UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030141
Receipt number R000034426
Scientific Title The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study
Date of disclosure of the study information 2018/03/02
Last modified on 2018/03/08 05:05:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study

Acronym

Effects of Manual Therapy and Exercises on Forward Head and Rounded Shoulder Posture

Scientific Title

The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study

Scientific Title:Acronym

Effects of Manual Therapy and Exercises on Forward Head and Rounded Shoulder Posture

Region

Asia(except Japan)


Condition

Condition

Forward Head and Rounded Shoulder Posture

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of a six-week neck manual therapy plus stabilizing exercise, and one-month following, on forward head and round shoulder posture

Basic objectives2

Others

Basic objectives -Others

Differences between experimental groups and the control group

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Posture; Pain; Function

Key secondary outcomes



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

NO

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

Stabilizing Exercise; three sessions per week for six weeks

Interventions/Control_2

Manual interventions; three sessions per week for six weeks

Interventions/Control_3

Control; 3-time home exercise program weekly described postural correction on daily activities

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

32 years-old <=

Age-upper limit

42 years-old >=

Gender

Female

Key inclusion criteria

Cervical (CA > 46 degrees) and shoulder (SA > 52 degrees) angle measured with photogrammetry. The neck pain should be between three and eight based on visual analog scale and at least within the last three months.

Key exclusion criteria

Exclusion criteria were a history of cervical spine injury or surgery, neck pain secondary to other conditions (including neoplasm, neurological diseases or vascular diseases), a neurological deficit, infection, or inflammatory arthritis in the cervical spine, receiving physiotherapy within the last 6 months, and poor general health status that would interfere with the exercises over the study.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maliheh Haddadnezhad

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code


Address

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

TEL

00989123469464

Email

m.hadadnezhad@yahoo.com


Public contact

Name of contact person

1st name
Middle name
Last name Kiana Fatholahnezhad

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code


Address

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

TEL

00989132950114

Homepage URL


Email

fkianaz@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


Address


Tel


Email



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


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 25 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 30 Day

Last follow-up date


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 28 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name