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The effect of ultrasound and Faradic under pressure on upper limb pain, swelling and function in patients with breast cancer after surgery

Protocol summary

Summary
The primary aim of this study is to investigate the effect of ultrasound and Faradic under pressure on upper limb pain, swelling and function in patients with breast cancer after surgery. In this study 45 patients participate who were randomly divided into three groups of 15 people. The first group receive conventional therapy (complex decongestive therapy) which includes four stages: gentle massage for lymph drainage, compression therapy with bandages, skin care and exercise. The second group, in addition to conventional therapy, receive ultrasound therapy with the intensity of 2 Watt / cm2 and with the frequency of 1 MHz in the arm, forearm and hand. The third group, in addition to conventional therapy, receive faradic under pressure flow. In all groups, measurements obtained by measuring the difference in volume between the two sides in various locations and measuring the difference between the volumes of fluid displacement, the pain using a scale to measure pain (numeric analog scale), and evaluate performance based on questionnaires DASH (Disability of Arm Shoulder Hand), those measured before treatment and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310292391N14
Registration date: 2016-01-03, 1394/10/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-09, 1394/10/19
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ultrasound and Faradic under pressure on upper limb pain, swelling and function in patients with breast cancer after surgery
Public title
The effect of electrotherapy modalities on pain and swelling in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions criteria: Women with a history of breast cancer for at least the age of 18 ; for at least surgery and chemotherapy or surgery and radiation therapy ; suffering lymph edema Exclusion criteria: Malignancies, including malignant lymph edema, bilateral breast cancer; Cancer or recurrent infection in the arm ; congenital lymph edema ; Patients who for other reasons such as trauma, burns, damage to lymph masses of the region have been affected by lymph edema.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
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,1 street Abyverdy, School of Rehabilitation Sciences, ShiraUniversity of Medical Sciences, Department of Physical Therapy ,Chamran Boulevard
City
Shiraz
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
ir.sums.rec.1394.167

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
pain
Timepoint
before treatment and after the tenth session
Method of measurement
numeric analog scale (NAS)

2

Description
swelling
Timepoint
before treatment and after the tenth session
Method of measurement
difference in volume between the two sides in various locations and measuring the difference between the volumes of fluid displacement

3

Description
function
Timepoint
before treatment and after the tenth session
Method of measurement
DASH questionnaires (Disability of Arm Shoulder Hand)

Secondary outcomes

empty

Intervention groups

1

Description
The first group receive conventional therapy (complex decongestive therapy) which includes four stages: gentle massage for lymph drainage, compression therapy with bandages, skin care and exercise.
Category
Treatment - Other

2

Description
The second group, in addition to conventional therapy, receive ultrasound therapy with the intensity of 2 Watt / cm2 and with the frequency of 1 MHz in the arm, forearm and hand.
Category
Other

3

Description
The third group, in addition to conventional therapy, receive faradic under pressure flow. (frequency 30 Hz, pulse width 300 microsecond, hold time 2 s, rest time 5 s,10 min on the flexors muscle of forearm and 10 min on the extensors muscle of forearm)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
center of lymphedema motahari clinic
Full name of responsible person
Zahra Rojhani Shirazi
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Shiraz Faculty of Rehabilitation, Chamran blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Zahra Rojhani Shirazi
Position
PhD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation, Chamran blvd.
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PhD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation, Chamran blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
PhD
Other areas of specialty/work
Street address
Shiraz Faculty of Rehabilitation,Chamran blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
rojhaniz@sums.ac.ir
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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