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Protocol summary

Study aim
The effect of adding electrical stimulation to trunk focused exercises on pain, disability, quality of life, functional and psychological factors of elderly women with chronic non-specific low back pain.
Design
A clinical trial with a control group and two experimental groups, double-blind, randomized on the procedure of 36 patients, sealed envelopes were used for randomization.
Settings and conduct
Practice at home 36 people will be randomly divided into two experimental groups and one control group. Interventions were taught to each person individually with the help of an examiner. The randomization sequence will not be revealed until baseline assessments are completed, and the evaluator and biostatistician will be blinded to group assignment. Patients will be aware of the type of study but will not know which group they are in.
Participants/Inclusion and exclusion criteria
A) Inclusion Elderly women 60-70 years old Elderly women with non-specific chronic back pain for at least 3 months. Normal pain intensity is 3-8 on the visual pain scale Elderly women without the use of walking aids b) Exclusion Diagnosis of serious spinal cord injury • Fracture • Metastatic disease •Spinal stenosis or cauda equina syndrome Evidence of nerve root damage Any medical illness or disability that prevents participation in an exercise program, including: cardiovascular risk factors High risk of falling, with a score of more than 15 on the fall risk assessment
Intervention groups
Adding electrical stimulation to trunk-focused exercises, which will include two experimental groups (first group: trunk-focused exercises with electrical stimulation, second group: trunk-focused exercises alone) and a control group.
Main outcome variables
1-pain, 2-disability, 3-quality of life, 4-functional and psychological factors

General information

Reason for update
End of probation
Acronym
IRCT registration information
IRCT registration number: IRCT20240718062457N1
Registration date: 2024-08-08, 1403/05/18
Registration timing: prospective

Last update: 2025-02-05, 1403/11/17
Update count: 1
Registration date
2024-08-08, 1403/05/18
Registrant information
Name
Shima Hazareh
Name of organization / entity
University of kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 902 423 3628
Email address
shimahazareh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-18, 1403/05/28
Expected recruitment end date
2024-09-19, 1403/06/29
Actual recruitment start date
2024-08-10, 1403/05/20
Actual recruitment end date
2024-09-05, 1403/06/15
Trial completion date
2024-11-13, 1403/08/23
Scientific title
The effect of adding electrical stimulation to trunk-focused exercises on pain, disability, Quality of Life, functional and psychological factors in the elderly women with chronic non-specific low back pain
Public title
The effect of electrical stimulation and focused trunk exercises on chronic non-specific low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women 60-70 years old Elderly women with non-specific chronic back pain for at least 3 months Normal pain intensity 3-8 on the visual pain scale Elderly women without using walking aids Sufficient ability to understand concepts to understand practice instructions
Exclusion criteria:
diagnosis of serious injury in the spine• Fracture• Metastatic disease• Spinal canal stenosis or cauda equina syndrome Evidence of nerve root damage Any medical illness or disability that prevents participation in the exercise program, including: cardiovascular risk factors Cognitive limitations, with a score less than 25/30 in the mental status test high risk of falling, with a score of more than 15 in the fall risk assessment Physiotherapist treatment for non-specific chronic back pain in the previous 6 months
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of this study was made up of elderly women suffering from non-specific chronic back pain aged 60-70 years. The sample size of the study, based on the inclusion criteria in a targeted manner, using G*Power 3.1.7 software, considering the power of 80% (1-β error probability) and α equal to 0.05 and the effect size 0.25 and with Considering 20% ​​dropout was randomly estimated in 3 groups with a total of 36 people, then the samples were asked to be assigned by choosing the numbers 1 to 36 (which were previously prepared by the instructor and placed in the envelope) (12 the number corresponding to the control group and 12 numbers corresponding to the group of electrical stimulation combined with exercises focused on the trunk and 12 numbers corresponding to the group focused on the trunk exercises alone), each person randomly chooses a paper and enters the corresponding group randomly .
Blinding (investigator's opinion)
Double blinded
Blinding description
. The randomization sequence will not be revealed until baseline assessments are completed, and the assessor and biostatistician will be blinded to group allocation. Patients will be aware of the type of study but will not know which group they are in. The groups present in the study will be monitored by the researcher (specialist in corrective movements). It should be noted that all participants will be selected based on the criteria for entering and exiting the research.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kharazmi Uunivercity
Street address
No. 49. Shahid Mofatteh Str. KHarazmi Univercity
City
Tehran
Province
Tehran
Postal code
14911-15719
Approval date
2024-07-06, 1403/04/16
Ethics committee reference number
IR.KHU.REC.1403.056

