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Protocol summary
A sample population of 105 subjects was purposefully selected using G-power statistical software. The volunteers are then equally divided into 3 groups (control group, patient-led goal setting group with pain neuroscience education and patient-led goal setting group with manual therapy).
A sample population of 45 subjects was purposefully selected using G-power statistical software. The volunteers are then equally divided into 3 groups (control group, patient-led goal setting group with pain neuroscience education and patient-led goal setting group with manual therapy).
A sample population of 10545 subjects was purposefully selected using G-power statistical software. The volunteers are then equally divided into 3 groups (control group, patient-led goal setting group with pain neuroscience education and patient-led goal setting group with manual therapy).
از میان جامعه اماری تعداد 105 آزمودنی با نرمافزار آماری جی-پاور به صورت هدفمند انتخاب میشوند که داوطلبان متشکل از 3 گروه 35 نفره (گروه کنترل، گروه هدف گذاری با رهبری بیمار همراه با اموزش علوم اعصاب درد و گروه هدف گذاری با رهبری بیمار همراه با درمان دستی ) در این تحقیق حضور مییابند.
از میان جامعه اماری تعداد 45 آزمودنی با نرمافزار آماری جی-پاور به صورت هدفمند انتخاب میشوند که داوطلبان متشکل از 3 گروه 15 نفره (گروه کنترل، گروه هدف گذاری با رهبری بیمار همراه با اموزش علوم اعصاب درد و گروه هدف گذاری با رهبری بیمار همراه با درمان دستی ) در این تحقیق حضور مییابند.
از میان جامعه اماری تعداد 10545 آزمودنی با نرمافزار آماری جی-پاور به صورت هدفمند انتخاب میشوند که داوطلبان متشکل از 3 گروه 3515 نفره (گروه کنترل، گروه هدف گذاری با رهبری بیمار همراه با اموزش علوم اعصاب درد و گروه هدف گذاری با رهبری بیمار همراه با درمان دستی ) در این تحقیق حضور مییابند.
Targeted individuals are randomly assigned to 3 groups of 35 people. Initially, the Start Back questionnaire will be used to evaluate and classify patients suffering from nonspecific chronic low back pain. Additionally, appropriate questionnaires will be used to assess pain intensity, disability, quality of life, depression / anxiety and stress, kinesiophobia, pain self-efficacy, and catastrophic pain, neurophysiology of pain, beliefs about fear avoidance and the presence of central sensitivity. Accordingly, these variables will be measured 2, 4, and 12 months after the conclusion of the intervention.interventions will be performed in Kharazmi University Health Centre.
Targeted individuals are randomly assigned to 3 groups of 15 people. Initially, the Start Back questionnaire will be used to evaluate and classify patients suffering from nonspecific chronic low back pain. Additionally, appropriate questionnaires will be used to assess pain intensity, disability, quality of life, depression / anxiety and stress, kinesiophobia, pain self-efficacy, and catastrophic pain, neurophysiology of pain, beliefs about fear avoidance and the presence of central sensitivity. Accordingly, these variables will be measured 2, 4, and 12 months after the conclusion of the intervention.interventions will be performed in Kharazmi University Health Centre.
Targeted individuals are randomly assigned to 3 groups of 3515 people. Initially, the Start Back questionnaire will be used to evaluate and classify patients suffering from nonspecific chronic low back pain. Additionally, appropriate questionnaires will be used to assess pain intensity, disability, quality of life, depression / anxiety and stress, kinesiophobia, pain self-efficacy, and catastrophic pain, neurophysiology of pain, beliefs about fear avoidance and the presence of central sensitivity. Accordingly, these variables will be measured 2, 4, and 12 months after the conclusion of the intervention.interventions will be performed in Kharazmi University Health Centre.
افراد هدفدار به صورت تصادقی به سه گروه 35 نفره تقسیم میشوند. در ابتدا به تمامی اعضای گروهها پرسشنامه Start Back جهت ارزیابی و تقسیم بندی بیماران مبتلا به کمردرد مزمن غیراختصاصی استفاده خواهد شد و همچنین برای ارزیابی شدت درد، ناتوانی، کیفیت زندگی، افسردگی/اضطراب و استرس ، کینزوفوبیا، خودکارامدی درد، فاجعه بار کردن درد، نوروفیزیولوژی درد، باورهای اجتناب از ترس و وجود حساسیت مرکزی از پرسشنامههای مربوطه استفاده میشود و به همین ترتیب 2 ماه پس از درمان 4 و 12 ماه پس از پایان مداخلات هر بار این متغییرها اندازهگیری میشوند. مداخلات در مرکز سلامت دانشگاه خوارزمی انجام خواهد شد.
