Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy (HBOT-HPLT-DPN)

Hyperbaric Oxygen Therapy Versus High Power Laser Therapy On Sensorimotor Functions In Patients With Diabetic Peripheral Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathic Pain (DPN)
• Intervention / Treatment: Other: Conventional Physiotherapy Program; Device: Hyperbaric Oxygen Therapy; Device: High-Intensity Laser Therapy

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.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11771
      • Kobri El Koba Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Physiotherapy; Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks).	Other: Conventional Physiotherapy Program; Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks)
Experimental: Hyperbaric Oxygen Therapy (HBOT); Conventional physiotherapy program plus HBOT sessions (100% oxygen at 2.5 ATA for 60 minutes, with 15 minutes gradual compression and 15 minutes decompression, totaling 90 minutes per session). 15 sessions over 3 weeks.	Device: Hyperbaric Oxygen Therapy; 100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.; Other Names: HPOT
Experimental: High-Power Laser Therapy (HPLT); Conventional physiotherapy program plus HPLT (MLS laser, M6). 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.	Device: High-Intensity Laser Therapy; 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.; Other Names: HPLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Michigan Neuropathy Screening Instrument (MNSI) score	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.	Baseline and 3 weeks post-treatment
Change in right sural nerve distal sensory latency	Right sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms).	Baseline and after 3 weeks of treatment
Change in left sural nerve distal sensory latency	Left sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms).	Baseline and after 3 weeks of treatment
Change in right sural nerve sensory amplitude	Right sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV).	Baseline and after 3 weeks of treatment
Change in left sural nerve sensory amplitude	Left sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV).	Baseline and after 3 weeks of treatment
Change in right sural nerve conduction velocity	Right sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).	Baseline and after 3 weeks of treatment
Change in left sural nerve conduction velocity	Left sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).	Baseline and after 3 weeks of treatment
Change in right peroneal nerve distal motor latency	Right peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms).	Baseline and after 3 weeks of treatment
Change in left peroneal nerve distal motor latency	Left peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms).	Baseline and after 3 weeks of treatment
Change in right peroneal nerve motor amplitude	Right peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV).	Baseline and after 3 weeks of treatment
Change in left peroneal nerve motor amplitude	Left peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV).	Baseline and after 3 weeks of treatment
Change in right peroneal nerve motor conduction velocity	Right peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).	Baseline and after 3 weeks of treatment
Change in left peroneal nerve motor conduction velocit	Left peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).	Baseline and after 3 weeks of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): July 6, 2025
• Study Completion (Actual): July 6, 2025

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: September 25, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 25, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Nerve Conduction Studies; Hyperbaric Oxygen Therapy; High Power Laser Therapy; Sensorimotor Functions; Michigan Neuropathy Screening Questionnaire
• Additional Relevant MeSH Terms: Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: P.T.REC/012/005181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be shared outside the research team to maintain patient privacy and data confidentiality in accordance with institutional guidelines.

Drug and device information, study documents

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