Comparison of the effect of exercise therapy with electroacupuncture with exercise therapy with electrical percutaneous nerve motility on pain, physical function and gait in people with complete hip arthroplasty
Comparison of the effect of exercise therapy with electroacupuncture with electrical stimulation of percutaneous nerve along with exercise therapy on pain, physical function and walking speed in people with complete hip arthroplasty.
Design
Clinical trial with control group, with parallel groups, double-blind, non-randomized, on 20 patients. 1 phase
Settings and conduct
At home, electroacupuncture and TENS interventions and exercise therapy will be performed. Participant, therapist and blind evaluator. The participant is aware of the inclusion in the study and fills out the satisfaction form. The therapist only knows what he is going to do. The evaluator also has no knowledge of the study groups.
Participants/Inclusion and exclusion criteria
People who have had hip arthroplasty and are over 60 years old and also do not have any specific infections and do not have an underlying disease who is taking pain medication.
Intervention groups
Electroacupuncture with regular exercise therapy for one group and TENS intervention with exercise therapy for the other group
Main outcome variables
Reduce pain, reduce edema, increase physical function and gait in people with hip arthroplasty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045652N4
Registration date:2021-11-04, 1400/08/13
Registration timing:prospective
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
marzieh Yassin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
m.yassin.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of exercise therapy with electroacupuncture with exercise therapy with electrical percutaneous nerve motility on pain, physical function and gait in people with complete hip arthroplasty
Public title
The effect of electroacupuncture and exercise therapy on pelvic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hip arthroplasty surgery one to two days after surgery
People aged 60 and over
The surgical incision is anterior-external and the head of the hip bone and acetabulum have been replaced
Patients' pain at the time of initial evaluation after surgery should be at least 3 cm based on a numerical pain rating scale
Ability to read and write in cycles
Ability to walk at least 50 meters
History of neurological diseases that cause patients to be unable to function
Exclusion criteria:
Re-hip surgery
Existence of infection after hip replacement surgery
Partial loss of hip or acetabulum during study due to interventions
History of using painkillers that are outside the treatment regimen of a specialist physician while studying or are different from other painkillers used by other patients
Patients with diabetes, etc. who use painkillers to reduce joint pain
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the therapist, and the person evaluating the participants go blind. Of course, participants are given enough information about how to enter the study first and they are explained. For physiotherapist, which also uses electroacupuncture or exercise therapy, it is blinded to prevent bias for interventions. Outcome assessment is also done for the person who does not know which group the participant is in and wants to score based on guesswork.
Placebo
Used
Assignment
Parallel
Other design features
In this study, for the first time, electroacupuncture for people who have had hip arthroplasty is examined to measure its effects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
In this study, the amount of pain is the primary outcome variable because the sample size and inclusion criteria are determined based on this variable.
Timepoint
Days 1, 5, 15 and 30 of the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Physical function
Timepoint
Days 1, 5, 15 and 30 of the intervention
Method of measurement
Hip Disability and Osteoarthritis Outcome Score (HOOS), Three tests of maximum walking speed, 3-minute walking test and sitting and standing up test
2
Description
edema of the entire lower limb
Timepoint
Days 1, 5, 15 and 30 of the intervention
Method of measurement
Using a tape measure, the edema of the entire lower limb is measured in areas 10 cm above the knee joint, the middle part of the leg as well as the middle area of the foot.
3
Description
Hip Range of motion
Timepoint
Days 1, 5, 15 and 30 of the intervention
Method of measurement
A goniometer is used to measure the range of motion of the hip joint.
Intervention groups
1
Description
Intervention group: the intervention group, the first session of treatment will use electroacupuncture along with exercise therapy.DZ-II NERVE AND MUSCLE STIMILATOR made in China in 2016 will be used.Sterile disposable needles with a diameter of 0.25 mm and a length of 50 mm will be used by the SMS company South Korea, produced in 2019. Electroacupuncture device settings include 2 Hz frequency, conventional mode, duration 20 minutes. The needles are attached to the device and attach to 10 points on the body.
Category
Treatment - Other
2
Description
Control group: In the control group, the first session will use TENS. In this group, 10 sessions of exercise therapy with electrical stimulation through the skin with the help of the SDZ-II NERVE AND MUSCLE STIMILATOR device Made in China, it is used in the area of pain. While the supine patient is lying on the bed, the 4 electrodes of the device are closed diagonally in the patient's pain range, electrical stimulation with a frequency of 100 Hz is applied for 20 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Marzia Yassin
Street address
Hemmat Gharb Highway, after Sattari Highway, south of Shahid Kabiri Tameh St. (North Shahin), Bahar St., No. 15, floor
City
Tehran
Province
Tehran
Postal code
2144491602
Phone
+98 21 4448 0185
Fax
+98 21 4449 2187
Email
info@hospitalomid.com
Web page address
https://omid.hospital/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, 5-th floor of the headquarters
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 5503
Email
Research-m@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Marzia Yassin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sattar Khan Street. Nyayesh Street. Rasoul Akram Hospitalو Physiotherapy department
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 2222 8052
Email
m.yassin.pt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzia Yassin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sattar Khan Street. Nyayesh Street. Rasoul Akram Hospitalو Physiotherapy department
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 2222 8052
Fax
+98 21 8862 2703
Email
m.yassin.pt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzia Yassin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sattar Khan Street. Prayer Street. Rasool Akram Hospital. Physiotherapy department
City
Tehran
Province
Tehran
Postal code
۴۴۹۶۱۴۵۳۵
Phone
+98 21 2222 8052
Email
yassin.m@iums.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