افراد هدفدار به صورت تصادقی به سه گروه 15 نفره تقسیم میشوند. در ابتدا به تمامی اعضای گروهها پرسشنامه Start Back جهت ارزیابی و تقسیم بندی بیماران مبتلا به کمردرد مزمن غیراختصاصی استفاده خواهد شد و همچنین برای ارزیابی شدت درد، ناتوانی، کیفیت زندگی، افسردگی/اضطراب و استرس ، کینزوفوبیا، خودکارامدی درد، فاجعه بار کردن درد، نوروفیزیولوژی درد، باورهای اجتناب از ترس و وجود حساسیت مرکزی از پرسشنامههای مربوطه استفاده میشود و به همین ترتیب 2 ماه پس از درمان 4 و 12 ماه پس از پایان مداخلات هر بار این متغییرها اندازهگیری میشوند. مداخلات در مرکز سلامت دانشگاه خوارزمی انجام خواهد شد.
افراد هدفدار به صورت تصادقی به سه گروه 3515 نفره تقسیم میشوند. در ابتدا به تمامی اعضای گروهها پرسشنامه Start Back جهت ارزیابی و تقسیم بندی بیماران مبتلا به کمردرد مزمن غیراختصاصی استفاده خواهد شد و همچنین برای ارزیابی شدت درد، ناتوانی، کیفیت زندگی، افسردگی/اضطراب و استرس ، کینزوفوبیا، خودکارامدی درد، فاجعه بار کردن درد، نوروفیزیولوژی درد، باورهای اجتناب از ترس و وجود حساسیت مرکزی از پرسشنامههای مربوطه استفاده میشود و به همین ترتیب 2 ماه پس از درمان 4 و 12 ماه پس از پایان مداخلات هر بار این متغییرها اندازهگیری میشوند. مداخلات در مرکز سلامت دانشگاه خوارزمی انجام خواهد شد.
General information
105
45
10545
Editing the sample size due to appropriate corrections on the test power values and the effect size of the main research variables.
It is respectfully requested that an update be made regarding the editing of the sample size due to the necessary corrections on the power values of the test and the effect size of the main research variables.
The sample size was calculated based on the following process:
Considering a repeated measure ANOVA test using effect size η=0.25, confidence level α=0.05, expected power 95%, number of groups 3, and by performing 4 measurement stages of the test Therefore, the total number of required samples was estimated to be 45 people (and in other words, 15 people in each group), the mentioned calculations were done using G*Power version 3.1.9.2 software (Faul, Erdfelder et al. 2007).
Sincerely, Soheili
EditingIt is respectfully requested that an update be made regarding the editing of the sample size due to appropriatethe necessary corrections on the test power values of the test and the effect size of the main research variables. The sample size was calculated based on the following process: Considering a repeated measure ANOVA test using effect size η=0.25, confidence level α=0.05, expected power 95%, number of groups 3, and by performing 4 measurement stages of the test Therefore, the total number of required samples was estimated to be 45 people (and in other words, 15 people in each group), the mentioned calculations were done using G*Power version 3.1.9.2 software (Faul, Erdfelder et al. 2007). Sincerely, Soheili
ویرایش حجم نمونه به علت اصلاحات مقتضی بر روی مقادیر توان ازمون و اندازه اثر متغیرهای اصلی پژوهش.
احتراما خواهشمند است بروز رسانی در خصوص ویرایش حجم نمونه به علت اصلاحات مقتضی بر روی مقادیر توان آزمون و اندازه اثر متغیر های اصلی پژوهش انجام پذیرد.
اندازه گیری حجم نمونه با استناد به فرایند زیر محاسبه گردید:
با در نظر گرفتن یک آزمون تجزیه تحلیل اندازه گیری مکرر (Repeated measure ANOVA) با استفاده از اندازه اثر η=0.25، سطح اطمینان α=0.05، توان مورد انتظار 95%، تعداد گروه 3، و با انجام 4 مرحله اندازه گیری از آزمون شوندگان، تعداد کل نمونه مورد نیاز 45 نفر (و به عبارتی 15 نفر در هر گروه) برآورد شد، محاسبات مورد اشاره با استفاده از نرم افزار G*Power نسخه 3.1.9.2انجام گردید (Faul, Erdfelder et al. 2007).