Health conditions studied

1

Description of health condition studied
Chronic non-specific back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Pain
Timepoint
Before starting the pre-test intervention and after eight weeks of therapeutic interventions for the groups, the post-test was conducted.
Method of measurement
Visual scale of pain (VAS)

2

Description
Disability
Timepoint
The beginning of the study and the end of the study
Method of measurement
Rowland and Morris Disability Questionnaire (RMQ)

3

Description
Quality of Life
Timepoint
The beginning of the study and the end of the study
Method of measurement
36-question quality of life questionnaire (SF-36)

4

Description
Function
Timepoint
The beginning of the study and the end of the study
Method of measurement
McGill performance tests

5

Description
Psychological factors
Timepoint
The beginning of the study and the end of the study
Method of measurement
During this study, to investigate the psychological factors of fear of movement, pain catastrophizing scale, fear avoidance beliefs, automaticityTSK-11, PCS, FABQ, PSEQ, BAI questionnaires will be used respectively for pain and depression.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The treatment consisted of a combination of heat and TENS using two non-stick electrodes. The group that will receive electrical stimulation was placed by the relevant specialist at opposite points (left/right) on the spinal level, which is related to the pain complaint. To control for weight intolerance, participants could choose whether or not they could lie down during the intervention. They were taught how to use the device daily for 30 minutes (2 to 15 minutes) individually and in person. Written instructions were also provided. The following TENS parameters were used: pulse frequency from 0.7 to 1.8 Hz and pulse width of 100 microseconds. The intensity level was ordered to be tolerable. Participants in the experimental groups of core stability exercises, also known as trunk-focused exercises, received a classical core stability training program. Central stability exercises include the plank, single leg butt bridge, side plank, double leg butt bridge and birddog. The exercise program was carried out during 8 weeks, three times a week and each session lasted 30 minutes. One-leg and two-leg butt bridge exercises and birddog exercises were performed for 4 sets of 8-12 each, and plank and side plank exercises were performed for 4 sets of 20-40 seconds each. As people progressed, repetitions and times increased. Electrical stimulation was repeated 3 times every week for 8 weeks after central stability exercises in the respective group.
Category
Rehabilitation

2

Description
Intervention group: Participants in the experimental groups of core stability exercises, also known as trunk-focused exercises, received a classical core stability training program. Core stability exercises include the plank, single leg butt bridge, side plank, double leg butt bridge and birddog. The exercise program was carried out during 8 weeks, three times a week and each session lasted 30 minutes. One-leg and two-leg butt bridge exercises and birddog exercises were performed for 4 sets of 8-12 each, and plank and side plank exercises were performed for 4 sets of 20-40 seconds each. As people progressed, reps and times were upgraded.
Category
Rehabilitation

3

Description
Control group: They will remain without any intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Mojtaba Physiotherapy Clinic
Full name of responsible person
Sadrodin Shojaodin
Street address
Shahid Madani Alley, Mojtaba Physiotherapy Clinic, Nazarabad Town
City
Nazarabad
Province
Alborz
Postal code
333-1775-338
Phone
+98 902 423 3628
Email
Shima.hezareh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi Univercity
Full name of responsible person
Mohammad Delnavaz
Street address
Shahid Beheshti Street, University Square, Kharazmi University
City
Karaj
Province
Alborz
Postal code
15719-37551
Phone
+98 26 3457 9600
Email
info@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi Univercity
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
The Univercity of Kharazmi
Full name of responsible person
Shima Hazareh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and corrective movements
Street address
No. 12, Mahestan3 Ally.
City
Nazarabad
Province
Alborz
Postal code
333-1775-338
Phone
+98 902 423 3628
Email
shimahazareh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Univercity of Kharazmi
Full name of responsible person
Sadrodin Shojaodin
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Pathology and Corrective Movements
Street address
Tehran, Mirdamad Blvd., South Razan St., Shahid Kishori Educational-Sports Complex
City
Tehran
Province
Tehran
Postal code
15719-37551
Phone
00980125073897
Email
sa_shojaedin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The Univercity of Kharazmi
Full name of responsible person
Shima Hazareh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
No. 12, 3 Mehestan Alley, Palestine St
City
Nazarabad
Province
Alborz
Postal code
333-1775-338
Phone
+98 902 423 3628
Email
shimahazareh@gmail.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
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