UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030163
Receipt number R000034449
Scientific Title Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain
Date of disclosure of the study information 2018/03/02
Last modified on 2019/05/08 14:50:31

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Basic information

Public title

Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain

Acronym

Drawing-in maneuver using a pressure biofeedback unit to improve chronic neck pain

Scientific Title

Drawing-in maneuver using a pressure biofeedback unit for pain and muscular endurance in chronic neck pain

Scientific Title:Acronym

Drawing-in maneuver using a pressure biofeedback unit to improve chronic neck pain

Region

Asia(except Japan)


Condition

Condition

Chronic neck pain; Forward head posture

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of drawing-in maneuver using a pressure biofeedback unit with conservative training for relieving pain, and improving disability and deep cervical flexor muscular endurance in patients with neck pain and forward head posture

Basic objectives2

Others

Basic objectives -Others

Differences between deep craniocervical flexor training group and deep craniocervical flexor training with Drawing-in maneuver using PBU group anf differences between two experimental groups with control group

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Pain; Neck disability Index; Deep flexor muscular endurance

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Deep craniocervical flexor training; 35 minutes a day, three times a week for 8 weeks

Interventions/Control_2

Deep craniocervical flexor training with Drawing-in maneuver using PBU; 35 minutes a day, three times a week for 8 weeks

Interventions/Control_3

Control group; active self-exercise

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%). 3), and neck pain at least within the last three months

Key exclusion criteria

The exclusion criteria were as well 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

65


Research contact person

Name of lead principal investigator

1st name Amir
Middle name
Last name Letafatkar

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code

1571914911

Address

Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj

TEL

00989357365993

Email

letafatkaramir@yahoo.com


Public contact

Name of contact person

1st name Zohre
Middle name
Last name Khosrokiani

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code

157191491

Address

Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj

TEL

00989112133552

Homepage URL


Email

z.khosrokiani@gmail.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

Kharazmi University

Address

Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj, Alborz, Iran

Tel

02122222644

Email

kinresct.khu@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

2018 Year 03 Month 02 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

65

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

2017 Year 11 Month 26 Day

Date of IRB

2017 Year 11 Month 28 Day

Anticipated trial start date

2018 Year 01 Month 06 Day

Last follow-up date

2018 Year 05 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

2017 Year 11 Month 29 Day

Last modified on

2019 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034449


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name