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Effects of a combined exercise intervention program with cognitive physical therapy on pain, disability and postural sway on women with chronic non-specific low back pain

Protocol summary

Study aim
Effects of a combined exercise intervention program with cognitive physical therapy on pain, disability and postural sway on women with chronic non-specific low back pain
Design
Randomized, clinical trial with control group , single blinded
Settings and conduct
The present study will be conducted in Arak city. 45 women with non-specific chronic back pain will participate in this study in the form of three groups of combined exercises, combined exercises with cognitive functional therapy and control. The exercises will be done for eight weeks and three sessions in each week.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include suffering from non-specific chronic back pain (with a history of pain for at least 3 months) as diagnosed by a specialist doctor, not suffering from cardiorespiratory diseases, neuromuscular diseases and diabetes, not having a history of surgery, fractures, serious injuries in The spine includes disc herniation, no obvious structural abnormalities in the spine, not having a difference in the length of the legs, a disability score equal to or greater than 4 in the Roland Morris Disability Questionnaire, and a score of at least 3 on the visual pain measurement scale. Also, if the subjects do not participate regularly in the training sessions (two consecutive sessions and three non-consecutive sessions), they will be excluded from the study.
Intervention groups
Combined exercises that include aerobic, resistance, flexibility and strength exercises. Combined exercises with cognitive function therapy. Combined exercises that include aerobic, resistance, flexibility and strength exercises and cognitive function therapy target physical, lifestyle and psychological barriers to recovery. The control group will have the usual routine of life.
Main outcome variables
Pain, Disability, Postural sway, Kinesiophobia, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220722055522N1
Registration date: 2022-12-03, 1401/09/12
Registration timing: prospective

Last update: 2022-12-03, 1401/09/12
Update count: 0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Mahsa Asgari
Name of organization / entity
The university of arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3224 1517
Email address
mahsa.as13701370@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a combined exercise intervention program with cognitive physical therapy on pain, disability and postural sway on women with chronic non-specific low back pain
Public title
Effects of a combined exercise intervention program with cognitive physical therapy on women with chronic non-specific low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from non-specific chronic back pain (with a history of pain for at least 3 months) Absence of cardiorespiratory diseases Absence of neuromuscular diseases Not having diabetes No history of surgery No history of fracture Not having a history of serious injuries in the spine, including disc herniation Not having obvious structural abnormalities in the spine No difference in leg length Obtaining a disability score equal to or greater than 4 in the Roland Morris Disability Questionnaire Obtaining a score of at least 3 from the visual pain measurement scale
Exclusion criteria:
Having neuropathic pain, history of previous lumbar spine surgery history of previous lumbar spine surgery Mental disability Severe mental illness Illiteracy If the subjects do not regularly participate in the training sessions (two consecutive sessions and three non-consecutive sessions), they will be excluded from the study.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
In this semi-experimental research, the sample size was calculated using Gpower software for the effect size (0.5), test power (0.8) and significance level (0.05) of 42 people and 14 people in each group. Considering the possibility of dropping out in the groups, 45 women with non-specific chronic back pain (n=15) will participate in this study voluntarily according to the inclusion and exclusion criteria. The subjects will be divided into three groups randomly using the Randlist software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not have information about the grouping of the subjects and the data of the groups will be provided to her in the form of codes (1, 2 and 3).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University
Street address
Arak University, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.ARAKU.REC.1401.020

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Pain
Timepoint
Before and after intervention
Method of measurement
The visual analogue scale

2

Description
Disability
Timepoint
Before and after intervention
Method of measurement
The roland-morris disability questionnaire

Secondary outcomes

1

Description
Postural sway
Timepoint
Before and after intervention
Method of measurement
Foor scan

2

Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
SF-36questionnaire

3

Description
Kinesiophobia
Timepoint
Before and after intervention
Method of measurement
Kinesiophobia questionnaire

4

Description
The balance
Timepoint
Before and after intervention
Method of measurement
Y balance test

5

Description
walking
Timepoint
Before and after intervention
Method of measurement
Foot scan

6

Description
Muscular endurance
Timepoint
Before and after intervention
Method of measurement
Sorensen's test

Intervention groups

1

Description
Intervention group 1: Performing combined exercises that include eight weeks of aerobic, endurance, strength, and flexibility exercises.
Category
Rehabilitation

2

Description
Intervention group 2: Conducting eight weeks of combined exercises with cognitive function therapy. The combined exercises that include aerobic, endurance, strength, and flexibility exercises. The cognitive function therapy targets lifestyle modification and psychological factors to help patients with chronic low back pain. The goals of this approach are to reconceptualize pain from a biopsychosocial perspective while eliminating unhelpful beliefs, overcoming barriers to functional participation related to relevant personal goals, and adopting a healthy lifestyle.
Category
Rehabilitation

3

Description
Control group: They 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 3262 9024
Email
z-raeisi@araku.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Hamed Safikhani
Street address
Arak University, Basij square, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3814947195
Phone
+98 86 3224 1517
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, Basij square, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Email
Z_raisi13@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Basij Square, 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, Basij square, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3814947195
Phone
+98 86 3224 1517
Email
z-raeisi@araku.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Mahsa Asgari
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ordibehesht Alley, Dr hesabi Street, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3814947195
Phone
+98 86 3224 1517
Email
mahsa.as13701370@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
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
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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