Effectiveness of the resistance exercises with motor skills training and pain reprocessing program on pain, performance, and quality of life in flight attendants with chronic non-specific low back pain
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Protocol summary
مقایسه تأثیر تمرینات مقاومتی با آموزش مهارت های حرکتی و پردازش مجدد درد بر درد، عملکرد و کیفیت زندگی مهمانداران هواپیما دارای کمردرد مزمن غیراختصاصی
مقایسه تأثیر تمرینات مقاومتی با آموزش مهارت های حرکتی و پردازش مجدد درد بر درد، عملکرد و کیفیت زندگی مهمانداران هواپیما دارای کمردرد مزمن غیر اختصاصی
مقایسه تأثیر تمرینات مقاومتی با آموزش مهارت های حرکتی و پردازش مجدد درد بر درد، عملکرد و کیفیت زندگی مهمانداران هواپیما دارای کمردرد مزمن غیراختصاصیغیر اختصاصی
مهمانداران هواپیما دارای کمردرد مزمن غیراختصاصی که در طول مطالعه به مرکز تندرستی و سلامت دانشگاه خوارزمی مراجعه کنند در صورت واجد شرایط بودن وارد مطالعه خواهند شد و به صورت تصادفی به روش بلوکهای تصادفی به گروههای مداخله و کنترل تخصیص داده خواهند. این مطالعه به صورت یک سو کور اجرا خواهد شد به نحوی که پزشک معاینه کننده از نوع مداخله ها اطلاعی نخواهد داشت.
مهمانداران هواپیما دارای کمردرد مزمن غیر اختصاصی که در طول مطالعه به مرکز تندرستی و سلامت دانشگاه خوارزمی مراجعه کنند در صورت واجد شرایط بودن وارد مطالعه خواهند شد و به صورت تصادفی به روش بلوکهای تصادفی به گروههای مداخله و کنترل تخصیص داده خواهند. این مطالعه به صورت یک سو کور اجرا خواهد شد به نحوی که پزشک معاینه کننده از نوع مداخله ها اطلاعی نخواهد داشت.
مهمانداران هواپیما دارای کمردرد مزمن غیراختصاصیغیر اختصاصی که در طول مطالعه به مرکز تندرستی و سلامت دانشگاه خوارزمی مراجعه کنند در صورت واجد شرایط بودن وارد مطالعه خواهند شد و به صورت تصادفی به روش بلوکهای تصادفی به گروههای مداخله و کنترل تخصیص داده خواهند. این مطالعه به صورت یک سو کور اجرا خواهد شد به نحوی که پزشک معاینه کننده از نوع مداخله ها اطلاعی نخواهد داشت.
درد، عملکرد، کیفیت زندگی، ناتوانی، ترس از حرکت، درد فاجعه‌بار درد، باورهای اجتناب از ترس، خودکارآمدی درد، افسردگی، اضطراب، استرس
درد، عملکرد، کیفیت زندگی، ناتوانی، ترس از حرکت، درد فاجعه‌بار درد، باورهای اجتناب از ترس، خودکارآمدی درد، افسردگی، اضطراب، استرس
General information
2022-09-01, 1401/06/10
2023-12-24, 1402/10/03
20222023-0912-0124 00:00:00
2022-10-02, 1401/07/10
2024-01-22, 1402/11/02
20222024-1001-0222 00:00:00
empty
Dear all
in order to the fact that the patients collection was not carried out at the specified time due to the large number of patients, the current research needs to change the time of the patient collection.
Dear all in order to the fact that the patients collection was not carried out at the specified time due to the large number of patients, the current research needs to change the time of the patient collection.
empty
با سلام
با توجه به محقق نشدن پروسه بیمارگیری به دلیل تعداد زیاد بیماران، تحقیق حاضر نیاز به تغییر تاریخ بیمارگیری دارد.
