The effect of Dynamic Neuromuscular Stabilization and Pelvic Floor Training on pain and pelvic floor muscle function in women with Non-Specific Chronic Low Back Pain and Stress Urinary Incontinence
Evaluation of the Effect of Dynamic Neuromuscular Stabilization and Pelvic Floor Exercises on Non-Specific Chronic Low Back Pain and Stress Urinary Incontinence In Women
Design
A randomized clinical trial with a control group and two intervention groups, without blinding, will be conducted on 30 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
Location: Arak University
Method: Randomized, controlled clinical trial
Participants: Women with non-specific chronic back pain and stress urinary incontinence
Intervention: Dynamic neuromuscular and pelvic floor stability exercises
Intervention group 1: neuromuscular dynamic stability training
Intervention group 2: Neuromuscular and pelvic floor dynamic stability training
Control group: pelvic floor exercises
Evaluations:
Severity of back pain
Stress urinary incontinence
Quality of Life
Participants/Inclusion and exclusion criteria
This study seeks women with chronic low back pain and incontinence for an exercise intervention. Inclusion criteria: 2 vaginal deliveries max, 30-40 years old, BMI < 35, mild/moderate pain, diagnosed incontinence. Exclusion criteria: various medical conditions, limitations, or unwillingness to exercise.
Intervention groups
The study will involve 30 participants randomly assigned (10 per group) to one of three groups:
* Group 1: Pelvic Floor Exercises (control group)
* Group 2: Neuromuscular Dynamics Stability Exercises (DNS)
* Group 3: Combination of DNS and Pelvic Floor Exercises
Main outcome variables
Non-specific Chronic Low Back Pain and Stress Urinary Incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240326061368N1
Registration date:2024-08-31, 1403/06/10
Registration timing:retrospective
Last update:2024-08-31, 1403/06/10
Update count:0
Registration date
2024-08-31, 1403/06/10
Registrant information
Name
Shahnaz Shahrjerdi
Name of organization / entity
Arak university
Country
Iran (Islamic Republic of)
Phone
+98 86 3405 6452
Email address
m.babaei.01@msc.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
2024-07-22, 1403/05/01
Actual recruitment end date
2024-08-22, 1403/06/01
Trial completion date
2024-11-20, 1403/08/30
Scientific title
The effect of Dynamic Neuromuscular Stabilization and Pelvic Floor Training on pain and pelvic floor muscle function in women with Non-Specific Chronic Low Back Pain and Stress Urinary Incontinence
Public title
Investigating the effect of neuromuscular and pelvic floor dynamic stability exercises on non-specific chronic back pain and stress urinary incontinence in women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Maximum of 2 natural births
Age range 30 to 40 years
Body mass index up to 35
Having non-specific chronic back pain with mild to moderate intensity
Has stress urinary incontinence
Exclusion criteria:
Women with persistent back pain and a pain score of more than 8
History of urinary and kidney infection and spinal inflammation and infection
Dislocations
Neurological bladder
Hormonal treatments
Excessive obesity (grade 2)
Spinal stenosis or nerve compression or disc herniation
Inflammatory rheumatic diseases
History of hip or spine fracture
Osteoporosis
Ankylosing spondylitis
Spondylosis
Neoplasm
Spondylolisthesis
Sacroiliac joint disorder
Smoking or alcohol consumption
Diabetes
Those who cannot do the exercises or do not want to do the exercises
Spine or pelvic floor surgeries
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We prepare a list of people who have the conditions to enter the study. People are placed in blocks of three and a lottery is done for each block. The first person of each block is in the control group, the second person is in the group of neuromuscular dynamics exercises and the third person is in the group of neuromuscular dynamics stability exercises along with pelvic floor exercises.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Using neuromuscular and pelvic floor dynamic stability exercises
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University
Street address
The University of Arak , Karbala BLV , Basij Square , Arak
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.ARAKU.REC.1402.085
Health conditions studied
1
Description of health condition studied
Chronic non-specific back pain and stress urinary incontinence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chronic non-specific back pain
Timepoint
The beginning and end of the study
Method of measurement
VAS questionnaire and electromyography device Myotrac Infinity model made in Canada
2
Description
Stress urinary incontinence
Timepoint
The beginning and end of the study
Method of measurement
Brawley's Urinary Incontinence Questionnaire(QUID) and one-hour test pad
Secondary outcomes
1
Description
Pain
Timepoint
Before starting the intervention, 8 weeks after the intervention
Method of measurement
Visual Analog Scale questionnaire
Intervention groups
1
Description
Group 1:Dynamic Neuromuscular Stabilization Exercises: One of the newest sports rehabilitation techniques is Dynamic Neuromuscular Stabilization (DNS). The DNS treatment method is based on a detailed assessment of the quality of stability and movement, and the purpose of these exercises is to restore the spinal integration system (ISSS) through specific functional exercises based on evolved kinesiology positions. These exercises should activate the optimal patterns necessary for stabilization (support) in the closed kinetic chain as well as dynamic movements in the open kinetic chain. The ultimate strategy in these exercises is to maintain central control, joint stability, and ideal quality of movement. By repeating the exercises, an automatic pattern is created, which becomes an essential part of everyday movement and skills. The exercises will be done for 8 weeks, 3 times a week for 45 to 60 minutes.
Category
Rehabilitation
2
Description
Group 2: A combination of neuromuscular dynamic stability exercises and pelvic floor exercises: pelvic floor or Kegel exercises are those exercises that strengthen the pelvic floor muscles and help control the flow of urine and prevent involuntary leakage of urine. to be Kegel exercises include movements that help strengthen the muscles of the pelvic floor by tightening and then relaxing them and make them maintain their strength, just as other muscles in the body are strengthened by lifting weights. Doing Kegel exercises is a way to be strong. Keeping the pelvic floor muscles. These exercises will be done 3 times a week for 45 to 60 minutes for 8 weeks.
Category
Rehabilitation
3
Description
Intervention group: pelvic floor exercises: the control group will only perform pelvic floor exercises. These exercises will be performed for 8 weeks, 3 sessions per week for 45 to 60 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Madaen Physiotherapy
Full name of responsible person
Dr. Samira Shahrjerdi
Street address
Madaen Physiotherapy Center, Shokraee Street , Arak
City
Arak
Province
Markazi
Postal code
3813665577
Phone
+98 86 3222 7577
Email
shahrjerdi.s@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Arak
Full name of responsible person
Hamed safikhani
Street address
Faculty of Sports Sciences, Department of Sports Pathology and Sports Physiology, Karbala Blvd, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 2000
Email
d-research@araku.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?