Diabetic NeuropathiesNCT05628168
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
A study testing Neurodynamic Mobilization Techniques and Selected Physical Therapy Program in people with Diabetic Neuropathies, run by October 6 University at 1 site in Egypt.
Trial summary
Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Neurodynamic Mobilization Techniques and Selected Physical Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2021to 2 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.
- The participants regularly took their diabetes medications during the assessment and treatment period.
Who cannot join
- Uncontrolled T2DM and diagnosed with T2DM for < 10 years.
- Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.
Read the detailed description
Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.
- Conditions
- Diabetic Neuropathies
- Being tested
- Neurodynamic Mobilization Techniques, Selected Physical Therapy Program
- Keywords
- Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic Mobilization TechniquesOther
The slider neurodynamic technique for the median nerve is conducted.Tensioner neurodynamic technique for the tibial nerve is conducted.
Selected Physical Therapy ProgramOther
The participants only received a selected therapy program similar to the NMG with no change in duration.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques. Receives: Other: Neurodynamic Mobilization Techniques; Other: Selected Physical Therapy Program |
| Group B | Active comparator | The participants only received a selected therapy program similar to the NMG with no change in duration. Receives: Other: Selected Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
This study aimed to investigate neurodynamic mobilization effect on sensory and motor nerve conduction study, pain, and functional activity in patients with type 2 diabetic neuropathy and will be assessed through Katz index and NIHON KODEN EMG device.
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start5 Dec 2021
- Primary completion10 May 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- 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
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Alshimy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628168
- Sponsor's protocol ID
- P.T.REC/012/003496
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05628168
- Acronym / sponsor ID
- P.T.REC/012/003496
- Conditions
- Diabetic Neuropathies
- Keywords
- Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 28 Nov 2022 (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.
Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.
Detailed description
Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Neurodynamic Mobilization Techniques, Other: Selected Physical Therapy ProgramThe NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques. |
| Group B | Active comparator | Other: Selected Physical Therapy ProgramThe participants only received a selected therapy program similar to the NMG with no change in duration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.
- The participants regularly took their diabetes medications during the assessment and treatment period.
Key exclusion criteria (2 listed)
- Uncontrolled T2DM and diagnosed with T2DM for < 10 years.
- Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
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 |
|---|---|---|
| Neurodynamic Mobilization TechniquesThe slider neurodynamic technique for the median nerve is conducted.Tensioner neurodynamic technique for the tibial nerve is conducted. | Other | Group A |
| Selected Physical Therapy ProgramThe participants only received a selected therapy program similar to the NMG with no change in duration. | Other | Group A, Group B |
Primary outcome
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Time frame: 5-6 months
This study aimed to investigate neurodynamic mobilization effect on sensory and motor nerve conduction study, pain, and functional activity in patients with type 2 diabetic neuropathy and will be assessed through Katz index and NIHON KODEN EMG device.
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 28 Nov 2022.
- Individual participant dataSharing planned: No
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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 Neurodynamic Mobilization Techniques and Selected Physical Therapy Program in people with Diabetic Neuropathies, run by October 6 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 2 inclusion and 2 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 28 Nov 2022. 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?
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy (time frame: 5-6 months). 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 28 Nov 2022.