Effects of pain neuroscience training combined with neuromuscular exercises on pain, functional disability and psychological factors related to chronic low back pain: A study protocol for a randomized controlled trial.
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Protocol summary
In this a double-blind randomized controlled trial, 42 patients (men and women , aged 30 to 60) diagnosed with chronic low back pain will be randomly assigned to one of the following groups: (1) Pain Neuroscience Education plus Neuromuscular Exercises (21 people) and (2) the neuromuscular exercises (21 people).
In this a double-blind randomized controlled trial, 50 patients (men and women , aged 30 to 60) diagnosed with chronic low back pain will be randomly assigned to one of the following groups: (1) Pain Neuroscience Education plus Neuromuscular Exercises (25 people) and (2) the neuromuscular exercises (25people).
In this a double-blind randomized controlled trial, 4250 patients (men and women , aged 30 to 60) diagnosed with chronic low back pain will be randomly assigned to one of the following groups: (1) Pain Neuroscience Education plus Neuromuscular Exercises (2125 people) and (2) the neuromuscular exercises (21 people25people).
در این کارآزمایی بالینی تصادفی دو سو کور، 42 بیمار (مرد و زن، 30 تا 60 ساله) با تشخیص کمردرد مزمن به طور تصادفی به یکی از گروه های زیر تقسیم می شوند: (1) آموزش علوم اعصاب و درد به علاوه تمرینات عصبی عضلانی (21 نفر) و (2) تمرینات عصبی عضلانی( 21 نفر).
در این کارآزمایی بالینی تصادفی دو سو کور، 50بیمار (مرد و زن، 30 تا 60 ساله) با تشخیص کمردرد مزمن به طور تصادفی به یکی از گروه های زیر تقسیم می شوند: (1) آموزش علوم اعصاب و درد به علاوه تمرینات عصبی عضلانی (25 نفر) و (2) تمرینات عصبی عضلانی( 25نفر).
در این کارآزمایی بالینی تصادفی دو سو کور، 42 بیمار50بیمار (مرد و زن، 30 تا 60 ساله) با تشخیص کمردرد مزمن به طور تصادفی به یکی از گروه های زیر تقسیم می شوند: (1) آموزش علوم اعصاب و درد به علاوه تمرینات عصبی عضلانی (2125 نفر) و (2) تمرینات عصبی عضلانی( 21 نفر25نفر).
General information
42
50
4250
empty
Changing the sample size
Changing the sample size
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تغییر حجم نمونه
تغییر حجم نمونه
a researcher will generate the allocation sequence with a block size of two using an online random number generator (Random.org). Patients will be randomly assigned into one of two treatment groups in the ratio of 1:1 as follows: PNE plus NMS group (n = 21) or control group (n = 21). Randomization will be drawing a number from 1 to 42, prepared in advance and placed in sealed opaque envelopes in a box. Participants will be told which intervention they were randomized to at the end of the study, after eight weeks.
a researcher will generate the allocation sequence with a block size of two using an online random number generator (Random.org). Patients will be randomly assigned into one of two treatment groups in the ratio of 1:1 as follows: PNE plus NMS group (n = 25) or control group (n = 25). Randomization will be drawing a number from 1 to 50, prepared in advance and placed in sealed opaque envelopes in a box. Participants will be told which intervention they were randomized to at the end of the study, after eight weeks.
a researcher will generate the allocation sequence with a block size of two using an online random number generator (Random.org). Patients will be randomly assigned into one of two treatment groups in the ratio of 1:1 as follows: PNE plus NMS group (n = 2125) or control group (n = 2125). Randomization will be drawing a number from 1 to 4250, prepared in advance and placed in sealed opaque envelopes in a box. Participants will be told which intervention they were randomized to at the end of the study, after eight weeks.
