Effect of Trans cutaneous Electrical Nerve Stimulation (TENS) on health-related quality of life , Harris hip score and mortality rate in patients after surgical treatment of osteoporotic hip and pre-trochanteric fractures
Effect of Trans cutaneous Electrical Nerve Stimulation (TENS) on health-related quality of life, Harris hip score and mortality rate in patients after surgical treatment of osteoporotic hip and pre-trochanteric fractures
Design
A clinical trial with a control group, with parallel groups, double-blind, non-randomized, on 370 patients.
Settings and conduct
The aim of this study is to investigate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on quality of life, hip function, and mortality in patients after hip and proximal femur osteoporotic fracture surgery on 370 hip and hip fracture surgery patients on Valiasr Hospital. The patients were divided into two intervention groups, control group and random group. All patients received common post-operative supportive treatment after the operation, and the intervention group underwent physiotherapy and TENS for five days. The information of the patients and the criteria required for the study will be analyzed by a questionnaire in months 1, 3, 6, and 12. 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: 1. Osteoporotic hip or proximal femur surgery patients 2. Patients over 50 years old
exclusion criteria: Unwillingness of patients to cooperate
Intervention groups
Intervention group: TENS is applied for 5 days after the operation.
Control group: patients receive standard treatment after surgery without TENS.
Main outcome variables
Quality of Life; Hip function; Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056365N1
Registration date:2022-12-18, 1401/09/27
Registration timing:registered_while_recruiting
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Mohammad reza Bozorgmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
m.bozorgmanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-29, 1401/01/09
Expected recruitment end date
2024-03-28, 1403/01/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Trans cutaneous Electrical Nerve Stimulation (TENS) on health-related quality of life , Harris hip score and mortality rate in patients after surgical treatment of osteoporotic hip and pre-trochanteric fractures
Public title
Effect of Trans cutaneous Electrical Nerve Stimulation(TENS) on fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoporotic hip and pre-trochanteric fractures patients
Over 50 years patients
Exclusion criteria:
Patients with unwillingness to cooperate
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
370
Randomization (investigator's opinion)
Randomized
Randomization description
Non-random sampling will be available. Then, the examined samples in this study will be placed in the investigated groups (control and TENS intervention)
random allocation sequence was done using Random Allocation software. In the software, enter the sample size number (370) and the software randomly divided the numbers from 1 to 370 into two equal groups, A and B, and we considered the numbers A as the control group and B as the TENS group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is double-blind because the participants who receive the intervention are aware of the intervention. 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
2022-04-02, 1401/01/13
Ethics committee reference number
IR.ARAKMU.REC.1401.005
Health conditions studied
1
Description of health condition studied
Osteoporotic hip and femur fractures
ICD-10 code
M16
ICD-10 code description
Osteoarthritis of hip
Primary outcomes
1
Description
Quality of life
Timepoint
1, 3, 6 , 12 month after surgery
Method of measurement
SF36 questionnaire
2
Description
Hip function
Timepoint
1, 3, 6 and 12 month after surgery
Method of measurement
Harris hip score
3
Description
Mortality
Timepoint
Immediately and 1, 3 , 6 , 12 month after surgery
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after receiving the standard post-surgery treatment, physiotherapy is performed by the physiotherapist every morning for 30 minutes with a device with a frequency of 180-250 volts, 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
Taraneh Rezaei
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
Mohammad Reza Bozorgmanesh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
m.bozorgmanesh@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Bozorgmanesh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
m.bozorgmanesh@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Bozorgmanesh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
m.bozorgmanesh@arakmu.ac.ir
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