Protocol summary

Study aim
The effects of transcranial alternative current stimulation on pain, central sensitization and functional disability in individuals with chronic low back pain: double-blind randomized clinical trial
Design
Clinical trial, factorial, double-blind, randomized, 3 phase on 54 patient. For randomization random allocation software was used.
Settings and conduct
In this study, the intensity of pain and the level of sensitivity of people to pressure stimuli, the sequence of muscle activation during rapid shoulder flexion will be measured before the study, immediately after and 4 weeks after the end of the treatment. This study will be conducted in the Science and Research Center of Shiraz Rehabilitation Faculty located in Chamran Hospital. The study is double-blind and the evaluator (researcher), clinical caregiver (project partner) and participants will be unaware of how the study was conducted.
Participants/Inclusion and exclusion criteria
age between 18-65, having low back pain for at least three months ago, pain intensity more than equal to 3 in the last week; radicular pain in legs, symptoms of serious underlying conditions such as tumor, infection, vertebral compression fracture, ankylosing spondylitis or spinal stenosis, pregnancy, any contraindication use of transcranial alternative current stimulation
Intervention groups
the routine physical therapy treatment group (transcutaneous electrical nerve stimulation, Hot pack, Ultrasound, Exercise), the transcranial alternating current stimulation treatment group, the routine physical therapy and transcranial alternating current stimulation treatment group
Main outcome variables
pressure pain threshold, temporal summation of pain, conditioned pain modulation, delayed onset of muscle activity, recruitment of muscle activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240508061710N1
Registration date: 2024-05-18, 1403/02/29
Registration timing: prospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Zeinab Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 5768
Email address
zeinabmohammadi35@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-15, 1403/03/26
Expected recruitment end date
2024-12-16, 1403/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of transcranial alternative current stimulation on pain, central sensitization and functional disability in individuals with chronic low back pain: double-blind randomized clinical trial
Public title
the effects of brain stimulation on pain and disability in individuals with chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ََAge between 18-65 Duration of chronic low back pain for at least three months before entering the study، since one year ago Pain severity more than equal to 3 on a 0-10 numerical pain rating scale since 7 days before first assessment
Exclusion criteria:
Changes in drug and non-drug treatments since 1 month ago (before entering the study) Neuralgia or radicular pain at legs History of cardiovascular disease that cause disruption of physical function Using cardiac pacemaker, defibrillator or other metallic or electronic devices Symptoms of serious underlying conditions such as tumor, infection, vertebral compression fracture, ankylosing spondylitis or spinal stenosis Presence of nerve or tissue damage that affects pressure pain threshold measurement locations Uncontrolled diabetes Any history of neurological or psychological problems that prevent people from participating in the test or cause a person's physical or mental dysfunction Pregnant or until 1 year postnatal Any contraindication use of of transcranial alternative current stimulation such as history of neurological diseases, open wounds on the scalp and/or face. evidence of a developmental learning disability, a history of alcohol and/or substance abuse
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of people to three groups of random samples taken from patients is done completely randomly. Randomization is done based on the random allocation software in a block method with the size of each block being 6. To implement random allocation concealment, non-transparent envelopes sealed with random sequence will be used so that the allocated group is not known before individual allocation. In this method, after generating a random sequence using the block method, based on the specified sample size, a number of envelopes with non-transparent cover are prepared (in order to make the content of the envelopes unclear) and each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of eligible participants for the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are unaware of the allocation of people to different treatment groups, and the clinical caregiver who will be the student's colleague in this study will be unaware of the evaluation method and the outcomes to be evaluated. The outcome assessor, who is the main researcher or student in this study, will be completely unaware of the type of group to which each participant has been assigned.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Imam Hassan Dormitory, Rudaki 2, 36 Alley, Zand St.
City
Shiraz
Province
Fars
Postal code
7135744481
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.SUMS.REC.1403.017

Health conditions studied

1

Description of health condition studied
chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
pressure pain threshold
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Digital algometer

2

Description
Temporal summation of pain
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Math formula

3

Description
Conditioned pain modulation
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Math formula

4

Description
Delayed onset of muscle activity
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Surface electromyography

5

Description
Recruitment of muscle activity
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Surface electromyography

6

Description
Pain intensity
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Numeric Rating Scale

7

Description
The degree of functional disability
Timepoint
Before the first session of treatment, after the tenth session of treatment and four weeks after the end of treatment
Method of measurement
Oswestry Disability Index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: routine physical therapy (Transcutaneous electrical nerve stimulation, Hot pack, Ultrasound, Exercise)
Category
Treatment - Devices

2

Description
Second intervention group: Transcranial Alternating Current Stimulation
Category
Treatment - Devices

3

Description
Third intervention group: routine physical therapy (Transcutaneous electrical nerve stimulation, Hot pack, Ultrasound, Exercise) and Transcranial Alternating Current Stimulation
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
chamran Hospital
Full name of responsible person
Seyyed Abbas Rakhsha
Street address
Chamran hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۸۱۵۶۴۴
Phone
+98 71 3624 0101
Fax
+98 71 3623 4507
Email
chamranlb1@sums.ac.ir
Web page address
https://chamran.sums.ac.ir/

2

Recruitment center
Name of recruitment center
Imam Reza and Shahid Motahari specialized and super specialized clinic complex
Full name of responsible person
Zohreh Sadeghi
Street address
Namazi Square, next to Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
محمدهاشم هاشم پور
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Razeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, after Amirul Mominin Burn Accident Hospital, Sadra City Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
razeghm@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Razeghi
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, after Amirul Mominin Burn Accident Hospital, Sadra City Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
razeghm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Emamhasan dormitory ,2 Rudaki, 36 Zand, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7135744481
Phone
+98 71 3231 5768
Fax
Email
zeinabmohammadi35@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
Not applicable
Data Dictionary
Not applicable
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