یک محقق توالی تخصیص را با اندازه بلوک دو با استفاده از یک تولید کننده اعداد تصادفی آنلاین (Random.org) تولید می کند. بیماران به طور تصادفی به یکی از دو گروه درمانی به نسبت 1:1 به شرح زیر تقسیم خواهند شد: گروه PNE به علاوه NMS
(21 = n) یا گروه کنترل (n = 21). تصادفی سازی یک عدد از 1 تا 42 است که از قبل آماده شده و در پاکت های مات مهر و موم شده در یک جعبه قرار می گیرد. به شرکت کنندگان گفته می شود که در پایان مطالعه، پس از هشت هفته در کدام مداخله تصادفی شدند.
یک محقق توالی تخصیص را با اندازه بلوک دو با استفاده از یک تولید کننده اعداد تصادفی آنلاین (Random.org) تولید می کند. بیماران به طور تصادفی به یکی از دو گروه درمانی به نسبت 1:1 به شرح زیر تقسیم خواهند شد: گروه PNE به علاوه NMS
(25 = n) یا گروه کنترل (n = 25). تصادفی سازی یک عدد از 1 تا 50است که از قبل آماده شده و در پاکت های مات مهر و موم شده در یک جعبه قرار می گیرد. به شرکت کنندگان گفته می شود که در پایان مطالعه، پس از هشت هفته در کدام مداخله تصادفی شدند.
یک محقق توالی تخصیص را با اندازه بلوک دو با استفاده از یک تولید کننده اعداد تصادفی آنلاین (Random.org) تولید می کند. بیماران به طور تصادفی به یکی از دو گروه درمانی به نسبت 1:1 به شرح زیر تقسیم خواهند شد: گروه PNE به علاوه NMS (2125 = n) یا گروه کنترل (n = 2125). تصادفی سازی یک عدد از 1 تا 42 است50است که از قبل آماده شده و در پاکت های مات مهر و موم شده در یک جعبه قرار می گیرد. به شرکت کنندگان گفته می شود که در پایان مطالعه، پس از هشت هفته در کدام مداخله تصادفی شدند.
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: Ehsan Alvani
Full name of responsible person - Persian: احسان الوانی
Street address - English: Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
Street address - Persian: خیابان حصاری، بلوار میرداماد، دانشگاه خوارزمی، دانشکده تربیت بدنی و علوم ورزشی، آزمایشگاه بیومکانیک و ورزش های اصلاحی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 910 844 7211
Fax:
Email: Ehsanalvani90@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: Amir Letafatkar
Full name of responsible person - Persian: امیر لطافت کار
Street address - English: Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
Street address - Persian: خیابان حصاری، بلوار میرداماد، دانشگاه خوارزمی، دانشکده تربیت بدنی و علوم ورزشی، آزمایشگاه بیومکانیک و ورزش های اصلاحی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 910 844 7211
Fax:
Email: Ehsanalvani90@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: Ehsan AlvaniAmir Letafatkar Full name of responsible person - Persian: احسان الوانیامیر لطافت کار Street address - English: Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St Street address - Persian: خیابان حصاری، بلوار میرداماد، دانشگاه خوارزمی، دانشکده تربیت بدنی و علوم ورزشی، آزمایشگاه بیومکانیک و ورزش های اصلاحی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 910 844 7211 Fax: Email: Ehsanalvani90@gmail.com Web page address:
Protocol summary
Study aim
Effects of pain neuroscience training combined with neuromuscular exercises on pain, functional disability and psychological factors related to chronic low back pain
Design
In this a double-blind randomized controlled trial, 50 patients (men and women , aged 30 to 60) diagnosed with chronic low back pain will be randomly assigned to one of the following groups: (1) Pain Neuroscience Education plus Neuromuscular Exercises (25 people) and (2) the neuromuscular exercises (25people).
Settings and conduct
All participants will sign a written informed consent before enrolment. Participants will be informed about this study and how to register through advertisements in physical therapy centers in Tehran and social networks.
Participants/Inclusion and exclusion criteria
The patients with CLBP : primary complaints of low back pain. The exclusion criteria are: having any specific pathology in the spine such as disc herniation
Intervention groups
group 1:Pain Neuroscience Education (PNE) plus neuromuscular exercises (NMS)
PNE + NMS group patients will receive neuromuscular exercises three times a week along with neuroscience education. Also in this study, NSM will be used for men and women with CLBP. The protocol of NMS used follows the evidence in CLBP field.
group 2:neuromuscular exercises (NMS)
NMS group patients will only receive neuromuscular exercises without any other intervention three times a week.
