Comparing the effects of active and passive mobilization of tibial nerve on pain intensity and conduction velocity of tibial nerve in neuropathy of type 2 diabetic patients
Comparing the effects of active and passive mobilization of tibial nerve in neuropathy of type 2 diabetic patients
Design
Clinical trial with two parallel groups;
Single-blind;
Sample size will be extracted through a pilot study;
Randomization: Patients are randomly assigned to one of the two groups: active or passive neurodynamics by selecting one of the sealed envelopes that are related to the determination of the groups
Settings and conduct
The work is carried out at Deziani Hospital and has two groups: active neurodynamics and passive neurodynamics. The number of treatment sessions is 15 sessions, both treatment groups receive cutaneous nerve stimulation for 20 minutes in the sole of the foot as a basic treatment. Blinding is such that patients are unaware of which treatment group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women; with type 2 diabetes; in the age group of 40-75 years; passing at least 2 years since the onset of diabetes and 6 months since the onset of neuropathy symptoms (severity: grade 1 and 2 neuropathy by monofilament instrument, Michigan questionnaire and tibial nerve conduction velocity examination that is above 40 m/s);
leg pain of 3 or more in the VAS scale.
Exclusion criteria: diabetic foot ulcer; irritable pain; lack of cooperation or understanding in sensory testing or manual therapy; drug or alcohol dependence; lumbar disc herniation; damage to the nerves of the lower extremities; the presence of retinopathy; history of cardiovascular disease; musculoskeletal deformity
Intervention groups
Intervention group1: physiotherapist performs passive neurodynamic of tibial nerve with 10 repetitions;
Intervention group 2 :active neurodynamics of the tibial nerve performed by the patient himself 10 times.
Main outcome variables
Score of Michigan questioner; quality of life questioner; pain intensity;
tibial nerve conduction velocity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220216054035N2
Registration date:2025-08-05, 1404/05/14
Registration timing:prospective
Last update:2025-08-05, 1404/05/14
Update count:0
Registration date
2025-08-05, 1404/05/14
Registrant information
Name
Monire Alem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3327 5887
Email address
monireaalem@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-09-03, 1404/06/12
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of active and passive mobilization of tibial nerve on pain intensity and conduction velocity of tibial nerve in neuropathy of type 2 diabetic patients
Public title
The effects of active and passive mobilization of tibial nerve in neuropathy of type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Passing at least 2 years since the onset of diabetes
Their leg pain is 3 or higher
Their blood sugar levels are in the range of 100-250
It has been 6 months since the onset of neuropathy symptoms
Men and women with type 2 diabetes
In the age group of 40-75 years
Grade 1 and 2 neuropathy via monofilament instrument, Michigan questionnaire, and tibial nerve conduction velocity assessment
Exclusion criteria:
Diabetic foot ulcer
Irritable pain
Lumbar disc herniation
Damage to the nerves of the lower extremities
History of cardiovascular disease
Musculoskeletal deformity
Lack of cooperation or understanding during sensory testing or manual therapy
Dependency to drug or alcohol
Lumbar disc herniation
Damage to the nerves of the lower extremities
Retinopathy
History of cardiovascular disease
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
1
Both feet of people
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple individual randomization method, patients who meet the study entry criteria after evaluation randomly select one of two types of sealed envelopes, corresponding to the active or passive mobilization method, and thus their type of intervention group is determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of which treatment group they will be placed in.
Participants in two different groups will be treated at different times so that they do not realize the differences in the treatments through observation and conversation with each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 8, Shams Alley, before Tavanir, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1314744513
Approval date
2024-12-14, 1403/09/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.513
Health conditions studied
1
Description of health condition studied
Neuropathy of diabetes
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Conduction velocity of tibial nerve
Timepoint
Before intervention and end of treatment sessions (19th day)
Method of measurement
Electromyography
2
Description
Pain
Timepoint
Before intervention and end of treatment sessions (19th day)
Method of measurement
Visual analog scale (VAS)
Secondary outcomes
1
Description
Neuropathy score on the Michigan Questionnaire
Timepoint
Before intervention and end of treatment sessions (19th day)
Method of measurement
With Michigan questionnaire, this questionnaire consists of two parts: Part A,ranging from 0 to a score of 13, with a higher score indicating greater severity of neuropathy , and Part B, where a score above 2 indicates neuropathy
2
Description
Quality of life questionnaire score
Timepoint
Before intervention and end of treatment sessions (19th day)
Method of measurement
Quality of life Questionnaire with 15 questions
3
Description
Leg raising range of motion
Timepoint
Before intervention and end of treatment sessions (19th day)
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group 1: Active mobilization of tibial nerve is performed five sessions per week for 3 weeks in supervised manner. To perform the neurodynamic gliding exercise of the tibial nerve: The patient sits in a slump position. In the starting position, the neck, trunk, and knee are in flexion, the ankle is in plantar flexion and inversion, that brings the neck, trunk, and knee into extension and the ankle into dorsiflexion and eversion. This cycle lasts 4 seconds each time and we ask the patient to repeat this 10 times sitting on the bed.
Category
Rehabilitation
2
Description
Intervention group 2: passive mobilization of tibial nerve with the patient in the supine position five sessions per week for 3 weeks. Tibial nerve glide The patient is in the supine position, in the starting position the patient's knee is in extension and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to flexion.Tibial nerve tension with the shock lock method: The patient is in the supine position, in the starting position the patient's knee is in flexion and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to extension. This method is performed 10 times for the patient in each session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Deziani specialized and subspecialty clinic
Full name of responsible person
Monire Alem
Street address
Deziani hospital , in front of Behesht 17, before the three-way Molaghati, Shahid beheshti street
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3223 9571
Fax
Email
deziani@domain.com
Web page address
https://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Deziani hospital , in front of Behesht 17, before the three-way Molaghati, Shahid beheshti street
City
Gorgan
Province
Golestan
Postal code
4916614358
Phone
+98 911 526 4478
Email
monireaalem@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Monire Alem
Position
Doctoral student in physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali hospital, Damavand Street
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7754 2057
Email
monireaalem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Majid Hossaini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali hospital, Damavand Street
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7754 2057
Email
majidhosseini44@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
seyyed Majid Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali hospital, Damavand Street
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7756 2507
Email
majidhosseini44@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Pain intensity
When the data will become available and for how long
Six months after publication of the paper
To whom data/document is available
All people
Under which criteria data/document could be used
People that research in this field
From where data/document is obtainable
Via email:
monireaalem@gmail.com
What processes are involved for a request to access data/document
Send a request via email and state for what purpose he/she need the data.