Diabetic Distal Symmetric PolyneuropathyGABATH-DPNNCT07590011
Effects of Four-Cell Galvanic Therapy on Pain and Balance in Diabetic Peripheral Neuropathy
A study testing Four-Cell Galvanic Bath Therapy and Conventional Rehabilitation in people with Diabetic Distal Symmetric Polyneuropathy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Distal Symmetric Polyneuropathy
- What is being tested?
- Four-Cell Galvanic Bath Therapy and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Distal Symmetric Polyneuropathy
- Being tested
- Four-Cell Galvanic Bath Therapy, Conventional Rehabilitation
- Keywords
- Galvanic Bath Therapy Electrical Stimulation Neuropathic Pain Balance Postural Control Rehabilitation Physical Therapy Four-Cell Galvanic Bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-Cell Galvanic Bath TherapyDevice
Also called Four-Cell Galvanic Bath, 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.
Conventional RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start24 Dec 2024
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Distal Symmetric PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ALP KAAN SAFA YAŞAR, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590011
- Sponsor's protocol ID
- AEŞH-EK1-2025-057
- Acronym
- GABATH-DPN
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07590011
- Acronym / sponsor ID
- GABATH-DPN / AEŞH-EK1-2025-057
- Conditions
- Diabetic Distal Symmetric Polyneuropathy
- Keywords
- Galvanic Bath Therapy Electrical Stimulation Neuropathic Pain Balance Postural Control Rehabilitation Physical Therapy Four-Cell Galvanic Bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation | Experimental | Device: Four-Cell Galvanic Bath Therapy, Other: Conventional RehabilitationParticipants 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. |
| Conventional Rehabilitation Alone | Active comparator | Other: Conventional RehabilitationParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four-Cell Galvanic Bath TherapyAlso: Four-Cell Galvanic Bath, Galvanic Bath TherapyFour-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. | Device | Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation |
| Conventional RehabilitationA 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. | Other | Conventional Rehabilitation Alone, Four-Cell Galvanic Bath Therapy + Conventional Rehabilitation |
Primary outcome
Postural Stability (Stability Index) Measured by TecnoBody Prokin PK252
Time frame: 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.
7 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Functional Reach Test (FRT)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Timed Up and Go Test (TUG)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Single Leg Stance Test
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Physical Component Summary of SF-12 (PCS-12)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Mental Component Summary of SF-12 (MCS-12)
Time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional data protection policies.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-Cell Galvanic Bath Therapy and Conventional Rehabilitation in people with Diabetic Distal Symmetric Polyneuropathy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability (Stability Index) Measured by TecnoBody Prokin PK252 (time frame: Baseline (Week 0), Post-treatment (Week 4), and Follow-up (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.