Investigation and study of the effect of TENS on the management and reduction of pain, as well as the amount of distance and duration of starting patients after hip and proximal femur fracture surgery.
Design
A clinical trial with a control group, with parallel groups, double-blind, non-randomized, on 74 patients.
Settings and conduct
The study is carried out in Valiasr Hospital of Arak. Patients are divided into two groups, tennis and control. The patients are evaluated by VAS score in terms of the amount of pain they feel after surgery, and also the amount of walking in the form of partial weight walker and full weight without walker. The study is double-blind, and the researcher and the data analyst are unaware of the allocation of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients who, according to the clinical and radiographic findings, suffered a fracture in the pelvis or proximal femur.
Exclusion criteria:Patients who do not want to cooperate.
Intervention groups
Four 4 cm2 self-adhesive neuromuscular stimulation electrodes were attached to the skin on both sides of the surgical incision of all participants. Active TENS electrical stimulation is performed every morning for 30 minutes for 5 days and a total of 5 treatments. On the first day of treatment, TENS is provided after the physical therapy session. On days 2 to 5, TENS will be applied during ambulatory exercise (10 to 15 minutes) followed by a seated rest period.
Main outcome variables
The level of pain after surgery is evaluated by VAS score within 5 days and then two weeks and three months after surgery.
The amount of walking in the form of partial weight is evaluated by examining the amount of walking distance of the patient in a limited period with a walker and full weight is also evaluated as the duration of walking for 10 meters without a walker.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230103057034N1
Registration date:2023-05-02, 1402/02/12
Registration timing:registered_while_recruiting
Last update:2023-05-02, 1402/02/12
Update count:0
Registration date
2023-05-02, 1402/02/12
Registrant information
Name
Mohammadreza Rasouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
mrr1996@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of transcutaneous electrical nerve stimulation (TENS) on reduction pain feeling after hip and proximal of femoral fractures surgury
Public title
Effects of transcutaneous electrical nerve stimulation (TENS) on pain due fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who, according to the clinical and radiographic findings, suffered a fracture in the pelvis or proximal femur.
Exclusion criteria:
Patients who die during surgery or after discharge
Patients who do not want to cooperate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be available. Then, the examined samples in this study are placed in the investigated groups (control and TENS intervention) using random allocation of patients. Two-group randomization on the web (www.graphpad.com) is used to create a simple random sequence. Enter the number of the sample size (74) on the website and the software randomly divided the numbers 1 to 74 into two equal groups A and B, and we considered the numbers A as the TENS group and B as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is double-blind because the person collecting the information will not be aware of the group of people. The data analyst will not be aware of the group of people
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Arak University of Medical Sciences
Street address
َArak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.ARAKMU.REC.1400.359
Health conditions studied
1
Description of health condition studied
Osteoporotic hip and femur fractures
ICD-10 code
M80
ICD-10 code description
Osteoporosis with current pathological fracture
Primary outcomes
1
Description
After the surgery, the level of pain is checked with the help of the vas score questionnaire during a 5-day intervention period as explained below: once during the first 24 hours after the surgery, before applying physiotherapy and TENS, and then Immediately before each session of physiotherapy and TENS application, by asking the participant, the intensity of pain at night and at rest, the amount of pain experienced the night before and while resting in bed or sitting in a chair during the day is evaluated.In the following, the pain level is assessed once in two weeks after the surgery when the patient visits the orthopedic clinic. Also, the pain level will be measured once with the help of VAS 3 months after the surgery.
Timepoint
once during the first 24 hours after the surgery, before applying physiotherapy and TENS, and then Immediately before each session of physiotherapy and TENS application, by asking the participant, the intensity of pain at night and at rest, the amount of pain experienced the night before and while resting in bed or sitting in a chair during the day is evaluated.In the following, the pain level is assessed once in two weeks after the surgery when the patient visits the orthopedic clinic. Also, the pain level will be measured once with the help of VAS 3 months after the surgery.
Method of measurement
VAS questionnaire to measure the pain level of patients: Visual analog scale (VAS) is a tool that is widely used to measure pain. The patient is asked to indicate their perceived pain intensity (usually) along a 100 mm horizontal line and this rating is then measured from the left edge (= VAS score). VAS score correlates well with acute pain level
Secondary outcomes
1
Description
Partial weight walking
Timepoint
Before discharge
Method of measurement
The amount of distance traveled in two minutes
2
Description
Full weight walkinf
Timepoint
After discharg
Method of measurement
The time required to reach the full weight setup of 10 steps
Intervention groups
1
Description
Intervention group: In the intervention group, after receiving the standard post-surgery treatment, physiotherapy with a device with a frequency of 180-250 volts is performed every morning for 30 minutes by a physiotherapist, depending on the patient's tolerance. Each treatment session includes transfer training, balance exercises, lower limb exercises and ambulatory exercises that are performed at the end of the session. Before walking, four self-adhesive neuromuscular stimulation electrodes measuring 4 square centimeters are attached to the patient's skin on both sides of the surgical incision. Electrical stimulation (TENS) is performed every morning for 30 minutes for 5 days. On the first day, TENS treatment is provided after the physiotherapy session. On days 2 to 5, TENS is applied during ambulatory exercise (10 to 15 minutes) and a seated rest period afterward.
Category
Treatment - Other
2
Description
Control group: patients in the control group only receive the standard treatment of postoperative patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mohammad Reza Rasouli
Street address
Valiasr Hospital ,Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Rasouli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr Squre, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
mrr1996@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Rasouli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr Squre, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
mrr1996@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Rasouli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr Squre, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
mrr1996@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