UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063157 |
|---|---|
| Receipt number | R000072275 |
| Scientific Title | Comparison of the Effect of Neck Stabilization Exercises with and without Pain Neuroscience Education on Pain, Functional Disability, Range of motion and Proprioception in clients with NonSpecific Chronic Neck Pain. |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/03 04:20:09 |
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Basic information
Public title
Comparison of the Effect of Neck Stabilization Exercises with and without Pain Neuroscience Education on Pain, Functional Disability, Range of motion and Proprioception in clients with NonSpecific Chronic Neck Pain.
Acronym
Comparison of the Effect of Neck Stabilization Exercises with and without Pain Neuroscience Education on Pain, Functional Disability, Range of motion and Proprioception in clients with NonSpecific Chronic Neck Pain.
Scientific Title
Comparison of the Effect of Neck Stabilization Exercises with and without Pain Neuroscience Education on Pain, Functional Disability, Range of motion and Proprioception in clients with NonSpecific Chronic Neck Pain.
Scientific Title:Acronym
Comparison of the Effect of Neck Stabilization Exercises with and without Pain Neuroscience Education on Pain, Functional Disability, Range of motion and Proprioception in clients with NonSpecific Chronic Neck Pain.
Region
| Asia(except Japan) |
Condition
Condition
pre test - post test
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to compare the effect of neck stabilization exercises with and without pain neuroscience education (PNE) on pain, functional disability, range of motion, and proprioception in patients with chronic nonspecific neck pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity, Functional disability
Key secondary outcomes
Range of motion, Proprioception
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Neck stabilization exercises
Interventions/Control_2
Combined (stabilization + PNE)
Interventions/Control_3
Control
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
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged years with normal body mass index (BMI).
No fracture, dislocation, or disc herniation in the cervical spine.
No other chronic pain in other body regions.
No history of invasive or minimally invasive spinal treatments.
No use of psychotropic or neurological medications.
No migraine (screened using a questionnaire).
No obvious postural deformities or other visually detectable abnormalities that could affect the study.
Chronic nonspecific neck pain lasting more than 3 months.
Pain intensity between 5 and 7 on the Visual Analogue Scale (VAS).
Willingness to participate in the corrective exercise program.
Willingness to participate in the study and sign informed consent.
Key exclusion criteria
Irregular attendance at training sessions: missing 2 consecutive sessions or 3 total sessions.
Failure to complete the pre-test and post-test assessments.
Pain exacerbation during the exercise protocol.
Development of musculoskeletal pain in other body regions during the study.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Asiyeh |
| Middle name | |
| Last name | Haghshenas |
Organization
SBU
Division name
SBU
Zip code
145782958
Address
TEHRAN
TEL
989336487376
haghshenasasiyeh@gmail.com
Public contact
Name of contact person
| 1st name | Haghshenas |
| Middle name | |
| Last name | Haghshenas |
Organization
shahid behshti university
Division name
SBU
Zip code
145782958
Address
tehran
TEL
989336487376
Homepage URL
haghshenasasiyeh@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
sbu
Address
TEHRAN
Tel
989336487376
shahramsamakosh92@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
| 2026 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072275
