A Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
Ключови думи
Резюме
Дати
Последна проверка: | 01/31/2018 |
Първо изпратено: | 06/23/2010 |
Очаквано записване подадено: | 06/27/2010 |
Първо публикувано: | 06/28/2010 |
Изпратена последна актуализация: | 02/25/2018 |
Последна актуализация публикувана: | 02/26/2018 |
Действителна начална дата на проучването: | 09/10/2007 |
Приблизителна дата на първично завършване: | 04/23/2017 |
Очаквана дата на завършване на проучването: | 04/23/2017 |
Състояние или заболяване
Интервенция / лечение
Other: GroupA
Other: GroupB
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Active Comparator: GroupA Ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. Multilayer bandage is applied daily during the first four weeks.
The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied. | Other: GroupA Group A or Control Group: ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied. |
Experimental: GroupB Ambulatory treatment is carried out during one month. Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. | Other: GroupB Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | Female |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - women older than 18 years, intervented of unilateral breast neoplasia with ipsilateral axillar lymphadenectomy - Patients with ipsilateral lymphoedema with a volume difference of at least 200ml compared to the lateral limb - Patients who have finished the treatment with Radiotherapy and / or chemotherapy at least six months before the study started - Informed acceptance has to be signed Exclusion Criteria: - Bilateral affectation of both extremities. - Malignant Active disease - Acute Lymphoedema (in the first three months postintervention) - Patients with previous paralysis or vascular alteration in the affected arm - Patients with a major limitation of 30 º in any of the arches of movement of the ipsilateral shoulder - Patients with contraindication for Lymphatic Manual Drainage (cellulite, deep venous thrombosis, heart failure, not controlled hypertension, renal failure and important radiodermatitis) - Patients who have been managed with treatment of rehabilitation in three months previous to the recruitment. |
Резултат
Първични изходни мерки
1. Statistical analysis [1 year after the clinical trial ends]
Вторични изходни мерки
1. Statistical analysis [1 year after the clinical trial ends]