The aim is to determine the effectiveness of Egoscue and NASM exercises with abdominal draw-in maneuvers and compare the efficacy of these methods with each other in women with chronic back pain.
Design
A single-blind, randomized, controlled clinical trial, phase II.
75 women with lordosis angle greater than 35 degrees and suffering from chronic back pain will participate in this study.
Settings and conduct
This study will be conducted in the sports rehabilitation laboratory of Arak University. The participants in this study will have a lumbar lordosis angle higher than 35 degrees and also suffer from chronic back pain. Egoscue and NASM exercises will be performed along with abdominal draw-in maneuver for eight weeks.
Participants/Inclusion and exclusion criteria
Age 18 to 35 years, lordosis angle more than 35 degrees, not having any history of fracture and surgery in the spine, not having a pathological history of spine disease, orthopedic injuries and joint diseases in the spine, back pain greater than 3 according to the visual pain scale, history Back pain for at least three months
Intervention groups
The first intervention group performs the Egoscue exercises along with abdominal draw-in maneuvers for eight weeks.
The second intervention group performs NASM exercises along with abdominal draw-in maneuvers for eight weeks.
The control group will have their usual routine during this time.
Main outcome variables
Back pain; Lumbar lordosis angle; Disability; Quality of life; Pain self-efficacy; Kinesiophobia; Body awareness; Muscle endurance; Balance, Postural sway; Gait.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N11
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Egoscue and NASM exercises with abdominal draw-in maneuver on pain and lumbar lordotic angle in women with chronic back pain
Public title
Exercise therapy and chronic back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Lordosis angle upper 35 degree
Not having any history of fracture and surgery in the spine
Not having a history of pathology, orthopedic injuries and joint diseases in the spine
Back pain level greater than 3 according to the visual analogue scale
Exclusion criteria:
Reluctance to participate in exercises
Suffering from other spinal deformities
Severe visual impairment or vestibular problems
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
10 cards, marked "A" for Egoscue, 10 cards marked "B" for NASM, and another 10 cards, marked "C" for the control group, will be placed in an opaque envelope. Each participant draws a card that represents the group for that person. A researcher who is not involved in the interventions will divide the participants into random groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher that does laboratory tests was not aware of the allocation of study groups.
The data analyzer will not be aware of the group's classification. The information about the groups will be provided to the data analyzer in the form of numbers 1, 2, and 3 and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.ARAKU.REC.1402.007
Health conditions studied
1
Description of health condition studied
Chronic Non-Specific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
2
Description of health condition studied
Lordosis
ICD-10 code
M40.46
ICD-10 code description
Postural lordosis, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
First week, fourth week, eighth week
Method of measurement
Visual Analogue Scale and McGill questionnaire
2
Description
Lumbar lordosis angle
Timepoint
First week, fourth week, eighth week
Method of measurement
Spinal mouse
3
Description
Disability
Timepoint
First week, fourth week, eighth week
Method of measurement
Roland morris questionnaire
4
Description
Quality of life
Timepoint
First week, fourth week, eighth week
Method of measurement
SF-36 Questionnaire
5
Description
Muscular strength
Timepoint
First week, fourth week, eighth week
Method of measurement
The modified Biering-Sorensen test
Secondary outcomes
1
Description
Postural sway
Timepoint
First week, fourth week, eighth week
Method of measurement
Pedoscan
2
Description
Gait
Timepoint
First week, fourth week, eighth week
Method of measurement
Pedoscan
3
Description
Kinesiophobia
Timepoint
First week, fourth week, eighth week
Method of measurement
Tampa scale
4
Description
Body awareness
Timepoint
First week, fourth week, eighth week
Method of measurement
Body awareness questionnaire
5
Description
Spine range of motion
Timepoint
First week, fourth week, eighth week
Method of measurement
Spinal mouse
Intervention groups
1
Description
Intervention group: The Egoscue group will perform the Egoscue exercises along with the Abdominal Drawing-in Maneuver for eight weeks and three sessions per week. Egoscue exercises stretch and strengthen the muscles in order to correct the position of the spine and pelvis. These corrective exercises are designed with a focus on correcting the posture of the entire body. Abdominal Drawing-in Maneuver (ADIM) is a method that is often used to voluntarily activate the muscles of the abdominal area and eliminate the functional disorder of these muscles.
Category
Rehabilitation
2
Description
Intervention group: NASM exercises include 4 stages: Inhibitory technique, Muscle lengthening techniques, Activation technique, and Coherence techniques. This group will do exercises along with the Abdominal Drawing-in Maneuver for eight weeks and three sessions a week.
Category
Rehabilitation
3
Description
Control group: During the whole period of eight weeks, the control group will have their usual routine of life.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Hamed Safikhani
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university
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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@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
Not applicable
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