Trial Outcomes & Findings for Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema (NCT NCT03765996)
NCT ID: NCT03765996
Last Updated: 2020-05-06
Results Overview
Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
At baseline and at 4 weeks
Results posted on
2020-05-06
Participant Flow
Patients enrolled in the study between 2012 and 2014.
Participant milestones
| Measure |
Decongestive Physiotherapy
This group received Complex Decongestive Physiotherapy.
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
|
Decongestive Physiotherapy Plus Taping
This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
14
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Four patients in control group excluded from the study due to not completed the study
Baseline characteristics by cohort
| Measure |
Decongestive Physiotherapy
n=18 Participants
This group received Complex Decongestive Physiotherapy.
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
|
Decongestive Physiotherapy Plus Taping
n=18 Participants
This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.42 years
STANDARD_DEVIATION 7.69 • n=18 Participants
|
58.44 years
STANDARD_DEVIATION 10.12 • n=18 Participants
|
56.25 years
STANDARD_DEVIATION 9.34 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants • Four patients in control group excluded from the study due to not completed the study
|
18 Participants
n=18 Participants • Four patients in control group excluded from the study due to not completed the study
|
32 Participants
n=32 Participants • Four patients in control group excluded from the study due to not completed the study
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants • Four patients in control group excluded from the study due to not completed the study
|
0 Participants
n=18 Participants • Four patients in control group excluded from the study due to not completed the study
|
0 Participants
n=32 Participants • Four patients in control group excluded from the study due to not completed the study
|
|
Region of Enrollment
Turkey
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: At baseline and at 4 weeksLimb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).
Outcome measures
| Measure |
Decongestive Physiotherapy
n=14 Participants
This group received Complex Decongestive Physiotherapy.
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
|
Decongestive Physiotherapy Plus Taping
n=18 Participants
This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
|
|---|---|---|
|
Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)
|
160.01 milliliter
Interval 81.5 to 650.56
|
148.28 milliliter
Interval 52.29 to 552.85
|
Adverse Events
Decongestive Physiotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Decongestive Physiotherapy Plus Taping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ertan Şahinoğlu
Dr. İsmail Atabek Physiotherapy and Rehabilitation Center
Phone: +90 532 647 86 53
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place