- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01657149
Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement
Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement - Randomized Control Trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In the past few decades there has been a rise in the number of knee replacements performed due to degenerative arthritis. In general over the years the number of operations has risen while the age of the patients has gone down. The aim of these operations is to improve quality of life, alleviate pain and improve function.
Post operative complications can delay recovery and rehabilitation, lengthen hospitalization duration and in extreme cases lead to failure of the operation. These complications include infection, deep vein thrombosis, swelling and edema, pain, impairment of range of motion, muscle weakness and functional disability.
Reduction of post operative edema may help to speed up recovery after total knee replacement.
Recently an effective treatment has been found for lymphatic edema that appears after oncological operations that include removal of lymph nodes or due to blood vessel disorders. This treatment is administered by a physiotherapist and includes lymphatic drainage massage, compression bandaging and exercises.
This trial will examine the effect of lymphatic massage treatment on orthopedic patients to ascertain if the use of this technique can shorten the duration and improve the quality of the post operative rehabilitation and prevent other post operative complications. At the present time not enough research has been done in this field and it is necessary to continue to investigate the efficiency of the lymphatic treatment in acute orthopedic patients.
Aims To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.
Methods This blind randomized trial will take place in the Sharon hospital in Petach Tikvah with the cooperation of the orthopedic surgeons. The patients will be randomized into two groups- each containing 15 patients. The research group will receive lymphatic massage and individual physiotherapy while the control group will receive individual physiotherapy only.
Methods In order to assess the effects of the treatment the primary measurement will be circumferential measurement of limb volume. The secondary measurements will be pain assessment according to the VAS scale, a functional assessment according to BI"TI and range of motion measured with an inclinometer .
The measurements will be taken once prior to hospitalization. During hospitalization the measurements will be taken daily including the day of the release home and one last measurement will be taken 6 weeks after the operation. All measurements are valid and reliable.
The trial is scheduled to last 3-4 months
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Petah Tiqva, Israël
- Rabin Medical Center, Campus Golda
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- primary total knee replacement
- ages 50-85
- preserved cognitive facilities and comprehension.
Exclusion Criteria:
- Severe chronic heart failure.
- previous episode of lymph edema.
- surgical removal of lymph nodes in the lower limbs.
- significant scarring of the lower limbs (larger than 10 cm).
- Deterioration in a patient's medical condition or an infection of the lower limb during the trial period will also cause exclusion of that patient.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Research Group
receive lymphatic massage and individual physiotherapy
|
lymphatic massage and individual physiotherapy
|
|
Comparateur actif: Control group
receive individual physiotherapy only
|
individual physiotherapy only
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Circumferential measurement of limb volume
Délai: The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op
|
The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Visual Analogue Scale (VAS) Inclinometer
Délai: VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op
|
VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op
|
|
Daily functional capacity Assessment
Délai: Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op
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Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 0081-12-RMC
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