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Evaluation of adding Pain neuroscience education to Pilates exercises on reducing on pain and improving function and psychological variables in individuals with knee osteoarthritis

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History
# Registration date Revision Id
3 2023-06-22, 1402/04/01 279395
2 2021-11-02, 1400/08/11 246380
1 2021-07-07, 1400/04/16 189398
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  • Trial results

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    Yes
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    2023-09-19, 1402/06/28
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    2023-06-06, 1402/03/16
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    https://doi.org/10.1186/s13075-023-03079-7
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    https://doi.org/10.1186/s13075-023-03079-7

             Table 2. Baseline demographic data by intervention group

    Characteristic Total sample (n = 54) PNE followed by PE (n=27) PE (n=27)
    Age, y 60.5±5.6 59.8±5.1 61.2±6.1
    Body height, cm 166.2±6.5 167.3±5.3 164.7±7.3
    Body mass, kg 81.2±10.6 82.1±10.1 80.1±11.2
    Body mass index, kg/m2 29.5±4.4 29.3±3.4 29.7±5.3
    Sex, n (%)
    Female 22 (40.7) 9 (40.9) 13 (59.1)
    Male 32 (59.3) 18 (56.3) 14 (43.8)
    VAS pain rating (0-100) 54.1±13.2 56.3 ±13.3 51.7±12.8
    Pain duration, y 7.8±4.5 7.6 ±4.7 6.7±4.0
    Unilateral symptoms, n (%) 13 (24.1) 8 (29.6) 5 (18.5)
    Smoking status, n (%)
    Never smoked 36 (66.7) 17 (63.0) 19 (70.4)
    Current 9 (16.7) 5 (18.5) 4 (14.8)
    Past 9 (16.7) 5 (18.5) 4 (14.8)
    Education level, n (%)
    High school or less 27 (50) 12 (44.4) 15 (55.6)
    Bachelor’s degree 18 (33.3) 10 (37) 8 (29.6)
    Master’s degree or higher 9 (16.7) 5 (18.5) 4 (14.8)
    Marital status, n (%)
    Married 37 (68.5) 17 (63.0) 20 (74.1)
    Single 3 (5.6) 2 (7.4) 1 (3.7)
    Separated/divorced/widowed 14 (25.9) 8 (29.6) 6 (22.2)

    Abbreviations: Continuous variables were expressed as mean and standard deviation (SD) and categorical variables as number (n) and percentage (%); VAS, Visual Analog Scale.

    جدول 2. اطلاعات دموگرافیک اولیه بر اساس گروه های مداخله.

    متغیر مجموع (n = 54) آموزش عصبی درد همراه با پیلاتس (n=27)  پیلاتس (n=27)
    سن (سال) 60.5±5.6 59.8±5.1 61.2±6.1
    قد (سانتی متر) 166.2±6.5 167.3±5.3 164.7±7.3
    وزن( کیلوگرم) 81.2±10.6 82.1±10.1 80.1±11.2
    شاخص توده بدن( کیلوگرم متر به توان 2) 29.5±4.4 29.3±3.4 29.7±5.3
    جنسیت, تعداد (%)
    زن (40.7)22   (40.9)9 13 (59.1)
    مرد (59.3)32  (56.3)18  14 (43.8)
    مقیاس بصری درد (100-0) 54.1±13.2  56.3±13.3 51.7±12.8
    دوره درد(سال) 7.8±4.5  7.6±4.7 6.7±4.0
    علائم یکطرفه, تعداد (%) (24.1)13  (29.6)8  (18.5)5 
    وضعیت سیگار کشیدن, تعداد (%)
    هرگز سیگار نکشیده  (66.7)36  17 (63.0) 19 (70.4)
    اخیرا  (16.7)9 5 (18.5) 4 (14.8)
    قبلا  (16.7)9 5 (18.5) 4 (14.8)
    میزان تحصیلات, تعداد (%)
    دبیرستان و مقطع پایین تر (50)27  (44.4)12  (55.6)15 
    کارشناسی (33.3)18  (37)10  (29.6)8 
    کارشناسی ارشد و مقطع بالاتر (16.7)9  (18.5)5  (14.8)4 
    وضعیت تاهل, تعداد (%)
    متاهل (68.5)37  (63.0)17  (74.1)20 
    مجرد (5.6)3  (7.4)2   (3.7)1
    طلاق/همسر فوت شده (25.9)14  (29.6)8  (22.2)6 

