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Investigating the effect of adding electroacupuncture to common rehabilitation treatments on improving sensory and motor function and electrophysiological components in spinal cord injury patients

Protocol summary

Study aim
Investigating the effect of adding electroacupuncture to common rehabilitation treatments on improving sensory and motor function and electrophysiological components in spinal cord injury patients
Design
A clinical trial with a control group, double blind, block randomized, including 20 patients
Settings and conduct
Patients in Tehran Rofeydeh Hospital are divided into two groups of 10 people, in both groups, routine rehabilitation and electroacupuncture will be performed, but in the control group, after a few seconds, the device will be turned off and the needles will be removed. Before and immediately after 40 treatment sessions, the patients' sensory and motor function will be evaluated by the ASIA form and their H-reflex components will be recorded. In this study, the therapist, the evaluators, and the researcher are three different people, and the patients, evaluators, and the statistician are blinded.
Participants/Inclusion and exclusion criteria
20 patients with sub-acute spinal cord injury who are admitted to Rofeydeh Hospital for rehabilitation. Admission conditions: subacute traumatic spinal cord injury patients from the thoracic region and in groups B, C, and D (based on the American Spinal Injury Association injury scale). Normal or normal heart, liver and kidney functions as well as coagulation functions. Age 18-45 years. Exclusion criteria: uncontrolled blood pressure, deep vein thrombosis, severe pressure ulcers and cognitive dysfunction. diabetes Hypersensitivity to needles. pregnancy
Intervention groups
Intervention group (1): will receive routine rehabilitation treatment + electroacupuncture. Control group (2): They will receive routine rehabilitation treatment and the received electroacupuncture will be turned off after a few seconds and the needles will be removed.
Main outcome variables
Sensory and motor performance and changes in electrophysiological components

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150602022539N14
Registration date: 2023-02-23, 1401/12/04
Registration timing: registered_while_recruiting

Last update: 2023-02-23, 1401/12/04
Update count: 0
Registration date
2023-02-23, 1401/12/04
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2024-01-04, 1402/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding electroacupuncture to common rehabilitation treatments on improving sensory and motor function and electrophysiological components in spinal cord injury patients
Public title
The effect of electroacupuncture on sensory and motor function and electrophysiological components in spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of Spinal Cord Injury with non-progressive causes characterized by spinal trauma. Neuroimaging tests, such as computed tomography, will be used to rule out more serious, progressive conditions such as nerve-destroying injuries, tumors, and demyelination. Patients with traumatic injury and relatively stable condition after spinal internal fixation surgery. Normal or normal heart, liver and kidney functions as well as coagulation functions. Being mentally and psychologically stable. Age range 18-45 years. Subacute traumatic spinal cord injury patients (maximum 18 months have passed since the injury) from the thoracic region and in groups B,C and D (based on the American Spinal Injury Association injury scale) will be studied.
Exclusion criteria:
Uncontrolled blood pressure, severe heart and lung disease, severe orthostatic hypotension, deep vein thrombosis, severe osteoporosis, severe pressure ulcers and cognitive dysfunction, diabetes, hypersensitivity to needles. Fear of needles. Pregnancy, osteomyelitis of vertebrae, tumor, ankylosing spondylitis. The presence of serious mental injuries such as suicidal thoughts. People suffering from complications such as hematoma or severe pain during the study. Lack of consent to continue the tests. People's inability to continue rehabilitation and intervention due to medical reasons. Participation of individuals in intensive rehabilitation programs that may bias the results will also be excluded.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block Randomization unit: individual Randomization tool: random sequence generation software (Excel) Random Layers: Does not occur How to make a random sequence: The method of allocation to two groups will be Block Permuted Randomization in blocks of 4. Concealment of random allocation: does not take place
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the therapist and the assessor (the one who evaluates the sensorimotor function using the ASIA form and the one who records the H-Reflex components) are different people, and the evaluator does not know what intervention the patient receives and also The statistician is also blind to the data.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road, Semnan
City
Semnan
Province
Semnan
Postal code
5319899951
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.SEMUMS.REC.1401.289

Health conditions studied

1

Description of health condition studied
Spinal Cord Injury
ICD-10 code
S24.0
ICD-10 code description
Concussion and edema of thoracic spinal cord

Primary outcomes

1

Description
ASIA form sensory sub-item score - ASIA form motor sub-item score - H-reflex amplitude - H-reflex latency
Timepoint
Before treatment, immediately after 40 sessions of treatment
Method of measurement
ASIA form EMG recording device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises، The electroacupuncture protocol includes 40 sessions 5 days a week for 8 weeks with a frequency of 1-5 Hz and a pulse width of 100 microseconds with an intensity of 1 to 10 millivolts in the area of ​​GV14, GV9, GV4, GV3, GV20, GV19 and Jiaji will be performed on the top and bottom of the injury site bilaterally for 30 minutes.
Category
Treatment - Devices

2

Description
Control group: The control group will receive common rehabilitation treatment 6 days a week for 8 weeks and electroacupuncture 5 days a week for 8 weeks, but after a few seconds the device will be turned off and the needles will be removed. Common rehabilitation includes that each patient will receive 6 days a week and three sessions of physiotherapy each day for forty-five minutes and one work session for thirty minutes, with at least one hour of rest between sessions. and the exercises will include strengthening exercises, stretching and passive exercises to prevent deformity and maintain joint range and walking exercises.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Rofeydeh Rehabilitation Hospital
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Rofeydeh Rehabilitation Hospital, Shahid Nemati Alley, South Salimi St., Anderzgo Blvd., Ghaitariya,
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Email
ziasafavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Mashahir Square, in front of Helal Ahmar, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3332 2332
Email
ziasafavi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3013138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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