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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06230913
Other study ID # RHPT/023/01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 30, 2023

Study information

Verified date January 2024
Source Prince Sattam Bin Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomised control study is to compare kinesiotaping and pressue garments in secondary upper extremity lymphedema following microsurgical breast reconstruction after severe chest burns. The primary objective of this study was to compare the effects of kinesiotaping and pressure garments on limb circumference, handgrip strength, shoulder pain and disability index (SPADI), and limb circumference in patients with lymphedema following breast reconstruction due to chest burns. The participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28). To perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. Five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side. In the pressure garment group, the participant's skin was washed and dried before applying the PG. The Premium Lymphedema Gradient Garment (Jobskin, Long Eaton, England) was used to apply PGs. This garment has a pressure gradient built into it, applying between 20 and 60 mm Hg for at least 15 to 18 hours each day for three weeks.


Description:

The participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28). To perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. Five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side. In the pressure garment group, the participant's skin was washed and dried before applying the PG. The Premium Lymphedema Gradient Garment (Jobskin, Long Eaton, England) was used to apply PGs. This garment has a pressure gradient built into it, applying between 20 and 60 mm Hg for at least 15 to 18 hours each day for three weeks.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date October 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Microsurgical breast reconstruction after severe chest burns. - the patient's arm circumference should be at least more than 2cm but not greater than 8 cm when compared to the same site on the opposite arm. Exclusion Criteria: - Conditions that resulted in oedema or swelling, - medication like diuretics, - infections, - allergies, - other systemic diseases, - pregnancy, - bilateral lymphadenitis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesiotape
To perform taping of the chest, the patient was asked to stand upright with the affected shoulder rotated externally. Five straps of the fan shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side.
Pressure garment
The skin was washed and dried before applying the PG. The Premium Lymphedema Gradient Garment (Jobskin, Long Eaton, England) was used to apply PGs. This garment has a pressure gradient built into it, applying between 20 and 60 mm Hg for at least 15 to 18 hours each day for three weeks. The gradient counter pressure is applied using a gram tension.

Locations

Country Name City State
Saudi Arabia Dr. Gopal Nambi Al Kharj Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arm circumference: To measure the arm circumference, the patient lays in a prone position with their arms relaxed by the side of the body. A measuring tape is used to take the measurement. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and midhand. For an accurate reading, the tape was snugly wrapped around the arm. The measurements were recorded for both the affected and unaffected arms, and the difference between the two measurements was then recorded under the title "circumference difference" Baseline
Primary Arm circumference: To measure the arm circumference, the patient lays in a prone position with their arms relaxed by the side of the body. A measuring tape is used to take the measurement. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and midhand. For an accurate reading, the tape was snugly wrapped around the arm. The measurements were recorded for both the affected and unaffected arms, and the difference between the two measurements was then recorded under the title "circumference difference" 2 months
Primary Arm circumference: To measure the arm circumference, the patient lays in a prone position with their arms relaxed by the side of the body. A measuring tape is used to take the measurement. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and midhand. For an accurate reading, the tape was snugly wrapped around the arm. The measurements were recorded for both the affected and unaffected arms, and the difference between the two measurements was then recorded under the title "circumference difference" 6 months
Primary Arm circumference: To measure the arm circumference, the patient lays in a prone position with their arms relaxed by the side of the body. A measuring tape is used to take the measurement. It was measured starting with 3 cm on the ulnar styloid process and proceeding with 45 cm proximal, and additionally at the metacarpal bones and midhand. For an accurate reading, the tape was snugly wrapped around the arm. The measurements were recorded for both the affected and unaffected arms, and the difference between the two measurements was then recorded under the title "circumference difference" 12 months
Secondary Functional disability - SPADI It is a tool to measure shoulder pain and disability. It consists of 13 criterias to assess pain and disabilty: 5 criterias assess pain and 8 assess disability. The reliability of its coefficients is ICC =0.89 and has shown high internal consistency. Baseline
Secondary Functional disability - SPADI It is a tool to measure shoulder pain and disability. It consists of 13 criterias to assess pain and disabilty: 5 criterias assess pain and 8 assess disability. The reliability of its coefficients is ICC =0.89 and has shown high internal consistency. 2 months
Secondary Functional disability - SPADI It is a tool to measure shoulder pain and disability. It consists of 13 criterias to assess pain and disabilty: 5 criterias assess pain and 8 assess disability. The reliability of its coefficients is ICC =0.89 and has shown high internal consistency. 6 months
Secondary Functional disability - SPADI It is a tool to measure shoulder pain and disability. It consists of 13 criterias to assess pain and disabilty: 5 criterias assess pain and 8 assess disability. The reliability of its coefficients is ICC =0.89 and has shown high internal consistency. 12 months
Secondary Handgrip strength a handheld dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, England) was used to measure the hand grip strength. To record the hand grip strength, the patient is positioned in the standing position with their shoulder adducted, elbows flexed at an angle of 90 degrees with the forearm in mid position. The patient is asked to grip the device to the maximum of his capacity, the average of 3 readings are recorded. Baseline
Secondary Handgrip strength a handheld dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, England) was used to measure the hand grip strength. To record the hand grip strength, the patient is positioned in the standing position with their shoulder adducted, elbows flexed at an angle of 90 degrees with the forearm in mid position. The patient is asked to grip the device to the maximum of his capacity, the average of 3 readings are recorded. 2 months
Secondary Handgrip strength a handheld dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, England) was used to measure the hand grip strength. To record the hand grip strength, the patient is positioned in the standing position with their shoulder adducted, elbows flexed at an angle of 90 degrees with the forearm in mid position. The patient is asked to grip the device to the maximum of his capacity, the average of 3 readings are recorded. 6 months
Secondary Handgrip strength a handheld dynamometer (78010, Lafayette Instrument Company, Loughboroug, Leics, England) was used to measure the hand grip strength. To record the hand grip strength, the patient is positioned in the standing position with their shoulder adducted, elbows flexed at an angle of 90 degrees with the forearm in mid position. The patient is asked to grip the device to the maximum of his capacity, the average of 3 readings are recorded. 12 months
Secondary QOL The was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition. Baseline
Secondary QOL The was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition. 2 months
Secondary QOL The was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition. 6 months
Secondary QOL The was assessed by cancer-specific questionnaire (EORTC QLQ-C30). It is composed of 30 questions, including functional scores (physical, social, emotional, and cognitive aspects). The functional scores ranged between 0 and 100, and higher scores indicated better condition. This questionnaire also included symptoms score (pain, dyspnea, fatigue, insomnia, nausea, loss of appetite, and financial problems). The symptom scores ranged from 100 to 0, and lower scores indicated better condition. 12 months
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