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Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neurodynamic Mobilization Techniques
Selected Physical Therapy Program
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.

Eligibility Criteria

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Inclusion Criteria: 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. Exclusion Criteria: Uncontrolled T2DM and diagnosed with T2DM for < 10 years. Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.

Sites / Locations

  • October 6 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

The NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques.

The participants only received a selected therapy program similar to the NMG with no change in duration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
November 16, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05628168
Brief Title
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Official Title
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The participants only received a selected therapy program similar to the NMG with no change in duration.
Intervention Type
Other
Intervention Name(s)
Neurodynamic Mobilization Techniques
Intervention Description
The slider neurodynamic technique for the median nerve is conducted.Tensioner neurodynamic technique for the tibial nerve is conducted.
Intervention Type
Other
Intervention Name(s)
Selected Physical Therapy Program
Intervention Description
The participants only received a selected therapy program similar to the NMG with no change in duration.
Primary Outcome Measure Information:
Title
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy
Description
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.
Time Frame
5-6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Uncontrolled T2DM and diagnosed with T2DM for < 10 years. Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
Facility Information:
Facility Name
October 6 University
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
1133
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy

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