UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038394
Receipt number R000043751
Scientific Title The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain
Date of disclosure of the study information 2019/11/08
Last modified on 2019/10/26 18:48:19

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Basic information

Public title

The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain

Acronym

The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain

Scientific Title

The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain

Scientific Title:Acronym

The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain

Region

Asia(except Japan)


Condition

Condition

pre-post intervention

Classification by specialty

Medicine in general Rehabilitation medicine Not applicable
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effect of neck movement pattern modifications on pain and function in females with nonspecific chronic neck pain

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain

Key secondary outcomes

performance


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Neck movement pattern modifications: 35 minutes a day, three times a week for 8 weeks

Interventions/Control_2

Control group; active self-exercise

Interventions/Control_3


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

Female

Key inclusion criteria

Inclusion criteria were pain between three and eight using VAS, neck disability index (NDI)(28-45%).

Key exclusion criteria

acute neck pain,
lasting less than three months,
a previous history of neck or back surgery and presence of other neurological or orthopedic disorders affecting the neck or back, and receiving muscle relaxant treatment.

Target sample size

30


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

4352763633

Address

tehran-mirdamad-sout razan street, faculty of PE

TEL

009802122258084

Email

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

4353663663

Address

tehran-mirdamad-sout razan street, faculty of PE

TEL

00989195394692

Homepage URL


Email

letafatkaramir@yahoo.com


Sponsor or person

Institute

kharazmi university

Institute

Department

Personal name



Funding Source

Organization

self-funding

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

kharazmi u iversity

Address

gisha bridge, jalal aleahmad , kharazmi university,tehran

Tel

982182883590

Email

healthcontrol@kharazmi.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 11 Month 08 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

30

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

2018 Year 06 Month 04 Day

Date of IRB

2018 Year 09 Month 10 Day

Anticipated trial start date

2018 Year 11 Month 02 Day

Last follow-up date

2019 Year 02 Month 13 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 10 Month 26 Day

Last modified on

2019 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name