با تشکر
با سلام با توجه به محقق نشدن پروسه بیمارگیری به دلیل تعداد زیاد بیماران، تحقیق حاضر نیاز به تغییر تاریخ بیمارگیری دارد. با تشکر
Primary outcomes
#1
pain
Pain
painPain
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
Secondary outcomes
#1
disability
Disability
disabilityDisability
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#2
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#3
catastrophizing Pain
Catastrophizing Pain
catastrophizingCatastrophizing Pain
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#4
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#5
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#6
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#7
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#8
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#9
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#10
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#11
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#12
anxiety
Anxiety
anxietyAnxiety
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
#13
before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
beforeBefore intervention, after 8 weeks of intervention, and after 3 months of follow-up
Recruitment centers
#1
Name of recruitment center - English: Kharazmi University Health Center
Name of recruitment center - Persian: مرکز سلامت دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Street address - English: Karaj - Hesarak - University Square - Kharazmi University
Street address - Persian: کرج – حصارک- میدان دانشگاه- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Fax:
Email: zolfagharinegin1992@gmail.com
Web page address:
Name of recruitment center - English: Kharazmi University Health Center
Name of recruitment center - Persian: مرکز سلامت دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak. Karaj
Street address - Persian: کرج – حصارک- بلوار بهشتی- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Fax:
Email: zolfagharinegin1992@gmail.com
Web page address:
Name of recruitment center - English: Kharazmi University Health Center Name of recruitment center - Persian: مرکز سلامت دانشگاه خوارزمی Full name of responsible person - English: Negin Zolfaghari Full name of responsible person - Persian: نگین ذوالفقاری Street address - English: Karaj - Hesarak - University Square - Kharazmi University, Beheshti Blvd, Hesarak. Karaj Street address - Persian: کرج – حصارک- میدان دانشگاهبلوار بهشتی- دانشگاه خوارزمی City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 37551-31979 Phone: +98 903 320 2456 Fax: Email: zolfagharinegin1992@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Street address - English: Karaj - Hesarak - University Square - Kharazmi University
Street address - Persian: کرج – حصارک- میدان دانشگاه- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Fax:
Email: zZolfagharinegin1992@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Mohammad Delnavaz
Full name of responsible person - Persian: محمد دلنواز
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: کرج – حصارک- بلوار بهشتی- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 26 3457 5017
Fax:
Email: research@khu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kharazmi University Name of organization / entity - Persian: دانشگاه خوارزمی Full name of responsible person - English: Negin ZolfaghariMohammad Delnavaz Full name of responsible person - Persian: نگین ذوالفقاریمحمد دلنواز Street address - English: Karaj - Hesarak - University Square - Kharazmi University, Beheshti Blvd, Hesarak, Karaj Street address - Persian: کرج – حصارک- میدان دانشگاهبلوار بهشتی- دانشگاه خوارزمی City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 37551-31979 Phone: +98 903 320 245626 3457 5017 Fax: Email: zZolfagharinegin1992research@gmail.comkhu.ac.ir Web page address:
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک- بلوار بهشتی- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک، بلوار بهشتی، دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kharazmi University Name of organization / entity - Persian: دانشگاه خوارزمی Full name of responsible person - English: Negin Zolfaghari Full name of responsible person - Persian: نگین ذوالفقاری Position - English: Student Position - Persian: دانشجو Latest degree: master Area of specialty/work: 88 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj Street address - Persian: حصارک-، بلوار بهشتی-، دانشگاه خوارزمی City - English: Karaj City - Persian: کرج Province: Alborz Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 37551-31979 Phone: +98 903 320 2456 Mobile: +98 903 320 2456 Fax: Email: Zolfagharinegin1992@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشکاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک- بلوار بهشتی- دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشکاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک، بلوار بهشتی، دانشگاه خوارزمی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kharazmi University Name of organization / entity - Persian: دانشکاه خوارزمی Full name of responsible person - English: Negin Zolfaghari Full name of responsible person - Persian: نگین ذوالفقاری Position - English: studentStudent Position - Persian: دانشجو Latest degree: master Area of specialty/work: 88 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj Street address - Persian: حصارک-، بلوار بهشتی-، دانشگاه خوارزمی City - English: Karaj City - Persian: کرج Province: Alborz Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 37551-31979 Phone: +98 903 320 2456 Mobile: +98 903 320 2456 Fax: Email: Zolfagharinegin1992@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: studnet
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک- بلوار بهشتی- دانشگاه خوارزمی
City - English: Kraj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Negin Zolfaghari
Full name of responsible person - Persian: نگین ذوالفقاری
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj
Street address - Persian: حصارک، بلوار بهشتی، دانشگاه خوارزمی
City - English: Kraj
City - Persian: کرج
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 37551-31979
Phone: +98 903 320 2456
Mobile: +98 903 320 2456
Fax:
Email: Zolfagharinegin1992@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kharazmi University Name of organization / entity - Persian: دانشگاه خوارزمی Full name of responsible person - English: neginNegin Zolfaghari Full name of responsible person - Persian: نگین ذوالفقاری Position - English: studnetStudent Position - Persian: دانشجو Latest degree: master Area of specialty/work: 88 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Kharazmi University, Beheshti Blvd, Hesarak, Karaj Street address - Persian: حصارک-، بلوار بهشتی-، دانشگاه خوارزمی City - English: Kraj City - Persian: کرج Province: Alborz Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 37551-31979 Phone: +98 903 320 2456 Mobile: +98 903 320 2456 Fax: Email: Zolfagharinegin1992@gmail.com Web page address:
Protocol summary
Study aim
Comparison of the effect of resistance training with motor skills training and pain reprocessing on pain, performance and quality of life of flight attendants with non-specific chronic back pain
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 60 patients.