    اختصارات: متغیرهای پیوسته به صورت میانگین و انحراف معیار (SD) و متغیرهای طبقه بندی شده به صورت عدد (n) و درصد (%) بیان شدند.

    https://doi.org/10.1186/s13075-023-03079-7

    https://doi.org/10.1186/s13075-023-03079-7

    Table 3. Within- and between-group differences in primary and secondary outcome measures based on the general linear mix model analysis

    Variables Group Baseline Mean (SD) Eight weeks Mean (SD) Change relative to baseline (%) Group Difference, Mean (95% CI) a ES (ηp2) † P-value
    Pain (0-20) PNE followed by PE 10.6 (2.8) 7.3 (2.3) -31.1 -0.8 (-2.2 to 0.7) 0.04 0.288
    PE 10.7 (3.2) 8.1 (2.9) -24.3
    Physical limitation (0-68) PNE followed by PE 29 (8.4) 22.7 (7.2) -21.7 -0.4 (-4 to 3.1) 0.02 0.812
    PE 28.5 (7.5) 23.1 (5.9) -18.9
    Pain catastrophizing (0-52) PNE followed by PE 26.1 (7.2) 16.2 (5.6) -37.9 -3.9 (-7.2 to -0.6) 0.51¥ 0.021
    PE 24.9 (8) 20.1 (6.5) -19.3
    Kinesiophobia (17-68) PNE followed by PE 43.7 (7.8) 34.3 (7.3) -21.5 -4.2 (-8.1 to -0.4) 0.39¥  0.032
    PE 42.9 (7.5) 38.5 (6.8) -10.3
    Self-efficacy (0-60) PNE followed by PE 34.1 (7.5) 47.9 (7.2) 40.5 6.1 (0.7 to 11.5) 0.13 0.028
    PE 34.4 (11.8) 41.8 (12.0) 21.5
    Function (s) PNE followed by PE 12.1 (2) 9.2 (1.6) -24 -0.8 (-1.8 to 0.1) 0.05 0.069
    PE 12.2 (2.1) 10.1 (1.8) -17.2

    Abbreviations: †, Effect size (partial eta squared); ¥, Large effect size (0.14); CI, Confidence Interval; PE, Pilates exercises; PNE followed by PE, Pain neuroscience education followed by Pilates exercises.

    جدول 3. تفاوت های درون گروهی و بین گروهی در متغیرهای اولیه و ثانویه بر اساس تحلیل مدل ترکیبی خطی.

    متغیرها گروه میانگین پیش آزمون(انحراف استاندارد) میانگین پس آزمون (انحراف استاندارد) درصد تغیرات نسبت به پیش آزمون تفاوت میانگین گروه ها (95% CI)  اندازه اثر(ηp2) † P-value
    درد (20-0) آموزش عصبی درد همراه با پیلاتس (2.8)10.6   (2.3)7.3 31.1-  (2.2-  0.7)0.8- 0.04 0.288
    پیلاتس (3.2)10.7  (2.9)8.1  24.3-
    محدودیت جسمانی(68-0) آموزش عصبی درد همراه با پیلاتس (8.4)29  (7.2)22.7  21.7-  (-4 to 3.1)0.4- 0.02 0.812
    پیلاتس (7.5)28.5  (5.9)23.1  18.9-
    فاجعه سازی درد (52-0) آموزش عصبی درد همراه با پیلاتس (7.2)26.1  (5.6)16.2  37.9-  (-7.2 to -0.6)3.9- 0.51¥ 0.021
    پیلاتس (8)24.9  (6.5)20.1  19.3-
    ترس از حرکت(68-17) آموزش عصبی درد همراه با پیلاتس (7.8)43.7   (7.3)34.3 21.5-  (-8.1 to -0.4)4.2- 0.39¥  0.032
    پیلاتس (7.5)42.9  (6.8)38.5  10.3-
    خودکارآمدی (60-0) آموزش عصبی درد همراه با پیلاتس (7.5)34.1  (7.2)47.9  40.5  (0.7 to 11.5)6.1 0.13 0.028
    پیلاتس  (11.8)34.4 (12.0)41.8  21.5
    عملکرد (ثانیه) آموزش عصبی درد همراه با پیلاتس  (2)12.1 (1.6)9.2  24-  (-1.8 to 0.1)0.8- 0.05 0.069
    پیلاتس  (2.1)12.2 (1.8)10.1  17.2-

    اختصارات: †، اندازه اثر (پارشیال اتا). ¥، اندازه اثر بزرگ (0.14)؛ CI، فاصله اطمینان.