In this study, NMS will be used for men and women with CLBP. Each training session consists of three stages.
Main outcome variables
-Pain -Disability- Fear-avoidance beliefs-Self-efficacy-Fear of movement
General information
Reason for update
Changing the sample size
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043384N2
Registration date:2023-03-17, 1401/12/26
Registration timing:prospective
Last update:2023-10-24, 1402/08/02
Update count:2
Registration date
2023-03-17, 1401/12/26
Registrant information
Name
Ehsan Alvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2402
Email address
ehsanalvani90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-30, 1402/01/10
Expected recruitment end date
2023-05-31, 1402/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pain neuroscience training combined with neuromuscular exercises on pain, functional disability and psychological factors related to chronic low back pain: A study protocol for a randomized controlled trial.
Public title
Effects of pain neuroscience training combined with neuromuscular exercises on chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Persian-native speaker (Male and Female )
- Primary complaints of low back pain (more than three months, usually between the lower ribs and the creased part of the buttocks without nonspecific pathoanatomical cause) diagnosed by an experienced physiotherapist and completion of the consent form.
Exclusion criteria:
-previous spinal surgery and neurological signs
specific spinal pathology (tumor, infection, fracture, inflammatory disease)
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
a researcher will generate the allocation sequence with a block size of two using an online random number generator (Random.org). Patients will be randomly assigned into one of two treatment groups in the ratio of 1:1 as follows: PNE plus NMS group (n = 25) or control group (n = 25). Randomization will be drawing a number from 1 to 50, prepared in advance and placed in sealed opaque envelopes in a box. Participants will be told which intervention they were randomized to at the end of the study, after eight weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Assessor and biostatistician will be blinded to group allocation. The investigators responsible for data analysis will use a coded dataset to ensure blinding. Patients will not be blinded to exercise study but will not know which treatment group they will be assigned to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sport Sciences Research Institute
Street address
No. 3,5th Alley,Miremad Street, Motahhari Street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2022-11-21, 1401/08/30
Ethics committee reference number
IR.SSRC.REC.1401.081
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 M54.5
Primary outcomes
1
Description
Pain Intensity
Timepoint
Data will be assessed at the three measurement time points from the participants:• Before intervention;• After 8 weeks of intervention• At 6-month follow-up
Method of measurement
In this study, pain will be measured using Visual Analogue Scale (VAS) scale. The VAS, a widely used psychometric response scale tool, measures participants’ pain severity. Participants will be asked to indicate the severity of their pain along the VAS, which is a horizontal line with 10 points along it. The beginning shows no pain (marked with a zero and an image of a smiling face), and its endpoint (marked with a 10 and a face in pain and discomfort) represents very severe pain. Its reliability and validity have been excellent, and its internal consistency has been well demonstrated.
Secondary outcomes
1
Description
Disability
Timepoint
Data will be assessed at the three measurement time points from the participants:• Before intervention;• After 8 weeks of intervention• At 6-month follow-up
Method of measurement
In the present study, The Persian version of the Oswestry questionnaire will be used to assess the degree of disability in participants with Chronic low back pain (CLBP) . This questionnaire includes 10 six-option items. These 10 items examine the performance of the individuals in their daily activities. Each item ranks the degree of disability in performance from zero (desired function with no feeling of pain) up to five (disability in performing the activity due to severe pain). The Oswestry disability index is equal to sum of the scores of these 10 items multiplied by 2, the value of which ranges from 0 to 100. A zero score indicates the person can perform daily activities with no pain. A 0-20 score indicates mild or minimal disability, 21-40 indicates moderate disability, 41-60 indicates severe disability, and 61-80 indicates crippling disability. Scores 81 and higher indicate the person is bed-bound or exaggerating symptoms. The validity of Oswestry questionnaire has been confirmed based on Cronbach alpha of 75%, and its reliability has been reported with a correlation coefficient of 0.92 using the test-retest method. The least clinically significant difference (MCD) in people with CLBP is 0.28.