Settings and conduct
Flight attendants with non-specific chronic low back pain who refer to the health and wellness center of Kharazmi University during the study, if they are eligible, will be included in the study and will be randomly assigned to the intervention and control groups using a randomized block method. This study is conducted in a single-blinded manner so that the doctor examining the patients does not know about the type of interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female flight attendants with non-specific chronic low back pain between 20 and 40 years old;
Exclusion criteria: history of any surgery and inflammatory diseases in the spine area, history of any musculoskeletal abnormalities in the spine area
Intervention groups
Intervention group 1: resistance exercises along with motor skill exercises (24 sessions over 8 weeks)
Intervention group 2: resistance exercises with pain reprocessing (8 sessions over 4 weeks)
Intervention group 3: resistance exercises with motor skill exercises and pain reprocessing (24 sessions over 8 weeks combined with 8 sessions of pain reprocessing over 4 weeks)
Control group:only resistance training (24 sessions over 8 weeks)
Main outcome variables
Pain, performance, quality of life, disability, fear of movement, pain catastrophizing, fear-avoidance beliefs, pain self-efficacy, depression, anxiety, stress.
General information
Reason for update
Dear all
in order to the fact that the patients collection was not carried out at the specified time due to the large number of patients, the current research needs to change the time of the patient collection.
Acronym
IRCT registration information
IRCT registration number:IRCT20220804055617N1
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2023-11-27, 1402/09/06
Update count:2
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Negin Zolfaghari
Name of organization / entity
Kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 2651 1379
Email address
zolfagharinegin1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-24, 1402/10/03
Expected recruitment end date
2024-01-22, 1402/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the resistance exercises with motor skills training and pain reprocessing program on pain, performance, and quality of life in flight attendants with chronic non-specific low back pain
Public title
The effect of a psychological-movement-based intervention in individuals with non-specific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female flight attendants with non-specific chronic back pain
Male and female flight attendants with an age range of 20-40 years
Exclusion criteria:
History of any surgery and inflammatory diseases in the spine area
History of any musculoskeletal abnormalities in the spine area
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using random permuted blocks randomization (16 blocks with size 8), four treatment combinations are independently allocated to participants by1:1:1:1 ratio (after the initial assessment). The random sequence list was generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983), and using (https://www.randomizer.org) This step will be guaranteed by a blind assessor.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blind to group allocation. Participants will not be blind to the study and grouping; however, they were not aware which treatment will be considered as therapeutic (There is an unavoidable risk of bias in this study where the intervention cannot be blinded to interventionists, patients). Before the evaluation, the necessary training will be given to the outcome assessor in relation to how to measure the outcomes in order to prevent any questions and answers between the assessor and the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
No 3 - Fifth Alley- Mir Emad St. - Ostad Motahari St. Tehran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-07-20, 1401/04/29
Ethics committee reference number
IR.SSRC.REC.1401.048
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
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Disability
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Roland Morris disability questionnaire
2
Description
Kinesiophobia
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Tempa Scale Of Kinesiphobia
3
Description
Catastrophizing Pain
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Pain catastrophizing scale
4
Description
Fear avoidance beliefs
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Fear avoidance beliefs questionnaire
5
Description
Pain self-efficacy
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Pain self-efficacy questionnaire
6
Description
Depression
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
DASS questionnaire
7
Description
Quality of life
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
The 36-Item quality of life questionnaire
8
Description
Performance
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Finger to floor test
9
Description
Single Limb Stance
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Single Limb Stance test
10
Description
Sitting On Bobath Ball
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
Sitting On Bobath Ball test
11
Description
Muscular Endurance
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
McGill's Torso Muscular Endurance Test Battery
12
Description
Anxiety
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
DASS questionnaire
13
Description
Stress
Timepoint
Before intervention, after 8 weeks of intervention, and after 3 months of follow-up
Method of measurement
DASS questionnaire
Intervention groups
1
Description
First intervention group: people receive resistance exercises along with motor skill exercises. Resistance exercises: It includes exercises for the muscles of the trunk area, which is divided into 3 stages, each stage is gradually more difficult. All patients will begin with Phase 1 exercises. Training will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Motor skills training: will include motor skills training and challenging functional activities that are difficult to perform due to back pain.
