The effect of adding hamstring stretching exercises to core stability exercises on pain, range of motion, sense of position, fear of movement and function of pre-elderly women with non-specific chronic back pain
The effect of adding hamstring stretching exercises to core stability exercises on pain, range of motion, sense of position, fear of movement and function of pre-elderly women with non-specific chronic back pain
Design
Clinical trial with control group with parallel groups, single blinded, randomized, on 30 patients.
Settings and conduct
The location of the study will be Dr. Shakri's pain clinic in Zahedan city. The study population will be selected from those who refer to this clinic with chronic non-specific back pain problems. After the tests, they will be divided into intervention and control groups according to the entry and exit criteria. The study will be single blind, so that the samples will not know the details of the tests and exercise groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being female, suffering from non-specific chronic back pain; age range 48 to 58 years; suffering from hamstring shortness.
Exclusion criteria: Receiving treatment related to non-specific chronic back pain in the last month; Back pain caused by a fracture or protrusion of a lumbar disc; Diseases that affect the research process; Cardiovascular diseases or diabetes; Cancer; Osteoporosis; Surgery in the lower limbs, abdomen or chest and spine; Back pain caused by trauma; Accompanying structural changes in the tissues of the back or hamstring muscles.
Intervention groups
Intervention group: core stability exercises and hamstring stretching exercises;
Control group: core stability exercises
Main outcome variables
Pain, range of motion, impaired sense of position, fear of movement; performance weakness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250113064372N1
Registration date:2025-02-24, 1403/12/06
Registration timing:prospective
Last update:2025-02-24, 1403/12/06
Update count:0
Registration date
2025-02-24, 1403/12/06
Registrant information
Name
Asma Eshaghi
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 6251
Email address
asal.es7501@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-28, 1403/12/10
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding hamstring stretching exercises to core stability exercises on pain, range of motion, sense of position, fear of movement and function of pre-elderly women with non-specific chronic back pain
Public title
Hamstring stretching exercises and core stability exercises in back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with non-specific chronic back pain
Being at the age of 48 - 58 years
Hamstring contracture
Exclusion criteria:
Receiving treatment related to non-specific chronic back pain in the last month
Back pain caused by a fracture or protrusion of a lumbar disc
Diseases that affect the research process
Cardiovascular diseases or diabetes
Cancer
Osteoporosis
Surgery in the lower limbs, abdomen or chest and spine
Back pain caused by trauma
Accompanying structural changes in the tissues of the back or hamstring muscles
Age
From 48 years old to 58 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Through a drawing a piece of paper and in the presence of the people themselves, each person will be given a number from 1 to 30. The numbers will be written on paper, folded and placed in a container (container number 1). Then, in another container, the names of the groups (15 sheets per group) will be folded and placed inside the container (container number 2).
Then, the "drawing a piece of paper" process will be done in the presence of the participants. One person will draw the number and group and one person will do this to record and write the numbers. All people will be grouped in the same way.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants participate in the study with the assumption that they will receive a similar exercise.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Sistan and Baluchistan University
Street address
Dasneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745785
Approval date
2024-11-09, 1403/08/19
Ethics committee reference number
IR.USB.REC.1403.031
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 level
Timepoint
Before the start of the intervention, one day after the end of the intervention
Method of measurement
Visual Analogue Pain Scale,
2
Description
Range of motion
Timepoint
Before the start of the intervention, one day after the end of the intervention
Method of measurement
sorensen test,
3
Description
Sense of situation
Timepoint
Before the start of the intervention, one day after the end of the intervention
Method of measurement
repositioning error
4
Description
Fear of movement
Timepoint
Before the start of the intervention, one day after the end of the intervention
Method of measurement
Five times sit to stand test
5
Description
Performance
Timepoint
Before the start of the intervention, one day after the end of the intervention
Method of measurement
Roland‐Morris Disability Questionnaire, oswestry disability index ،
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: core stability exercises and hamstring stretching exercises to increase the flexibility of this muscle. Exercises will be performed three times a week for 8 weeks
Category
Rehabilitation
2
Description
Control group: core stability exercises ,three times a week for 8 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Shakeri pain clinic
Full name of responsible person
Asadollah Shakeri
Street address
Khayam street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816847154
Phone
+98 992 190 2556
Email
drashakeri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sistan and Baluchestan University of Medical Sciences
Full name of responsible person
Noor Mohammad Yaghoobi
Street address
Daneshgah street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-45845
Phone
+98 54 3113 6245
Email
yaghoubi@mgmt.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sistan and Baluchestan University of Medical Sciences
Proportion provided by this source
20
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
Sistan and Baluchestan University of Medical Sciences
Full name of responsible person
Asma Eshaghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Corrective exercise
Street address
Daneshgah street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745785
Phone
+98 54 3113 2000
Email
asal.es7501@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sistan and Baluchestan University of Medical Sciences
Full name of responsible person
Asma Eshaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport pathology and corrective exercises
Street address
Daneshgah street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۵۸۴۵
Phone
+98 54 3344 6251
Fax
Email
asal.es7501@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sistan and Baluchestan University of Medical Sciences
Full name of responsible person
Asma Eshaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport pathology and corrective exercises
Street address
Daneshgah street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۵۸۴۵
Phone
+98 54 3344 6251
Fax
Email
asal.es7501@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