2
Description
Fear-avoidance beliefs
Timepoint
Data will be assessed at the three measurement time points from the participants:• Before intervention;• After 8 weeks of intervention• At 6-month follow-up
Method of measurement
The Persian version of the Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to assess the patients' fear-avoidance beliefs during physical activity and work. It includes 16 items related to physical activity (FABQ-PA) and work (FABQ-W) affecting the patient’s LBP. As for FABQ-W, those with a score >34 or higher (out of a possible 42 points) have shown to be less likely to return to work by four weeks, whereas, in FABQ-PA, those with a score of 15 (out of a possible 24 points) have revealed Fear-Avoidance beliefs related to physical activities. The Persian version of the FABQ has been reported to be a valid and reliable (ICC= 0.80) measure of Fear-Avoidance beliefs in patients with CLBP. The least clinically significant difference (MCD) in people with CLBP is 5.95.
3
Description
Self-efficacy
Timepoint
Data will be assessed at the three measurement time points from the participants:• Before intervention;• After 8 weeks of intervention• At 6-month follow-up
Method of measurement
The Persian version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to assess self-efficacy. The questionnaire has been found to be a valid and reliable (ICC= 0.92) measure of pain self-efficacy beliefs). The PSEQ is a 10-item questionnaire ranging from 0 to 60 to assess patients’ confidence about their ability to perform a range of activities despite pain. For example: “I can do most of the household chores (e.g., tidying up, washing dishes), despite the pain” and “I can gradually increase my activity level, despite the pain. Lower scores for the PSEQ indicate lower levels of confidence. The least clinically significant difference (MCD) in people with CLBP is 5.5.
4
Description
Fear of movement
Timepoint
Data will be assessed at the three measurement time points from the participants:• Before intervention;• After 8 weeks of intervention• At 6-month follow-up
Method of measurement
The Tampa Scale of Kinesiophobia (TSK) measures “fear of movement” or “kinesiophobia” in the patient. The total score on this scale is between, 17 to 68. For example, a score of 68 showed severe fear of movement, 37 indicates there is fear of movement and where 17 means no fear. It is translated and validated into Persian and has been reported (ICC test-retest = 0.86) (Cronbach’s Alpha was 0.796 in 17 items). The least clinically significant difference (MCD) in people with CLBP is 0.18).
Intervention groups
1
Description
Intervention group: A neuroscience and pain training protocol along with a neuromuscular exercise protocol will be performed three times a week for eight weeks. The neuroscience training protocol includes the following: - Basic explanation of the structure of the brain and nerves, peripheral nervous system and central nervous system. Thresholds of action - Explaining the process of restraining and promoting the spine - Explaining the types of sensations and the transfer process - Explaining the basic concept of neuroplasticity. The neuromuscular training protocol includes the following: - Modified crawl-up exercise - Bird dog exercise - Side bridge exercise - Single stretch exercise Leg - shoulder bridge exercise - Tai Chi warrior exercise
Category
Treatment - Other
2
Description
Control group: they will perform a protocol of neuromuscular exercises three times a week for eight weeks and will not participate in any other treatment plan. The neuromuscular training protocol includes the following: - Modified crawl-up exercise - Bird dog exercise - Side bridge exercise - Single stretch exercise Leg - shoulder bridge exercise - Tai Chi warrior exercise
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadis Clinic
Full name of responsible person
Ehsan Alvani
Street address
Shariati Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 910 844 7211
Email
Ehsanalvani90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 910 844 7211
Email
Ehsanalvani90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Ehsan Alvani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 910 844 7211
Email
Ehsanalvani90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Ehsan Alvani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 910 844 7211
Email
Ehsanalvani90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Ehsan Alvani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Biomechanics and Corrective Exercise Laboratory, Faculty of Physical Education and Sport sciences, Kharazmi University, Mirdamad Blvd., Hesari St
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
021222280001
Email
Ehsanalvani90@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