UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044585 |
|---|---|
| Receipt number | 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 22:39:53 |
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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
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
njavdaneh68@gmail.com
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050925
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