Protocol summary

Summary
The purpose of this clinical study is to examine the effect of manual treatments on kyphosis improvement as compared with exercise therapy. Forty-six girls of the Shiraz University of Medical Sciences participate in this study and are divided randomly into two groups, exercise therapy and manual therapy. For both groups, 15 sessions of treatment during five weeks were done. Kyphosis angle and the back muscle strength are measured before and after tratment, using the motion analysis system and dynamometer. Since manual therapies (including massage, mobilization, muscle energy, and myofascial release) cause correct spinal alignment, facilitate joints movement and stretch shortened muscles, these techniques are expected to be effective in treatment of hyperkyphosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112188452N1
Registration date: 2012-01-05, 1390/10/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-05, 1390/10/15
Registrant information
Name
Maryam Mirshamsi
Name of organization / entity
Shiraz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 62 71552
Email address
mirshamsim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Research of the Shiraz University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between two methods of exercise therapy and manual therapy in treatment of the patients with postural hyperkyphosis
Public title
A comparison between two methods in treatment of hyperkyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria were:age between 18 – 30; the thoracic kyphosis degree of more than 45.Exclusion criteria:outside the age range of 18-30; Scoliosis; Fracture history in the spinal column; Spinal tumors and related malignancies; Congenital spinal anomalies; Cancer; Rheumatoid aAthritis.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz, First abiverdi Ave, Chamran Blv-
City
Shiraz
Postal code
Approval date
2011-06-27, 1390/04/06
Ethics committee reference number
CT-89-5524

Health conditions studied

1

Description of health condition studied
Hyperkyphosis
ICD-10 code
M40
ICD-10 code description
Kyphosis and lordosis

Primary outcomes

1

Description
Kyphosis angle
Timepoint
Befor and after treatment
Method of measurement
Motion analysis system

2

Description
Back muscle strength
Timepoint
Befor and after treatment
Method of measurement
Electronic dynamometer

Secondary outcomes

empty

Intervention groups

1

Description
Participants in the manual group were prescribed 15 sessions of manual treatments including massage, mobilization, muscle energy–mobilization, and myofascial release during five weeks.
Category
Treatment - Other

2

Description
Participants in the exercises group were prescribed 15 sessions of stretching and strengthening exercises during five weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Mirshamsi
Street address
Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research of the Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of the Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz university of Medical Sciences
Full name of responsible person
Dr Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of Medical Sciences
Full name of responsible person
Dr Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of Medical Sciences
Full name of responsible person
Dr Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
00
Fax
Email
fahimehkamali@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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