UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Maliheh Haddadnezhad
Organization	Kharazmi University
Division name	Faculty of Physical Education and Sport Sciences
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	Kiana Fatholahnezhad
Organization	Kharazmi University
Division name	Faculty of Physical Education and Sport Sciences
Address	Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj
TEL	00989132950114
Homepage URL
Email	fkianaz@gmail.com

Sponsor
Institute	Kharazmi University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034426