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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044585
Receipt No. R000050925
Scientific Title Combining pain neuroscience education and therapeutic exercises for the treatment chronic neck pain
Date of disclosure of the study information 2021/06/17
Last modified on 2021/06/17

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Basic information
Public title adding pain neuroscience education to therapeutic exercises on pain and some cognitive variables in chronic neck pain
Acronym dding pain neuroscience education (PNE) to therapeutic exercises
Scientific Title Combining pain neuroscience education and therapeutic exercises for the treatment chronic neck pain
Scientific Title:Acronym Combining pain neuroscience education and therapeutic exercises
Region
Asia(except Japan)

Condition
Condition Pre- post
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Combining pain neuroscience education and therapeutic exercises for the treatment chronic neck pain
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neck Pain and Disability Scale (NPAD):The NPAD consists of 20 items. Each item has a VAS of 100 mm with numeric anchors at 0, 1, 2, 3, 4, and 5 (each 20 mm apart). Item scores range from 0 (no pain or limitation in activities) to 5 (as much pain as possible or maximal limitation).
Key secondary outcomes Fear-Avoidance Beliefs;Pain Catastrophizing;Pain self-efficacy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Therapeutic exercises
The compound and development of the therapeutic exercises were planed based on previous studies [33, 34]. The exercises were designed to improve the strength and endurance of the neck and scapula muscles
Interventions/Control_2 Pain neuroscience education
The compound and development of the pain neuroscience education intervention were planed based on previous studies [17, 36-38]. This intervention was performed based on international guidelines and included the nervous system's capability to regulate the pain perception, the neurophysiology of pain and becoming from acute to chronic pain.
Interventions/Control_3 8 week plasbo.The control group did not receive any intervention during the study. After the last measurement, they received a comprehensive rehabilitation program.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 20-50 years of age, current neck pain and bilateral CNP for at least 3 months
Key exclusion criteria Exclusion criteria were any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, physiotherapeutic treatment continued in the last 3 months and cognitive disorder that prohibited the pain neuroscience education intervention
Target sample size 66

Research contact person
Name of lead principal investigator
1st name Norollah
Middle name
Last name Javdaneh
Organization kharazmi university
Division name department of biomechanics and sport injuries
Zip code 009822258085
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00982122258084
Email njavdaneh68@gmail.com

Public contact
Name of contact person
1st name Norollah
Middle name
Last name javdaneh
Organization kharazmi university
Division name department of biomechanics and sport injuries
Zip code 009822258085
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00982122258084
Homepage URL
Email njavdaneh68@gmail.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sports Science Research Center
Address gisha bridge, jalal aleahmad , tarbiatmodares university,tehran
Tel 982182883590
Email njavdaneh68@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 17 Day

Related information
URL releasing protocol No
Publication of results Unpublished

Result
URL related to results and publications No
Number of participants that the trial has enrolled 72
Results Assessed for eligibility (n= 150)
Randomized (n= 72)
Results date posted
2021 Year 06 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 12 Month 17 Day
Baseline Characteristics NPAD, PSC, FABQ and PSEQ
Participant flow NPAD, PSC, FABQ and PSEQ
Adverse events NO
Outcome measures NPAD, PSC, FABQ and PSEQ
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 03 Month 07 Day
Date of IRB
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 05 Month 05 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
2020 Year 04 Month 02 Day
Date trial data considered complete
2020 Year 04 Month 05 Day
Date analysis concluded
2020 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2021 Year 06 Month 17 Day
Last modified on
2021 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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