Diabetic Peripheral Neuropathic Pain (DPN)HBOT-HPLT-DPNNCT07848867
Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy
A study testing Conventional Physiotherapy Program, Hyperbaric Oxygen Therapy and High-Intensity Laser Therapy in people with Diabetic Peripheral Neuropathic Pain (DPN), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPN)
- What is being tested?
- Conventional Physiotherapy Program, Hyperbaric Oxygen Therapy and High-Intensity Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 6 Jul 2025
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Conventional Physiotherapy Program, Hyperbaric Oxygen Therapy, High-Intensity Laser Therapy
- Keywords
- Hyperbaric Oxygen Therapy, High Power Laser Therapy, Sensorimotor Functions, Nerve Conduction Studies, Michigan Neuropathy Screening Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physiotherapy ProgramOther
Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks)
Hyperbaric Oxygen TherapyDevice
Also called HPOT
100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.
High-Intensity Laser TherapyDevice
Also called HPLT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: High-Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and after 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jul 2024
- Primary completion6 Jul 2025
- Study completion6 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPN)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Mohamed Youssef Khalifa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848867
- Sponsor's protocol ID
- P.T.REC/012/005181
- Acronym
- HBOT-HPLT-DPN
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team to maintain patient privacy and data confidentiality in accordance with institutional guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy Versus High Power Laser Therapy On Sensorimotor Functions In Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07848867
- Acronym / sponsor ID
- HBOT-HPLT-DPN / P.T.REC/012/005181
- Keywords
- Hyperbaric Oxygen Therapy, High Power Laser Therapy, Sensorimotor Functions, Nerve Conduction Studies, Michigan Neuropathy Screening Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 6 Jul 2025 (actual)
- Study completion
- 6 Jul 2025 (actual)
- First posted
- 30 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional Physiotherapy ProgramFoot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks). |
| Hyperbaric Oxygen Therapy (HBOT) | Experimental | Device: Hyperbaric Oxygen TherapyConventional 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. |
| High-Power Laser Therapy (HPLT) | Experimental | Device: High-Intensity Laser TherapyConventional 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Conventional Physiotherapy ProgramFoot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks) | Other | Conventional Physiotherapy |
| Hyperbaric Oxygen TherapyAlso: HPOT100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber. | Device | Hyperbaric Oxygen Therapy (HBOT) |
| High-Intensity Laser TherapyAlso: HPLTMLS 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. | Device | High-Power Laser Therapy (HPLT) |
Primary outcome
Change in Michigan Neuropathy Screening Instrument (MNSI) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team to maintain patient privacy and data confidentiality in accordance with institutional guidelines.
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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 Conventional Physiotherapy Program, Hyperbaric Oxygen Therapy and High-Intensity Laser Therapy in people with Diabetic Peripheral Neuropathic Pain (DPN), run by Cairo University at 1 site in Egypt.
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 8 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 30 Sep 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 Egypt. 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?
Change in Michigan Neuropathy Screening Instrument (MNSI) score (time frame: Baseline and 3 weeks post-treatment). The study lists 13 primary outcomes in all. 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 30 Sep 2026.