The effect of pilates exercises with cognitive functional therapy on pain, quality of life, lordosis angle, and posture fluctuation in women with non-specific chronic low back pain
The aim of this study was to determine the effect of selected Pilates exercises, along with functional cognitive therapy, on pain, quality of life, lordosis angle, and postural sway in women with non-specific chronic low back pain.
Design
A randomized clinical trial, single-blinded, three-arm parallel-group, phase 3 with 120 patients. The Random.org site will be used for randomization.
Settings and conduct
This study will be conducted in the sports rehabilitation laboratory of Arak University.
Participants/Inclusion and exclusion criteria
The participants will be women with an age range of 30 to 50 years and suffering from non-specific chronic back pain and lumbar hyperlordosis. If the participants have severe deformities apart from hyperlordosis, a history of surgery, or a fracture in the spine, they will not be included in the study.
Intervention groups
The study will have three groups. The first intervention group will do Pilates exercises. The second intervention group will receive Pilates exercises along with cognitive functional therapy. The third group is the control group, who will have their usual life routine.
Main outcome variables
The pain; Quality of life; Lordosis angle; Postural sway
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N14
Registration date:2024-04-18, 1403/01/30
Registration timing:prospective
Last update:2024-04-18, 1403/01/30
Update count:0
Registration date
2024-04-18, 1403/01/30
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
2024-04-24, 1403/02/05
Expected recruitment end date
2024-06-25, 1403/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pilates exercises with cognitive functional therapy on pain, quality of life, lordosis angle, and posture fluctuation in women with non-specific chronic low back pain
Public title
The effect of pilates exercises and cognitive functional therapy on chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged between 30 and 50 years
A history of non-specific chronic low back pain for at least three months
Having lumbar hyperlordosis
Not having a history of heart problems, stroke
Back pain level greater than 3 according to the visual analogue scale
Exclusion criteria:
Having other deformities in the spine
History of serious spine injury
Reluctance to participate in exercises
Age
From 30 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using Random.org. On this site, the Sequence option is selected from the Numbers tab. The smallest value is 1, and the largest value is 120. Considering that the present study will have three groups, the format will be in three columns. Then, the sequence option is selected. After that, the site randomly places each number in one of the three columns. Each column represents a group, and forty numbers are placed in each group. Finally, each participant is placed in one of three groups according to their number.
Blinding (investigator's opinion)
Single blinded
Blinding description
Firstly, the purpose of the research will be explained to the participants. This research aims to determine the effect of Pilates exercises on lumbar lordosis and back pain. After that, the participants will receive group-specific explanations about the intervention that they will receive during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bu-ali sina university ethics committee in research
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.BASU.REC.1402.094
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
Primary outcomes
1
Description
Pain
Timepoint
First and eighth week
Method of measurement
quebec back pain questionnaire, Visual analoge scale
2
Description
Quality of life
Timepoint
First and eighth week
Method of measurement
36-Item Short Form Survey Instrument (SF-36)
3
Description
Lumbar lordosis angle
Timepoint
First and eighth week
Method of measurement
DIERS formetric 4D (Rasterstereography)
4
Description
Postural sway
Timepoint
First and eighth week
Method of measurement
DIERS formetric 4D
Secondary outcomes
1
Description
Disability
Timepoint
First and eighth week
Method of measurement
Oswestry disability index
2
Description
Gait
Timepoint
First and eighth week
Method of measurement
Pedoscan
3
Description
kinesiophobia
Timepoint
First and eighth week
Method of measurement
Tampa questionnaire
4
Description
Muscular endurance
Timepoint
First and eighth week
Method of measurement
McGill and biering-sorensen tests
Intervention groups
1
Description
Intervention grou 1: Pilates exercises. Participants in this group will perform selected Pilates exercises for eight weeks and three sessions per week with focusing on core muscle and reducing the lumbar lordosis angle.
Category
Other
2
Description
Intervention group 2: Pilates exercise and functional cognitive therapy. This group performs Pilates exercises the same as the intervention 1 group. But they do cognitive functional therapy along with Pilates exercises. In cognitive functional therapy, different movements and movement patterns are attempted to help the patient move without pain, fear, muscle guarding, and limiting motions.
Category
Other
3
Description
Control group: The control group will have their usual life routine.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Shariati street
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
Bu Ali-Sina University
Full name of responsible person
Arash Ghorbani
Street address
Vice Chancellery For Research Affairs, Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1601
Email
sakhai@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali-Sina 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
Basij Square, Arak University
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
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@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
Basij Square, Arak University
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to the main outcomes can be shared.
When the data will become available and for how long
One year after the results are published.
To whom data/document is available
Academic researchers who intend to write meta-analysis articles.
Under which criteria data/document could be used
Data use is allowed only for meta-analysis articles.
From where data/document is obtainable
The corresponding author of the article will respond via email.
What processes are involved for a request to access data/document
Researchers who request data provide their explanations in an email to the corresponding author. After checking, if approved, the data will be sent to the researcher within a week.