UMIN-CTR Clinical Trial

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