The effect of transcutaneous electrical nerve stimulation at acupuncture points on hemodynamic indices and back pain in patients undergoing coronary artery catheterization: a randomized clinical trial
Determining the effect of TENS at acupoints on hemodynamic indices and back pain in patients undergoing coronary artery catheterization
Design
A randomized, double-blind, parallel clinical trial on 80 patients. Randomization was prepared from a sealed opaque envelope and each random sequence was recorded on a card. Randomization with Minitab software
Settings and conduct
In this double-blind study, 80 eligible patients were recruited using consecutive sampling. Random allocation was performed using four-block randomization with allocation concealment via opaque envelopes. Both participants and the data collector were blinded to group assignment, and data were collected blindly.
Participants/Inclusion and exclusion criteria
• Individuals 18-65 years old
• Candidate for coronary angiography
• Candidate for PCI via the femoral artery
• Fully conscious and able to communicate
. normal posterior tibial pulses
Intervention groups
In the intervention group, two 5×5 cm plastic electrodes are placed on pain-relief acupuncture points (GB30 and BL40) on the limb opposite to the Angiography site, and TENS is applied in burst mode at 90 Hz for 20 minutes.
In the control group, electrodes are attached to non-related points (ST36 and SP6), and stimulation is delivered at a low frequency of 20 Hz for 20 minutes.
Main outcome variables
back pain and hemodynamic stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250621066210N1
Registration date:2026-01-04, 1404/10/14
Registration timing:registered_while_recruiting
Last update:2026-01-04, 1404/10/14
Update count:0
Registration date
2026-01-04, 1404/10/14
Registrant information
Name
Abas Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 9620
Email address
shahab.asadi92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-31, 1404/10/10
Expected recruitment end date
2026-02-09, 1404/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcutaneous electrical nerve stimulation at acupuncture points on hemodynamic indices and back pain in patients undergoing coronary artery catheterization: a randomized clinical trial
Public title
The effect of transcutaneous electrical nerve stimulation at acupuncture points on hemodynamic indices and back pain in patients undergoing coronary artery catheterization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for coronary angiography
Candidate for percutaneous coronary intervention via femoral artery
Having full awareness and the power to communicate
Presence of normal posterior tibia pulses
Score higher than 3 for back pain using the NRS tool
People 18 – 65 years old
Exclusion criteria:
Use of antihypertensive medication before and during the study
Use of painkillers before and during the study
Presence of back pain/low back pain in the past week before catheterization
Back pain/low back pain at first evaluation after catheterization
Patients with stroke, psychosis, history of trauma or blows that have caused damage to the limbs and disrupted the patient's sensation and movement.
Complications during angiography, such as hematoma, infection, bleeding, cardiac arrhythmias, and cardiac arrest
Cardiac conduction disorders (may be affected by TENS electrical stimulation)
History of allergies and skin sensitivity in the area where the electrodes are to be placed
The presence of a skin lesion in the area where the electrodes are to be placed
Psychological illnesses leading to patient non-cooperation
History of TENS (due to familiarity with TENS and the possibility of affecting results)
The need for oxygen to follow up on the patient's condition after angiography
Age
From 18 years old to 65 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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used to assign individuals to groups. Randomization is performed by generating random numbers from 1 to 80 (80 is the total number of individuals in the control and intervention groups) and assigning each number to one of the groups. This is done based on the sequence obtained from the software. For example, person number one is placed in the control or intervention group, depending on which group the number 1 is assigned to. Also, during randomization, equal numbers of men and women are assigned to the two groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is triple-blind, meaning that the patients participating in the study are unaware of the type of group assigned (intervention and control). Also, the data collector and analyst will remain blind to the type of group assigned to the patients. Thus, the collection and recording of information including back pain, respiratory rate, pulse, oxygen saturation, and completion of the questionnaires will be done by a second person without knowing the group of individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Shahid Foromandi Street - Foromandi 12
City
اسفراین
Province
North Khorasan
Postal code
9661938944
Approval date
2025-09-08, 1404/06/17
Ethics committee reference number
IR.SHMU.REC.1404.105
Health conditions studied
1
Description of health condition studied
Presence of coronary angioplasty implant and graft
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
2
Description of health condition studied
Backache
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Back pain • Score greater than 3 using the NRS tool
Timepoint
Before the intervention, 2, 4, and 6 hours after the intervention.
Method of measurement
Numerical rating scale
2
Description
Hemodynamic indicators
Timepoint
Before the intervention, 2, 4, and 6 hours after the intervention.
Method of measurement
Intrusive bedside monitoring and assessment device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two 5x5 cm plastic electrodes are placed face to face or side by side at acupuncture points for pain relief (acupuncture points with the highest average effect size scores (GB30 and BL 40) connected to a BURJIS device, model ST90, manufactured in Iran and serial number ST90994090, and the burst mode and frequency will be set to 90 Hz and for a duration of 20 minutes. (The BL 40 point is located below the knee, and the GB30 point is located in the lower outer quarter of the gluteal muscle) and the pads will be attached to the leg opposite the angiography site (two small pads at each site, without the need to change the patient's position).
Category
Treatment - Other
2
Description
Control group: Two 5x5 cm plastic electrodes are attached at unrelated points (ST36, SP6, which have analgesic and anesthetic effects in the pelvic area and analgesia, respectively), and the burst mode and frequency will be set to 20 Hz (the lowest level) and for a duration of 20 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hassan Hospital
Full name of responsible person
Dr. Morteza Safikhani
Street address
Bojnourd, Arkan, Campus of North Khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
94149-74877
Phone
+98 58 3151 0000
Email
info@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
Haft Tir Square.,Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?