Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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1-pain, 2-disability, 3-quality of life, 4-functional and psychological factors
General information
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Reason for update
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End of probation
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Acronym
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IRCT registration information
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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
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Registration date
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2024-08-08, 1403/05/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-08-18, 1403/05/28
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Expected recruitment end date
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2024-09-19, 1403/06/29
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Actual recruitment start date
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2024-08-10, 1403/05/20
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Actual recruitment end date
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2024-09-05, 1403/06/15
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Trial completion date
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2024-11-13, 1403/08/23
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Scientific title
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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
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Public title
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The effect of electrical stimulation and focused trunk exercises on chronic non-specific low back pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 60 years old to 70 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
36
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 .
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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. 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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-07-06, 1403/04/16
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Ethics committee reference number
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IR.KHU.REC.1403.056
Health conditions studied
1
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Description of health condition studied
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Chronic non-specific back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before starting the pre-test intervention and after eight weeks of therapeutic interventions for the groups, the post-test was conducted.
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Method of measurement
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Visual scale of pain (VAS)
2
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Description
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Disability
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Timepoint
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The beginning of the study and the end of the study
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Method of measurement
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Rowland and Morris Disability Questionnaire (RMQ)
3
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Description
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Quality of Life
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Timepoint
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The beginning of the study and the end of the study
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Method of measurement
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36-question quality of life questionnaire (SF-36)
4
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Description
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Function
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Timepoint
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The beginning of the study and the end of the study
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Method of measurement
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McGill performance tests
5
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Description
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Psychological factors
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Timepoint
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The beginning of the study and the end of the study
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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Control group: They will remain without any intervention.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi Univercity
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available