Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01748604
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-12-06
Brief Title:
Physical Therapies in the Decongestive Treatment of Lymphedema
Sponsor:
Isabel Forner-Cordero MD PhD
Organization:
Hospital Universitario La Fe
Study Overview
Official Title:
Physical Therapies in the Decongestive Treatment of Lymphedema A Multicenter Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this multicenter randomised controlled study is to determine whether manual lymphatic drainage MLD brings any benefit when added to intermittent pneumatic compression IPC plus multilayer multicomponent bandages MB in the decongestive lymphatic therapy DLT in patients with lymphedema
Detailed Description:
Study Design the study was a multicenter randomized controlled study conducted at three university hospitals in Spain Potential subjects were identified at Rehabilitation Department where physicians were responsible for screening subjects for eligibility and enrolling into the study
Patients that fulfilled the inclusion criteria and signed up the informed consent were stratified within 2 stratums upper and lower limb lymphedema and then were randomized to one of the three treatment groups
The type of randomization was a total randomization with ratio 111 and the method used to generate the random allocation sequence was a computer-generated random numbers table Adequate randomization includes calling a central office once eligibility has been determined
The physicians that assessed the outcome and the statistic who analyzed de data were blinded to the subjects treatment assignment
The study was approved by the Research Ethics Committee of the University Hospital La Fe It was conducted according to the ethical principles laid down in the declaration of Helsinki 52nd World Medical Association General Assembly Edinburgh Scotland October 2000 and the rules of best clinical practice
Treatment Regimens Patients were randomized to one of the following treatment groups
Group A or control group Manual Lymphatic Drainage MLD with Földis technique by an expert therapist during 45 minutes intermittent pneumatic compression IPC with multicompartmental pump between 50 to 80 mmHg during 30 minutes followed by multilayer multicomponent bandages MB until next day
Group B Pneumatic massage with Lymphapress-PlusTM device that was lent during the duration of the study during 20 minutes and was supposed to open the proximal lymphatics at the root of the limb IPC 50 to 80 mmHg during 30 minutes followed by MB until next day
Group C IPC 50 to 80 mmHg during 30 minutes followed by MB until next day
All patients were planned to receive 20 sessions of treatment 5 per week in consecutive days during 4 consecutive weeks and were trained in skin care and daily exercises
After DLT garments were prescribed and their adaptation was checked to warrant the maintenance of the results The garments were flat knitted custom made generally class 2 18-21 mmHg for upper limb and class 3 36-46 mmHg for lower limb
Sample Size and Statistical analyses This trial compares the efficacy of two treatment modalities without MLD experimental group B and C with a standard trimodal therapy control group A The expected effect size in percentage reduction in excess volume PREV primary end point for the control group MLDIPCMB was defined from the review of literature and was 50 to 70 mean 60 with a standard deviation of 20 to 30 mean 25 Our hypothesis was that there are no differences between experimental and standard treatment
The required sample size for the study was 177 patients or 59 subjects per group to detect differences greater than or equal 15 in the percentage reduction in excess volume PREV between control and experimental groups if exists considering differences less than 15 as not clinically significant It was based on an alpha error of 5 and a power of 90 We estimated a drop-out rate of 10 Therefore 17 patients were added resulting in a sample size of 194 subjects
To compare baseline characteristics between three groups we use two-way ANOVA test for continuous variable and Pearsons chi2 for categorical data to detect potential confounding factors Outcome data were analyzed utilizing a two-way ANOVA test to assess differences between treatment groups with a 5 level of significance p005 and two-tailed tests
An exploratory subgroup analysis was made to identify factors associated with response PREV Factors for initial screening were identified by univariate linear regression model with a p value 01 In order to determine the independent predictive factors a multivariate linear regression analysis was applied
Patients that fulfilled the inclusion criteria and signed up the informed consent were stratified within 2 stratums upper and lower limb lymphedema and then were randomized to one of the three treatment groups
The type of randomization was a total randomization with ratio 111 and the method used to generate the random allocation sequence was a computer-generated random numbers table Adequate randomization includes calling a central office once eligibility has been determined
The physicians that assessed the outcome and the statistic who analyzed de data were blinded to the subjects treatment assignment
The study was approved by the Research Ethics Committee of the University Hospital La Fe It was conducted according to the ethical principles laid down in the declaration of Helsinki 52nd World Medical Association General Assembly Edinburgh Scotland October 2000 and the rules of best clinical practice
Treatment Regimens Patients were randomized to one of the following treatment groups
Group A or control group Manual Lymphatic Drainage MLD with Földis technique by an expert therapist during 45 minutes intermittent pneumatic compression IPC with multicompartmental pump between 50 to 80 mmHg during 30 minutes followed by multilayer multicomponent bandages MB until next day
Group B Pneumatic massage with Lymphapress-PlusTM device that was lent during the duration of the study during 20 minutes and was supposed to open the proximal lymphatics at the root of the limb IPC 50 to 80 mmHg during 30 minutes followed by MB until next day
Group C IPC 50 to 80 mmHg during 30 minutes followed by MB until next day
All patients were planned to receive 20 sessions of treatment 5 per week in consecutive days during 4 consecutive weeks and were trained in skin care and daily exercises
After DLT garments were prescribed and their adaptation was checked to warrant the maintenance of the results The garments were flat knitted custom made generally class 2 18-21 mmHg for upper limb and class 3 36-46 mmHg for lower limb
Sample Size and Statistical analyses This trial compares the efficacy of two treatment modalities without MLD experimental group B and C with a standard trimodal therapy control group A The expected effect size in percentage reduction in excess volume PREV primary end point for the control group MLDIPCMB was defined from the review of literature and was 50 to 70 mean 60 with a standard deviation of 20 to 30 mean 25 Our hypothesis was that there are no differences between experimental and standard treatment
The required sample size for the study was 177 patients or 59 subjects per group to detect differences greater than or equal 15 in the percentage reduction in excess volume PREV between control and experimental groups if exists considering differences less than 15 as not clinically significant It was based on an alpha error of 5 and a power of 90 We estimated a drop-out rate of 10 Therefore 17 patients were added resulting in a sample size of 194 subjects
To compare baseline characteristics between three groups we use two-way ANOVA test for continuous variable and Pearsons chi2 for categorical data to detect potential confounding factors Outcome data were analyzed utilizing a two-way ANOVA test to assess differences between treatment groups with a 5 level of significance p005 and two-tailed tests
An exploratory subgroup analysis was made to identify factors associated with response PREV Factors for initial screening were identified by univariate linear regression model with a p value 01 In order to determine the independent predictive factors a multivariate linear regression analysis was applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None