    No serious adverse events were reported in any of the intervention groups. Protocol deviations or adjustments did not occur for both group.

    هیچ عارضه جانبی جدی در هیچ یک از گروه های مداخله گزارش نشد. تغییر یا دستکاری پروتکل برای هیچ یک از دو گروه رخ نداد.

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    Results Significant within-group differences were observed in all outcomes in both groups at post-treatment. There were no statistically between-group differences in pain (adjusted mean difference: -0.8; 95% CI -2.2 to 0.7; p = 0.288), physical limitation (adjusted mean difference: -0.4; 95% CI -4 to 3.1; p = 0.812) and function (adjusted mean difference: -0.8; 95% CI -1.8 to 0.1; p = 0.069) at eight weeks. For pain catastrophizing (adjusted mean difference: -3.9; 95% CI -7.2 to -0.6; p = 0.021), kinesiophobia (adjusted mean difference: -4.2; 95% CI -8.1 to -0.4; p = 0.032), and self-efficacy (adjusted mean difference: 6.1; 95% CI 0.7 to 11.5; p = 0.028) statistically between-group improvements were observed favoring PNE followed by PEs group after the treatment.
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    نتایج در تمام پیامدها در هر دو گروه پس از درمان، تفاوت‌های درون گروهی قابل‌توجهی مشاهده شد. هیچ تفاوت آماری بین گروهی در درد (تفاوت میانگین تعدیل شده: 0.8-؛ 95% فاصله اطمینان (CI): 2.2- تا 0.7؛ p = 0.288)، محدودیت جسمانی (تفاوت میانگین تعدیل شده: -0.4؛ 95% فاصله اطمینان (CI): -4- تا 3.1؛ p. = 0.812) و عملکرد (تفاوت میانگین تعدیل شده: -0.8؛ 95% فاصله اطمینان (CI): 1.8- تا 0.1؛ p = 0.069) در هشت هفته وجود نداشت. برای فاجعه سازی درد (تفاوت میانگین تعدیل شده: -3.9؛ 95% فاصله اطمینان (CI): 7.2- تا 0.6-؛ p = 0.021)، کینزیوفوبیا (تفاوت میانگین تعدیل شده: -4.2؛ 95% فاصله اطمینان (CI): 8.1- تا 0.4-؛ p 03 ) و خودکارآمدی (اختلاف میانگین تعدیل شده: 6.1؛ 95% فاصله اطمینان (CI): 0.7 تا 11.5؛ p = 0.028) از نظر آماری بهبودهای بین گروهی به نفع گروه اموزش عصبی درد همراه با پیلاتس پس از درمان مشاهده شد.

Protocol summary

Study aim
Evaluating if pain neuroscience education plus Pilates exercises will be superior to Pilates exercises on reducing pain and improving function, pain Catastrophizing, kinesiophobia, and self-efficacy in patients with knee OA.
Design
Two arms, randomised trial with blinded outcome assessment
Settings and conduct
Assessments are before and after interventions through blind assessor. Indexes for pain, pain catastrophizing, kinesiophobia, and self- efficacy are filled by patients online. The function assessment is at biomechanics laboratory at Kharazmi university. Education sessions are online, and Pilates exercises are on the health center of Kharazmi university.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female above 45 years old, primary complaint of knee OA by an orthopedic physician. Exclusion criteria: knee replacement or any other lower limb surgery, history of inflammatory, metabolic or neurological disease, knee ligament or meniscus injury
Intervention groups
The experimental group includes patients with knee osteoarthritis who receive pain neuroscience education plus Pilates exercises. The control group includes patients with knee osteoarthritis who receive Pilates exercises. Education includes 3 individualized sessions held by a physical therapist. It reframes the patient's negative beliefs about pain by providing information about the nature of pain. This approach can reduce fear avoidance and avoidance behavior, and increase self-efficacy. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis.
Main outcome variables
Pain, function, pain Catastrophizing, kinesiophobia, and self-efficacy

General information

Reason for update
Adding the start and end dates of the actual subject recruitment and the date of study ending.
Acronym
IRCT registration information
IRCT registration number: IRCT20210701051754N1
Registration date: 2021-07-07, 1400/04/16
Registration timing: prospective

