Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy

NCT07848867 | Completed

• 1 other identifier: P.T.REC/012/005181
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN)

Keywords

Hyperbaric Oxygen Therapy; High Power Laser Therapy; Sensorimotor Functions; Nerve Conduction Studies; Michigan Neuropathy Screening Questionnaire

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (3)

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Hyperbaric Oxygen Therapy (HBOT)

EXPERIMENTAL

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

High-Power Laser Therapy (HPLT)

EXPERIMENTAL

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

Interventions

Conventional Physiotherapy Program OTHER

Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks)

Conventional Physiotherapy

Hyperbaric Oxygen Therapy DEVICE

100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.

Also known as: HPOT

Hyperbaric Oxygen Therapy (HBOT)

High-Intensity Laser Therapy DEVICE

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.

Also known as: HPLT

High-Power Laser Therapy (HPLT)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kobri El Koba Military Hospital

Cairo, Cairo Governorate, 11771, Egypt

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Physical Therapy

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 30, 2026
• Study Start: July 1, 2024
• Primary Completion: July 6, 2025
• Study Completion: July 6, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)