با احترام سهیلی
احتراما خواهشمند است بروز رسانی در خصوص ویرایش حجم نمونه به علت اصلاحات مقتضی بر روی مقادیر توان ازمونآزمون و اندازه اثر متغیرهایمتغیر های اصلی پژوهش انجام پذیرد. اندازه گیری حجم نمونه با استناد به فرایند زیر محاسبه گردید: با در نظر گرفتن یک آزمون تجزیه تحلیل اندازه گیری مکرر (Repeated measure ANOVA) با استفاده از اندازه اثر η=0.25، سطح اطمینان α=0.05، توان مورد انتظار 95%، تعداد گروه 3، و با انجام 4 مرحله اندازه گیری از آزمون شوندگان، تعداد کل نمونه مورد نیاز 45 نفر (و به عبارتی 15 نفر در هر گروه) برآورد شد، محاسبات مورد اشاره با استفاده از نرم افزار G*Power نسخه 3.1.9.2انجام گردید (Faul, Erdfelder et al. 2007). با احترام سهیلی
Protocol summary
Study aim
This study aims to compare the effectiveness of patient-led goal setting with pain neuroscience education and Manual therapy in patients suffering chronic low back pain.
Design
A sample population of 45 subjects was purposefully selected using G-power statistical software. The volunteers are then equally divided into 3 groups (control group, patient-led goal setting group with pain neuroscience education and patient-led goal setting group with manual therapy).
Settings and conduct
Targeted individuals are randomly assigned to 3 groups of 15 people. Initially, the Start Back questionnaire will be used to evaluate and classify patients suffering from nonspecific chronic low back pain. Additionally, appropriate questionnaires will be used to assess pain intensity, disability, quality of life, depression / anxiety and stress, kinesiophobia, pain self-efficacy, and catastrophic pain, neurophysiology of pain, beliefs about fear avoidance and the presence of central sensitivity. Accordingly, these variables will be measured 2, 4, and 12 months after the conclusion of the intervention.interventions will be performed in Kharazmi University Health Centre.
Participants/Inclusion and exclusion criteria
Inclusion criteria targets individuals aged 18 to 65 with a history of nonspecific low back pain.
Exclusion criteria individuals who have had spinal surgery in the past 12 months or report serious pathological signs and symptoms are excluded from this study.
Intervention groups
This study consists of three groups, including the control group, the patient-led goal setting group with pain neuroscience education, and the patient-led goal setting group with Manual therapy.
Main outcome variables
There is a difference between a patient-led goal-setting approach with patient leadership combined with pain neuroscience education or manual therapy on pain intensity in people with chronic low back pain.
General information
Reason for update
It is respectfully requested that an update be made regarding the editing of the sample size due to the necessary corrections on the power values of the test and the effect size of the main research variables.
The sample size was calculated based on the following process:
Considering a repeated measure ANOVA test using effect size η=0.25, confidence level α=0.05, expected power 95%, number of groups 3, and by performing 4 measurement stages of the test Therefore, the total number of required samples was estimated to be 45 people (and in other words, 15 people in each group), the mentioned calculations were done using G*Power version 3.1.9.2 software (Faul, Erdfelder et al. 2007).
Sincerely, Soheili
Acronym
IRCT registration information
IRCT registration number:IRCT20210927052616N1
Registration date:2021-11-03, 1400/08/12
Registration timing:registered_while_recruiting
Last update:2023-04-12, 1402/01/23
Update count:2
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
Sahar Soheili
Name of organization / entity
Kharazmi University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 2624
Email address
std_saharsoheili75@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of patient-led goal setting with pain neuroscience education and Manual therapy in Patients with chronic low back pain.
Public title
Evaluation of the effect of patient-led goal-setting approach in combination with pain neuroscience training or manual therapy in patients with chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of nonspecific low back pain
Minimum duration of low back pain is 3 months
They reported pain intensity with 4 out of 11 points in the NRS questionnaire and at least 20 points in the QBPDS.