Last update: 2023-09-19, 1402/06/28
Update count: 2
Registration date
2021-07-07, 1400/04/16
Registrant information
Name
Pouya Rabiei
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 86 3403 1371
Email address
pouya.rabiei.pr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
2021-07-13, 1400/04/22
Actual recruitment end date
2021-11-01, 1400/08/10
Trial completion date
2022-03-11, 1400/12/20
Scientific title
Evaluation of adding Pain neuroscience education to Pilates exercises on reducing on pain and improving function and psychological variables in individuals with knee osteoarthritis
Public title
Effect of Pilates with pain education in improvement of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Persian-native speaker male and female Being above 45 years old Having primary complaint of knee pain diagnosed as knee OA (>3 months’ duration) by an orthopedic physician.
Exclusion criteria:
Having self-reported knee replacement or any other lower limb surgery 6 months prior to participation, Having a history of inflammatory, metabolic or neurological disease, Having knee ligament or meniscus injury in previous year, Having any mental health conditions Using therapeutic modalities 6 months before participation.
Age
From 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 44
Actual sample size reached: 54
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 pain neuroscience education plus Pilates exercises group and Pilates exercises group. Simple randomization will be used. Concealed allocation is performed using a computer-generated block randomized table of numbers (1 for pain neuroscience education plus Pilates exercises group and 2 for Pilates exercises group) 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, and 8 weeks after interventions.
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
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
2021-05-19, 1400/02/29
Ethics committee reference number
IR.SSRC.REC.1400.033

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain intensity
Timepoint
Before the intervention and after 8 weeks after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis (WOMAC) Index

Secondary outcomes

1

Description
Function
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Timed “Up & Go” (TUG) test

2

Description
Pain Catastrophizing
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Pain Catastrophizing Scale (PCS)

3

Description
Kinesiophobia
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Tampa Scale for Kinesiophobia (TSK)

4

Description
Self-efficacy
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Pain Self-Efficacy Questionnaire (PSEQ)

5

Description
Physical activity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis (WOMAC) Index

Intervention groups

1

Description
Intervention group: Individuals in this group receive 3 sessions of pain neuroscience education and 24 session (for 8 weeks) Pilates exercises. Education includes 3 individualized sessions (30 and 60 minutes) held by a physical therapist. It reframes the patient's negative beliefs about pain by providing information about the nature of pain. This approach can reduce fear avoidance and avoidance behavior, and increase self-efficacy. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis.
Category
Rehabilitation

2

Description
Control group: This group only receive Pilates exercises. Each Pilates exercises session (24 in total) will be held by a physical therapist and take 60 minutes including warm-up, exercises, and cool-down. The number of repetitions is started from 5 and gradually increased according to the patient's ability. Exercises are based on the previous studies on knee osteoarthritis.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Heath center of the Kharazmi university
Full name of responsible person
Pouya Rabiei
Street address
No 38, Shokofeh St. Mehrshahr
City
Karaj
Province
Alborz
Postal code
3186689314
Phone
+98 86 3403 1371
Email
Pouya.rabiei.pr@gmail.com

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, Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This study has been conducted by the researchers and no organizational fund has been received
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Science
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
sports science
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Amir Letafatkar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports science
Street address
Center for Human Movement Sciences Kharazmi University Mirdamad, Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com

Sharing plan

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 demographic and outcomes-related data will be shared.
When the data will become available and for how long
After publishing paper(s) extracted from the study.
To whom data/document is available
The data can be displayed and shared at the reasonable request of the Iranian Clinical Trial Registration Center, journals, and university individuals /researchers who are conducting research and scientific activities in this field.
Under which criteria data/document could be used
Data analysis and the use of documentation can only be done provided that their results are reported in systematic review articles by academic researchers and authors. Requirements for sharing data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the study researchers/authors 2. A brief and logical explanation of how to use the data or documentation 3. Ensuring that the protocol for systematic review studies, requesting access to data or documentation, is recorded.
From where data/document is obtainable
Through asking from Authors Pouya Rabiei Pouya.rabiei.pr@gmail.com Amir Letafatkar letafatkaramir@yahoo.com Bahram Sheikhi sheikhibahram@gmail.com
What processes are involved for a request to access data/document
The applicant can request details from the researchers within 7 to 10 days using the message sent by email.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2023-09-19, 1402/06/28
Table of baseline comparison

