Diabetic Peripheral Neuropathic Pain (DPN)
Conditions
Keywords
Hyperbaric Oxygen Therapy, High Power Laser Therapy, Sensorimotor Functions, Nerve Conduction Studies, Michigan Neuropathy Screening Questionnaire
Brief summary
The purpose of this study is to compare the clinical effects of Hyperbaric Oxygen Therapy (HBOT) versus High-Intensity Laser Therapy (HPLT) on sensorimotor functions and nerve conduction in patients suffering from painful diabetic peripheral neuropathy. Participants are divided into three equal groups. The first group receives a traditional physiotherapy program focused on ankle and foot exercises. The second group receives hyperbaric oxygen therapy sessions in addition to the traditional program. The third group receives high-power MLS laser therapy alongside the traditional program. Investigators look at whether either advanced intervention shows superiority in improving nerve functionality and reducing neuropathic pain.
Detailed description
Diabetic peripheral neuropathy (DPN) is a major microvascular complication of diabetes leading to progressive nerve damage and neuropathic pain. This randomized controlled trial evaluates and compares the efficacy of two non-pharmacological interventions: Hyperbaric Oxygen Therapy (HBOT) and High-Intensity Laser Therapy (HPLT). A total of 66 medically controlled patients with painful diabetic neuropathy are randomly assigned into three equal parallel groups (22 patients per group): * Control Group (A): Receives a traditional physiotherapy program including foot and ankle ROM exercises, strengthening, and functional walking training for 5 sessions per week for 3 weeks. * Study Group (B): Receives Hyperbaric Oxygen Therapy (100% oxygen at 2.5 ATA for 60 minutes, totaling 90 minutes per session) for 15 sessions over 3 weeks, combined with the traditional physiotherapy program. * Study Group (C): Receives High-Power Laser Therapy using a Multiwave Locked System (MLS) laser device (1500 Hz frequency) applied every other day for 9 sessions over 3 weeks, combined with the traditional physiotherapy program. Assessments are conducted before and after the 3-week treatment period using objective Nerve Conduction Studies (NCS) for the sural and common peroneal nerves, and subjective screening via the Arabic Michigan Neuropathy Screening Instrument (MNSI) score.
Interventions
Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks)
DEVICEHyperbaric Oxygen Therapy
100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.
MLS laser (M6 device) at 1500 Hz frequency, applied every other day for 9 sessions over 3 weeks. Includes a remote foot scan followed by contact application on 7 specific lower extremity areas.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with type 2 diabetes mellitus for more than 5 years. * Presence of painful diabetic peripheral neuropathy lasting for more than 6 months. * Presence of sensory abnormalities, burning pain, and impaired nerve conduction velocity in the lower extremities. * Medically controlled glycemic status. * Sufficient cognitive abilities with a Mini-Mental State Examination (MMSE) score greater than 24. * Fit for hyperbaric pressure therapy with a cardiac ejection fraction (CEF) equal to or greater than 50% and blood pressure equal to or less than 150/90 mmHg.
Exclusion criteria
* Peripheral neuropathy resulting from causes other than diabetes (e.g., vitamin B12 deficiency, alcohol abuse, or trauma). * Severe vascular insufficiency in the lower limbs. * Uncontrolled medical conditions such as tumors or thyroid dysfunction. * Pregnancy. * Presence of metallic implantations or cardiac pacemakers. * Severe visual, auditory, or cognitive impairment (MMSE score less than 24). * Chronic obstructive pulmonary disease (COPD) or other contraindications to hyperbaric oxygen therapy. * History of other neurological diseases (e.g., stroke or multiple sclerosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Michigan Neuropathy Screening Instrument (MNSI) score | Baseline and 3 weeks post-treatment | The Michigan Neuropathy Screening Instrument (MNSI) questionnaire was used to assess symptoms of diabetic peripheral neuropathy. Abnormal responses were summed to obtain the total score. The questionnaire score ranges from 0 to 13, with higher scores indicating greater neuropathic symptom burden. |
| Change in right sural nerve distal sensory latency | Baseline and after 3 weeks of treatment | Right sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
| Change in left sural nerve distal sensory latency | Baseline and after 3 weeks of treatment | Left sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
| Change in right sural nerve sensory amplitude | Baseline and after 3 weeks of treatment | Right sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV). |
| Change in left sural nerve sensory amplitude | Baseline and after 3 weeks of treatment | Left sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV). |
| Change in right sural nerve conduction velocity | Baseline and after 3 weeks of treatment | Right sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
| Change in left sural nerve conduction velocity | Baseline and after 3 weeks of treatment | Left sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
| Change in right peroneal nerve distal motor latency | Baseline and after 3 weeks of treatment | Right peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
| Change in left peroneal nerve distal motor latency | Baseline and after 3 weeks of treatment | Left peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
| Change in right peroneal nerve motor amplitude | Baseline and after 3 weeks of treatment | Right peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV). |
| Change in left peroneal nerve motor amplitude | Baseline and after 3 weeks of treatment | Left peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV). |
| Change in right peroneal nerve motor conduction velocity | Baseline and after 3 weeks of treatment | Right peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
| Change in left peroneal nerve motor conduction velocit | Baseline and after 3 weeks of treatment | Left peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
Countries
Egypt
Outcome results
None listed