UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036565 |
|---|---|
| Receipt number | R000041660 |
| Scientific Title | Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in patients with chronic neck pain |
| Date of disclosure of the study information | 2019/07/20 |
| Last modified on | 2020/05/01 20:37:01 |
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Basic information
Public title
Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in patients with chronic neck pain
Acronym
Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in patients with chronic neck pain
Scientific Title
Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in patients with chronic neck pain
Scientific Title:Acronym
Efficacy of deep cervical flexor motor-control training with and without lumbar muscle motor control training in patients with chronic neck pain
Region
| Asia(except Japan) |
Condition
Condition
pre-post intervention
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether adding lumbar motor control training with a pressure biofeedback unit (PBU) improves outcomes of a conservative deep cervical flexor (DCF) motor control program on neck pain, neck disability, and DCF endurance in middle-aged women with moderate chronic NP and FHP compared to a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain
Key secondary outcomes
disability,
posture
health status
endurance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Conventional Group / 2 months
Interventions/Control_2
Conventional + MCE using PBU exercise Group/ 2 months
Interventions/Control_3
postural corrections
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
women with moderately severe,
chronic NP we included women who rated their worst pain over the last 24-hours between three and eight using the visual analog scale (VAS),
baseline neck disability index (NDI) scores between 28% and 45% and pain lasting longer than 3 months.
Key exclusion criteria
acute NP less than three months,
previous history of neck or back surgery,
presence of neurological signs,
rheumatoid arthritis affecting the neck or back,
currently using muscle relaxer medication
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Amir |
| Middle name | |
| Last name | Letafatkar |
Organization
kharazmi University
Division name
department of corrective exercises and sport injuries
Zip code
009822258085
Address
tehran-mirdamad-sout razan street, faculty of PE
TEL
009802122258084
letafatkaramir@yahoo.com
Public contact
Name of contact person
| 1st name | Amir |
| Middle name | |
| Last name | letafatkar |
Organization
kharazmi University
Division name
department of biomechanics and sport injuries
Zip code
009822258085
Address
tehran-mirdamad-sout razan street, faculty of PE
TEL
00989195394692
Homepage URL
letafatkaramir@yahoo.com
Sponsor or person
Institute
kharazmi university
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
tarbiatmodares university
Address
gisha bridge, jalal aleahmad , tarbiatmodares university,tehran
Tel
982182883590
healthcontrol@modares.ac.ir
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
| 2019 | Year | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