         Table 2. Baseline demographic data by intervention group

Characteristic Total sample (n = 54) PNE followed by PE (n=27) PE (n=27)
Age, y 60.5±5.6 59.8±5.1 61.2±6.1
Body height, cm 166.2±6.5 167.3±5.3 164.7±7.3
Body mass, kg 81.2±10.6 82.1±10.1 80.1±11.2
Body mass index, kg/m2 29.5±4.4 29.3±3.4 29.7±5.3
Sex, n (%)
Female 22 (40.7) 9 (40.9) 13 (59.1)
Male 32 (59.3) 18 (56.3) 14 (43.8)
VAS pain rating (0-100) 54.1±13.2 56.3 ±13.3 51.7±12.8
Pain duration, y 7.8±4.5 7.6 ±4.7 6.7±4.0
Unilateral symptoms, n (%) 13 (24.1) 8 (29.6) 5 (18.5)
Smoking status, n (%)
Never smoked 36 (66.7) 17 (63.0) 19 (70.4)
Current 9 (16.7) 5 (18.5) 4 (14.8)
Past 9 (16.7) 5 (18.5) 4 (14.8)
Education level, n (%)
High school or less 27 (50) 12 (44.4) 15 (55.6)
Bachelor’s degree 18 (33.3) 10 (37) 8 (29.6)
Master’s degree or higher 9 (16.7) 5 (18.5) 4 (14.8)
Marital status, n (%)
Married 37 (68.5) 17 (63.0) 20 (74.1)
Single 3 (5.6) 2 (7.4) 1 (3.7)
Separated/divorced/widowed 14 (25.9) 8 (29.6) 6 (22.2)

Abbreviations: Continuous variables were expressed as mean and standard deviation (SD) and categorical variables as number (n) and percentage (%); VAS, Visual Analog Scale.

Participant flow diagram

https://doi.org/10.1186/s13075-023-03079-7

Table of variable outcomes' results

Table 3. Within- and between-group differences in primary and secondary outcome measures based on the general linear mix model analysis

Variables Group Baseline Mean (SD) Eight weeks Mean (SD) Change relative to baseline (%) Group Difference, Mean (95% CI) a ES (ηp2) † P-value
Pain (0-20) PNE followed by PE 10.6 (2.8) 7.3 (2.3) -31.1 -0.8 (-2.2 to 0.7) 0.04 0.288
PE 10.7 (3.2) 8.1 (2.9) -24.3
Physical limitation (0-68) PNE followed by PE 29 (8.4) 22.7 (7.2) -21.7 -0.4 (-4 to 3.1) 0.02 0.812
PE 28.5 (7.5) 23.1 (5.9) -18.9
Pain catastrophizing (0-52) PNE followed by PE 26.1 (7.2) 16.2 (5.6) -37.9 -3.9 (-7.2 to -0.6) 0.51¥ 0.021
PE 24.9 (8) 20.1 (6.5) -19.3
Kinesiophobia (17-68) PNE followed by PE 43.7 (7.8) 34.3 (7.3) -21.5 -4.2 (-8.1 to -0.4) 0.39¥  0.032
PE 42.9 (7.5) 38.5 (6.8) -10.3
Self-efficacy (0-60) PNE followed by PE 34.1 (7.5) 47.9 (7.2) 40.5 6.1 (0.7 to 11.5) 0.13 0.028
PE 34.4 (11.8) 41.8 (12.0) 21.5
Function (s) PNE followed by PE 12.1 (2) 9.2 (1.6) -24 -0.8 (-1.8 to 0.1) 0.05 0.069
PE 12.2 (2.1) 10.1 (1.8) -17.2

Abbreviations: †, Effect size (partial eta squared); ¥, Large effect size (0.14); CI, Confidence Interval; PE, Pilates exercises; PNE followed by PE, Pain neuroscience education followed by Pilates exercises.

Table of adverse events

No serious adverse events were reported in any of the intervention groups. Protocol deviations or adjustments did not occur for both group.

First publication date
2023-06-06, 1402/03/16
Abstract of published paper
Results Significant within-group differences were observed in all outcomes in both groups at post-treatment. There were no statistically between-group differences in pain (adjusted mean difference: -0.8; 95% CI -2.2 to 0.7; p = 0.288), physical limitation (adjusted mean difference: -0.4; 95% CI -4 to 3.1; p = 0.812) and function (adjusted mean difference: -0.8; 95% CI -1.8 to 0.1; p = 0.069) at eight weeks. For pain catastrophizing (adjusted mean difference: -3.9; 95% CI -7.2 to -0.6; p = 0.021), kinesiophobia (adjusted mean difference: -4.2; 95% CI -8.1 to -0.4; p = 0.032), and self-efficacy (adjusted mean difference: 6.1; 95% CI 0.7 to 11.5; p = 0.028) statistically between-group improvements were observed favoring PNE followed by PEs group after the treatment.
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