Category
Rehabilitation
2
Description
In the second intervention group: participants receive resistance exercises with pain reprocessing. Resistance exercises: include exercises for the muscles of the trunk area, which are divided into 3 phases, each phase is gradually more difficult. All patients will begin with Phase 1 exercises. Exercises will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Pain reprocessing: involves education aimed at increasing patients' re-perception of primary chronic pain as a false alarm generated by the brain. Pain reprocessing shares concepts and techniques with existing treatments for pain and cognitive behavioral therapy for the fear disorder. Participants will complete 8 sessions of 1-hour individual therapy sessions with an experienced therapist twice weekly for 4 weeks. Techniques include (1) providing personal evidence for focused pain (2) guided reappraisal of pain sensation while sitting and while engaging in fearful situations or movements (3) techniques focusing on psychosocial factors (e.g, depression) that potentially increase pain, and (4) techniques to increase positive emotions and self-compassion.
Category
Rehabilitation
3
Description
In the third intervention group: participants receive resistance exercises with motor skill exercises and pain reprocessing. Resistance exercises: include exercises for the muscles of the trunk area, which are divided into 3 phases, each phase is gradually more difficult. All patients will begin with Phase 1 exercises. Exercises will be done three days a week and for eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week. Motor skills training: will include motor skills education and challenging functional activities that are difficult to perform due to low back pain. Pain reprocessing: involves education aimed at increasing patients' re-perception of primary chronic pain as a false alarm generated by the brain. Pain reprocessing shares concepts and techniques with existing treatments for pain and cognitive behavioral therapy for the fear disorder. Participants will complete 8 sessions of 1-hour individual therapy sessions with an experienced therapist twice weekly for 4 weeks. Techniques include (1) providing personal evidence for focused pain (2) guided reappraisal of pain sensation while sitting and while engaging in fearful situations or movements (3) techniques focusing on psychosocial factors (e.g, depression) that potentially increase pain, and (4) techniques to increase positive emotions and self-compassion.
Category
Rehabilitation
4
Description
Control group: Individuals will only receive resistance training. Resistance exercises: includes exercises for the muscles of the trunk area, which is divided into 3 stages, each stage is gradually more difficult. All patients will begin with Phase 1 exercises. Training will be done three days a week and in eight weeks. 2-3 sets of 8-10 repetitions are performed 2-3 times a week.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only data related to demographic and outcomes information is shared.
When the data will become available and for how long
After publishing the article/articles extracted from the study
To whom data/document is available
Data upon reasonable request of the Clinical Trial Registry
Iran, journals and people/university researchers who are in this field
Research and scientific activities can be displayed and shared
Under which criteria data/document could be used
Data analysis and use of documents can only be done provided that their results are reported in scientific articles conducted by researchers and academic researchers. Necessary conditions for sending data and documents include 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation of how to use the data or documents.
From where data/document is obtainable
Through requesting from Amir Letafatkar
letafatkaramir@yahoo.com
What processes are involved for a request to access data/document
The applicant can request details from the researchers within 7 to 14 days using the message sent by email.