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IRCT20230121057168N1 IRCT 2023-07-01 Mashhad University of Medical Sciences Comparing the effect of physiotherapy combined with manual lymphatic derenage massage with physiotherapy alone and manual lymphatic derenage massage alone on pain and volume of upper limb on breast cancer patients with lymphedema درمان ترکیبی فیزیوتراپی کامل اندام فوقانی و گردن به همراه ماساژ MLD Comparing the effect of physiotherapy combined with manual lymphatic derenage massage with physiotherapy alone and manual lymphatic derenage massage alone on pain and volume of upper limb on breast cancer patients with lymphedema: A randomized controlled trial study 2023-06-05 anticipated 84 Complete https://irct.ir/trial/68204 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization Patients are assigned to three groups to physiotherapy control group, massage control group, and PT+MLD intervention group using closed envelopes with block randomization method. In this way, it is divided into 6 states in 4 blocks. And each of these situations is randomly selected from the closed envelopes, and 4 people are assigned to the control and intervention groups based on the selected state of the closed envelope. The same process until the allocation of all participants in PT control groups, MLD massage control and PT+MLD intervention groups continue. 3 Lymphoedema. Intervention 1: Intervention group: Lymphatic drainage manual massage + physiotherapy In the intervention group of physiotherapy + MLD massage, patients are initially subjected to FES electrical stimulation for 20 minutes with an edema reduction program, in the next stage they undergo upper limb and neck physiotherapy treatment for 20 minutes, then to For 20 minutes, MLD massage will be performed on the affected upper limb and all lymph nodes. Physiotherapy in this group includes (3,17): First, the following exercises are performed for the patients in all sessions. and grade 1 and 2 mobilization for neck vertebrae, distraction, Inf glide, Pos glide shoulder in grade 1 and 2 distraction and mobilization of elbow and wrist in grade 1 and 2 Pumping in flexion and extension for fingers, wrist, elbow and shoulder exercises below In the third session, the patient is taught to do them under the supervision of the physiotherapist, then the patient is asked to continue the exercises at home on a daily basis. Diaphragmatic breathing exercise with expansion of the lungs and Outward ribs, abdomen and Lower back Ext while inhaling and exhaling with the nose and Inward ribs, abdomen and Lower back flexion, shoulder rotation movements with the help of a bar in full flexion, abduction and adduction, perform patterns Bilateral PNF along with trunk rotation, Upright position correction and postural exercises, Chin tuck, Shoulder shrug_Scapular retraction/adduction, resistance exercises including weight lifting with light weight for patients who are between one to three times in the direction of flexion and extension, abduction and adduction, internal rotation and external Do rotation for both elbow and shoulder joints (in case of ROM limitation, it will start with a low range and then it will progress). Resistance exercises will start with light weights, then heavier weights will be used. Also, in the advanced stages of the exercise, theraband with high elastic resistance will be used. After physiotherapy, MLD massage in the supine position on the sternum, neck, respectively. and the face, the underarm area of the opposite side, the underarm area of the affected side, and then transferring lymph from the underarm area of the affected side to the healthy side, and then massaging the groin on the healthy side and then the affected side, and transferring lymph from the underarm area of the affected side to the lymph nodes of the groin same side After these steps, the MLD massage is performed in a rotatory manner on the abdomen, then the patient is placed in a prone position and massage is performed from the affected armpit area to the healthy armpit area and massage from the armpit area of the affected lymph nodes to the batok area of the same side. is done After performing these steps, the patient is supine and MLD massage in the upper limb, respectively from the elbow area to the shoulder and armpit area, from the back of the wrist to the forearm, then from the back of the wrist to the shoulder, and in the next step, the wrist area to the Elbow and then from the wrist area towards the shoulder. All stages of Stroking massage are performed 15 times in each area. The duration of this massage will be about 20 minutes (12). Intervention 2: Control group: Physiotherapy In the physiotherapy control group, patients are initially subjected to FES electrical stimulation for 20 minutes with the edema reduction program, then according to the mentioned method, upper limb and neck physiotherapy will be performed for the patient for 20 minutes. Intervention 3: control group: In the control group of MLD massage, patients are initially subjected to FES electrical stimulation for 20 minutes with the edema reduction program, then MLD massage will be performed on the involved upper limb and all lymph nodes for 20 minutes according to the mentioned method. Yes - There is a plan to make this available What will be shared: Comparing the effect of physiotherapy combined with manual lymphatic derenage massage with physiotherapy alone and manual lymphatic derenage massage alone on pain and volume of upper limb on breast cancer patients with lymphedema: A randomized controlled trial study When: 06.12.2023 To whom: researchers Conditions: To investigate better treatment for lymphedema Where to obtain: Popmed database How to obtain: Article search Comments:
public Neda Mostafaee
Azadi Square, Mashhad University of Medical Sciences, Faculty of Paramedicine
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 neda_mostafaee@yahoo.com Mashhad University of Medical Sciences scientific Shima Eftekhar
