This study is a randomized clinical trial conducted on 90 patients with breast cancer after radical mastectomy at oncology center of Imam Khomeini Hospital (Meraj and Central) to determine the effect of manual lymph massage and low pressure bandage on pain, edema and shoulder function. Massage and bandage were performed by therapist and family or patient for a 1 month period on the operated arm. Pain intensity, arm edema and shoulder function were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810142983N1
Registration date:2011-05-14, 1390/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-14, 1390/02/24
Registrant information
Name
Reza Norouzadeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8800
Email address
norouzadeh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2009-09-24, 1388/07/02
Expected recruitment end date
2011-08-24, 1390/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of massage and bandage on pain, edema and shoulder function after radical mastectomy
Public title
Determining the effect of massage and bandage on pain, edema and arm function after mastectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: breast cancer diagnosis, candidate for mastectomy with axillary lymphatic dissection, presence of an assistant for massage and bandage procedure
Exclusion criteria: Underlying disorders affecting limb (arm) or lymphatic system
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Shahed University, Opposite Imam Khomeini Shrime, Tehran-Qom Highway, Tehran
City
Tehran
Postal code
Approval date
2009-02-21, 1387/12/03
Ethics committee reference number
37823
Health conditions studied
1
Description of health condition studied
Radical Mastectomy
ICD-10 code
Z90.1
ICD-10 code description
Acquired absence of breast(s)
Primary outcomes
1
Description
Lymphedema
Timepoint
first day after surgery and immediatly after end of intervention(s)
Method of measurement
SPDI index
2
Description
Pain severity
Timepoint
first day after surgery and immediatly after end of intervention(s)
Method of measurement
SPDI index
3
Description
Shoulder function
Timepoint
first day after surgery and immediatly after end of intervention(s)
Method of measurement
SPDI index
Secondary outcomes
empty
Intervention groups
1
Description
Daily Specialized massage on arm at operated side, each massage session was at least 15 minutes
Category
Rehabilitation
2
Description
Daily Specialized massage and low pressure bandage on arm at operated side, each massage session was at least 15 minutes, bandage was kept at least 6 hours by the patient
Category
Rehabilitation
3
Description
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital, cancer institute
Full name of responsible person
Reza Norouzadeh
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University, Research Center
Full name of responsible person
Zahra Kiasalari
Street address
Shahed University, Opposite Imam Khomeini Shrime, Tehran-Qom Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University, Research Center
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
Shahed University Research Center
Full name of responsible person
Maryam Askari
Position
Midwife, MSN
Other areas of specialty/work
Street address
North Kargar Ave., Shahed University Research Center
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 9772
Fax
Email
maya10sa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Reza Norouzadeh
Position
MSN
Other areas of specialty/work
Street address
Rahimzadeh Alley, Valiasr Street, Shahed Nursing and Midwifery Faculty
City
Tehran
Postal code
1591715314
Phone
+98 216641858790
Fax
+98 21 6641 8580
Email
reza_214@yahoo.comnorouzadeh@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Reza Norouzadeh
Position
MSN, Faculty Member
Other areas of specialty/work
Street address
Valiasr Street
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8587
Fax
+98 21 6641 8580
Email
reza_214@yahoo.comnorouzadeh@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)