Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.

Comparative Effects of Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema Following Microsurgical Breast Reconstruction After Severe Chest Burns.

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema of Upper Arm; Burns Chest Left Lateral; Burns Chest Right Lateral
• Intervention / Treatment: Device: Kinesiotape; Device: Pressure garment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia, 11942
      • Dr. Gopal Nambi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesiotaping group; 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.	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.
Active Comparator: Pressure garment group; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Lymphedema; Kinesiotaping; Breast reconstruction; Pressure garments; Chest burns
• Additional Relevant MeSH Terms: Lymphatic Diseases; Wounds and Injuries; Burns; Lymphedema
• Other Study ID Numbers: RHPT/023/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data can be obtained by contacting the primary author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No