Khayam Blv,Khayam 40,Ghavami18,Number 24
Mashhad Iran (Islamic Republic of) 9196744549 +98 51 3763 0685 shima37.eftekhar@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Female patients with lymphedema of at least 10% compared to healthy limb At least six months have passed since the patient's cancer treatment Having moderate physical activity in daily activities no limit no limit Female Active malignancy Recurrence of breast cancer high blood pressure Uncontrolled heart disease Patients with bilateral lymphedema venous insufficiency Low physical activity and inability to perform daily activities 197.2 Postmastectomy lymphoedema syndrome Rehabilitation Rehabilitation Rehabilitation Intervention group: Lymphatic drainage manual massage + physiotherapy In the intervention group of physiotherapy + MLD massage, patients are initially subjected to FES electrical stimulation for 20 minutes with an edema reduction program, in the next stage they undergo upper limb and neck physiotherapy treatment for 20 minutes, then to For 20 minutes, MLD massage will be performed on the affected upper limb and all lymph nodes. Physiotherapy in this group includes (3,17): First, the following exercises are performed for the patients in all sessions. and grade 1 and 2 mobilization for neck vertebrae, distraction, Inf glide, Pos glide shoulder in grade 1 and 2 distraction and mobilization of elbow and wrist in grade 1 and 2 Pumping in flexion and extension for fingers, wrist, elbow and shoulder exercises below In the third session, the patient is taught to do them under the supervision of the physiotherapist, then the patient is asked to continue the exercises at home on a daily basis. Diaphragmatic breathing exercise with expansion of the lungs and Outward ribs, abdomen and Lower back Ext while inhaling and exhaling with the nose and Inward ribs, abdomen and Lower back flexion, shoulder rotation movements with the help of a bar in full flexion, abduction and adduction, perform patterns Bilateral PNF along with trunk rotation, Upright position correction and postural exercises, Chin tuck, Shoulder shrug_Scapular retraction/adduction, resistance exercises including weight lifting with light weight for patients who are between one to three times in the direction of flexion and extension, abduction and adduction, internal rotation and external Do rotation for both elbow and shoulder joints (in case of ROM limitation, it will start with a low range and then it will progress). Resistance exercises will start with light weights, then heavier weights will be used. Also, in the advanced stages of the exercise, theraband with high elastic resistance will be used. After physiotherapy, MLD massage in the supine position on the sternum, neck, respectively. and the face, the underarm area of the opposite side, the underarm area of the affected side, and then transferring lymph from the underarm area of the affected side to the healthy side, and then massaging the groin on the healthy side and then the affected side, and transferring lymph from the underarm area of the affected side to the lymph nodes of the groin same side After these steps, the MLD massage is performed in a rotatory manner on the abdomen, then the patient is placed in a prone position and massage is performed from the affected armpit area to the healthy armpit area and massage from the armpit area of the affected lymph nodes to the batok area of the same side. is done After performing these steps, the patient is supine and MLD massage in the upper limb, respectively from the elbow area to the shoulder and armpit area, from the back of the wrist to the forearm, then from the back of the wrist to the shoulder, and in the next step, the wrist area to the Elbow and then from the wrist area towards the shoulder. All stages of Stroking massage are performed 15 times in each area. The duration of this massage will be about 20 minutes (12). Control group: Physiotherapy In the physiotherapy control group, patients are initially subjected to FES electrical stimulation for 20 minutes with the edema reduction program, then according to the mentioned method, upper limb and neck physiotherapy will be performed for the patient for 20 minutes. control group: In the control group of MLD massage, patients are initially subjected to FES electrical stimulation for 20 minutes with the edema reduction program, then MLD massage will be performed on the involved upper limb and all lymph nodes for 20 minutes according to the mentioned method. The pain of patients is evaluated with the NRS scale. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: The pain of patients is evaluated with questionnaire of the NRS scale. The size of the affected limb and the healthy limb will be measured. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: The circumference of the uper limb is measured using a tape measure. ROM of the upper limb joints is measured. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: The range of motion of the shoulder is measured using a goniometer. The performance of patients is evaluated. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: The performance of patients is evaluated using the Upper Limb Functional Index (ULFI) questionnaire. The degree of disability of the patients is evaluated. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: The degree of disability of the patients is evaluated with the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH). Quality of life of patients will be examined. Timepoint: Befor treatment After 15 sessions after 1 month. Method of measurement: Quality of life of patients will be examined using the Lymphedema Life Impact Scale (LLIS) questionnaire. Mashhad University of Medical Sciences Approved 2022-12-24 school of paramedian sciences and health school Yazdan building , Sadeghiyeh 18, sadeghiyeh bulv Mashhad Razavi Khorasan Iran (Islamic Republic of)