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Investigating the effect of manual lymph drainage and exercise in patients with lymphedema

Protocol summary

Study aim
Investigating the effect of manual lymph drainage of exercise in patients with lymphedema
Design
Clinical trial with control group, with parallel groups, non-randomized, on 130 patients. A non-random method was used to divide the groups into control and intervention groups.
Settings and conduct
First, patients with lymphedema are referred to Mubasher Hamedan Clinic by oncology and radiotherapy specialists, and they are included in the study if they meet the eligibility criteria. People are placed in two groups of manual lymphatic drainage and exercise randomly; first, in each group, the variables of limb volume, pain, quality of life, and range of motion of the shoulder are evaluated and investigated, then in the manual lymphatic drainage group, the lymphatic pathways involved and certain are drained by massage and these pathways and lymph nodes are used to change the path of lymph fluid rich in protein from the organ or the swollen part of the body to the venous system, and in the exercise group, a series of exercises It is given to the patient according to the research done and at the end the variables are re-evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria: people with lymphedema, women aged 25-68 Non-entry conditions: existence of disease problems, existence of aortic aneurysm
Intervention groups
The intervention group includes patients with lymphedema who receive manual lymphatic drainage. The comparison group includes patients with lymphedema who receive the exercise therapy protocol.
Main outcome variables
Including evaluation of the organ environment through tape measure, evaluation of pain score using numerical rating scale, and evaluation of functional disability level through questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160704028776N2
Registration date: 2025-01-14, 1403/10/25
Registration timing: prospective

Last update: 2025-01-14, 1403/10/25
Update count: 0
Registration date
2025-01-14, 1403/10/25
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77548496
Email address
roosta@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-19, 1403/10/30
Expected recruitment end date
2025-08-16, 1404/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of manual lymph drainage and exercise in patients with lymphedema
Public title
The effect of manual lymph drainage and exercise
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with lymphedema who have been referred to the physiotherapy clinic by radiotherapy and oncology specialists Women aged 25 to 65 years No heart problems Absence of aortic aneurysm Absence of any musculoskeletal-neurological disorder that is not related to the complications of cancer Absence of autoimmune diseases such as rheumatoid arthritis
Exclusion criteria:
The patient's lack of consent to cooperate at any stage of the research
Age
From 25 years old to 68 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Not 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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.055

Health conditions studied

1

Description of health condition studied
Lymphedema
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphedema syndrome

Primary outcomes

1

Description
Organ volume: measuring the circumference of the limb with lymphedema
Timepoint
Before and after the intervention during the same session
Method of measurement
A standard tape measure tool was used to measure manual lymphatic drainage.

Secondary outcomes

1

Description
Pain: score from 1 to 10 based on VAS scale
Timepoint
Before and after the intervention during the same session
Method of measurement
The measurement was done with a tape measure.

2

Description
Quality of life: checking people's quality of life using the score of the quality of life questionnaire
Timepoint
Before and after the intervention during the same session
Method of measurement
By evaluating the score of the quality of life questionnaire of the World Health Organization

3

Description
Shoulder range of motion: the degree of shoulder elevation angle
Timepoint
Before and after the intervention during the same session
Method of measurement
The movement angle of the shoulder is measured using a goniometer

Intervention groups

1

Description
Manual lymph drainage group: In this study, one session of manual lymph drainage lasts for 2-3 hours, the most important part of manual lymph drainage is to identify the areas that need to be drained and also to identify healthy and necessary lymphatic pathways. These pathways and lymph nodes are used to change the path of protein-rich lymph fluid from the organ or the swollen part of the body to the venous system. The basis of the technique of manual lymph drainage is the basic strokes, which are: Rotary, pump, stationary circle, scoop. The common feature of all four techniques is having two phases, including the working or pressing phase and the rest or relaxing phase. All of these techniques are applied from the center to the periphery, in such a way that first the proximal areas are drained in order to prepare for the liquid collected in the distal parts. In the working phase of each stroke, the stimuli A stretch is applied to the subcutaneous tissue. The pressure in this phase should be so much that it causes the subcutaneous tissue to stretch on the underlying fascia to the extent of its elastic capacity. Applying gentle and directional pressure during the work phase causes the movement of lymph fluid in the right direction and causes the lymph to drain in the desired direction. The best result is achieved when each work phase lasts one second and 5 to 7 times at each point in a fixed pattern. Or a varied pattern is repeated.
Category
Rehabilitation

2

Description
Intervention group: exercise: In this study, patients exercise for one session and for a duration of 30 minutes according to the therapeutic exercise protocol. The patients' exercise protocol includes diaphragmatic breathing, stretching exercises of the upper limbs, including stretching of the flexor and extensor muscles of the arm and wrist; The patient keeps each stretching exercise for 15-30 seconds and repeats two sets of three. While performing diaphragmatic breathing, the patient's position is such that the patient's fingers are placed in front of the sternum and the patient starts performing diaphragmatic breathing. When performing exercises, compression bandages or compression bandages should be used. Tight and restrictive clothes should not be used during exercise. Movements should be slow and controlled.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Facu
Full name of responsible person
Dr. Mohammad Mohsen Roostae
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
roosta@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohsen Roostayi
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
roosta@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohsen Roostae
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehranر
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
roosta@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohsen Roostae
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
roosta@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohsen Roostae
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Imam Hossein Square, Damavand Street (New Tehran), Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
roosta@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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