Exclusion criteria:
Spinal surgery report in the last 12 months
Severe osteoporosis
Signs and symptoms reported from serious pathology
Spondyloarthritis
Spondylolisthesis
Spinal canal stenosis
Traumatic spinal cord injury such as a fracture or car accident
Spinal dislocation
Spinal cord metastasis
Has symptoms of Cauda Equina syndrome
Structural scoliosis
Pregnancy
History of seizures, epilepsy, stroke or head injuries
Taking medications for patients with mental health problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Following the baseline examination, by using the method shown on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants will be randomly assigned into the patient-led goal-setting approach group In combination with pain neuroscience education, the patient-led goal-setting approach group will be combined with manual therapy. Simple randomization will be used. Concealed allocation is performed using a computer-generated block randomized table of numbers (1 for patient-led goal-setting approach group In combination with pain neuroscience education and 2 for the patient-led goal-setting approach group will be combined with manual therapy) created before the start of data collection by a researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelopes. Another researcher, blind to the baseline examination, open an envelope and process with treatment according to the group assignment. An independent assessor who is not known about the study’s hypothesis and methods and is blind to the treatment group, assess the outcome measures before the interventions, 2 months after treatment, and 4 and 12 months after the end of the intervention, each time measured.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor was blinded of the process of randomization and division of individuals into two experimental and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institute of Physical Education and Sports Sciences
Street address
Saadat Abad, above Kaj Square, Ali Akbar St., No. 7
City
Tehran
Province
Tehran
Postal code
1998643551
Approval date
2021-08-21, 1400/05/30
Ethics committee reference number
IR.SSRC.REC.1400.084
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Numerical Rating Scale
2
Description
Kinesophobia
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Tampa Scale For Kinesiophobia
3
Description
Fear Avoidance Beliefs
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Fear Avoidance Beliefs Questionnare
4
Description
Disability
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Qubec Back Pain Disability Scale
5
Description
Quality Of Life
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
SF_36 Scale
6
Description
Anxiety
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Depression Anxiety Stress Scale
7
Description
Depression
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Depression Anxiety Stress Scale
8
Description
Stress
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Depression Anxiety Stress Scale
9
Description
Pain Self-efficacy
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Pain Self-Efficacy Questionnare
10
Description
Central Sensitivity Inventory
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Central Sensitization Inventory
11
Description
Catastrophic pain
Timepoint
First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
Method of measurement
Pain Catastrophizing Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patient-led goal setting group with Manual therapy. The goal-setting approach will be conducted over the course of 2 months through a one-hour face-to-face session followed by 4 sessions of 15 to 30 minutes over 2 weeks. Subsequently, two 30-minute sessions are performed with an interval of one month. Furthermore, twelve months after initiating the research the final session is performed and the results are collected. In this approach, the author has employed the SMART model which features measurable and achievable goal-setting processes that are specific to a time frame. In the aforementioned model, the researcher is trained in patient-led goal setting, takes the low back pain history of the patient into consideration, and engages in conversation regarding the consequences of their ailment. Moreover, the patient is asked to prioritize the problems based of their preferences. Afterward, strategies are considered based on evidence-based guidelines and the participant sets goals and chooses strategies to implement individually in between sessions. The participants will record their goals, progress, and obstacles and strategies to overcome the obstacles in their notebooks. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of 60 minutes over 6 weeks. For manual treatment, soft tissue mobilization techniques, muscle energy techniques, and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral, and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. The participant is asked to gently contract these muscles for 8 seconds with 30% of maximum contraction. This practice is repeated after each rest. The assessment of Joint mobilization is based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, and Piedallu Sign.
Category
Other
2
Description
Intervention group: patient-led goal setting group with Manual therapy.The goal-setting approach will be done with patient leadership over 2 months, which includes 5 face-to-face sessions, with the first session lasting one hour and the other four sessions lasting 15 to 30 minutes over two weeks. After that, two follow-up sessions (duration 30 minutes) are performed with an interval of one month. Also, one session is performed after 12 months after the first session and finally the results are collected. To perform this approach, a model called SMART is used, which includes a special process for goal setting that is measurable, achievable and related to a specific time return. In this model, the researcher is trained in setting goals by the patient, history of low back pain Considers the participant and talks about the problems caused by low back pain. Ask the participant to prioritize these problems based on what they want to focus on. Strategies are then discussed based on evidence-based guidelines, and the participant sets specific goals and strategies for the participants to work independently between sessions. They record what they agree to achieve in their workbook. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of treatment for 6 weeks and three times a week, each session lasting 60 minutes. For manual treatment, soft tissue mobilization techniques, muscle energy techniques and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. We ask the participant to gently contract these muscles for 8 seconds with 30% of maximum contraction. This movement is repeated after each rest. Joint mobilization is assessed based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, Piedallu Sign.
Category
Other
3
Description
Control group: Without receiving any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi University Health Center
Full name of responsible person
Sahar Soheili
Street address
No. 7, Ali Akbar St., above Kaj Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998643541
Phone
+98 21 2237 2624
Email
std_sahrsoheili75@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Kharazmi University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi 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
Kharazmi University
Full name of responsible person
Sahar Soheili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
no. 7, Ali Akbar Street, Above Pine Square, Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1998643541
Phone
+98 21 2237 2624
Email
std_saharsoheili75@khu.c.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Sahar Soheili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No. 7, Ali Akbar St., above Kaj Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998643541
Phone
+98 21 2237 2624
Email
std_saharsoheili75@khu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Sahar Soheili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
Saadat Abad, above Kaj Square, Ali Akbar St., No. 7
City
Tehran
Province
Tehran
Postal code
1998643541
Phone
+98 21 2237 2624
Email
std_saharsoheili75@khu.ac.ir
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