Comparison of the therapeutic effectiveness of telebiofeedback and conventional shoulder physiotherapy methods on improving the quality of life of breast cancer patients with a history of mastectomy
Investigating the effectiveness of shoulder telebiofeedback in improving the quality of life of mastectomy patients and then comparing new method with conventional physiotherapy to determine the best supportive treatment to be used in treatment and support centers.
Design
This study is a clinical trial type with a control group with parallel and randomized groups in three phases on 60 patients and Joule random numbers are used for randomization.
Settings and conduct
Eligible samples are selected from clinic patients of Rasool Akaram and Firoozgar hospital.The intervention group will undergo biofeedback therapy for 2 months, 2 sessions per week in the first month and one session per week in the second month and each session lasts 20 minutes. The control group will undergo physiotherapy with the same treatment plan.It is not possible to blind patients and therapists. The assessor is blinded in the assessment phase.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
• Women over 18 and under 65 with breast cancer who have undergone mastectomy.
Exclusion criteria;
• Metastatic patients
• Pregnancy
• History of trauma to the shoulder and neck area
• Cognitive disorders
• Radiation
• Leaving Tehran
• Death of patients
• The patient's unwillingness to intervene.
• Any previous dysfunction of the hands (burn, previous injury that causes dysfunction).
Intervention groups
Breast cancer patients who underwent mastectomy will be evaluated in the telebiofeedback intervention group and the effectiveness of physiotherapy in the control group.
Main outcome variables
quality of life in breast cancer patients with history of mastectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220814055691N1
Registration date:2022-10-09, 1401/07/17
Registration timing:registered_while_recruiting
Last update:2022-10-09, 1401/07/17
Update count:0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Mozhde Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
mohammadpour.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-05, 1401/06/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effectiveness of telebiofeedback and conventional shoulder physiotherapy methods on improving the quality of life of breast cancer patients with a history of mastectomy
Public title
tele biofeedback and shoulder physiotherapy effectiveness on the quality of life of breast cancer patients with a history of mastectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 18 and under 65 years old with breast cancer who have undergone radical mastectomy modification.
Exclusion criteria:
metastatic cancer
pregnancy
history of trauma to neck and upper limb
cognition impairment
radiation
leaving Tehran
Death
reluctance to intervention
any previous dysfunction in shoulder function
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be simple, which is done by the random numbers table method
The table of random numbers is a set of numbers without a specific pattern and order, which is determined to read the numbers first, and in this study, even numbers will be telebiofeedback and odd numbers will be physiotherapy.
Due to the fact that the sampling is done in a multi-centered manner, the method of concealment is done centrally, and the participants' entry into the study is done by phone call to the Firuzgar center.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were evaluated by a separate researcher who did not participate in the selection and treatment of patients and was blind to the procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Iran University of Medical Sciences.
The intervention is measured in weeks 0, 4, and 12 after intervention
Method of measurement
Based on Quality of Life Questionnaire-Core 30 (QLQC30) questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group (telebiofeedback) which is a specific type of physiotherapy for the shoulder joint and muscles in which the surface electrodes are placed on the patient's skin in specific areas and record the electrical activity of certain muscles based on the location. Patients are first trained on how to use the device, These people will be given the necessary explanations on how to communicate with the doctor/therapist. For 2 months, 2 sessions per week in the first month and 1 session per week in the second month and each session for 20 minutes underwent shoulder muscle biofeedback therapy to strengthen weakened muscles And the necessary muscle relaxation is based on the initial assessment and established protocols. In these sessions, the doctor/therapist is present online And according to the access to the biofeedback program and the results obtained from it, it controls and reviews the sports. During the sessions, the therapist determines the intensity and frequency of the exercises that the patient should do according to the progress of the patient and the frequent evaluations he performs before, during and after the session.
Category
Rehabilitation
2
Description
Control group: In the control group, patients are subjected to conventional shoulder physiotherapy for 2 months, 2 sessions per week in the first month and one session per week in the second month, and each session lasts 20 minutes, based on the mentioned protocols. In the control group, the same patients for 2 months, 2 sessions per week in the first month and one session per week in the second month and each session for 20 minutes under conventional shoulder physiotherapy which includes electrical stimulation methods, infrared rays and ultrasound and training Sports will be included. In both cases, due to the nature of sports, the patient will not be deprived of the minimum necessary measures and will not cause a disturbance in the patient's recovery process.