventional rehabilitation alone. Each participant remained in their assigned group throughout the study period.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: May 15, 2026
• Study Start: December 24, 2024
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)