Clinical trial NCT06230913: Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.
Official title: Comparative Effects of Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema Following Microsurgical Breast Reconstruction After Severe Chest Burns.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Arm
Burns Chest Right Lateral
Burns Chest Left Lateral
Keywords: Kinesiotaping
Pressure garments
Lymphedema
Chest burns
Breast reconstruction
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 56
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arm circumference:
timeFrame: Baseline
measure: Arm circumference:
timeFrame: 2 months
measure: Arm circumference:
timeFrame: 6 months
measure: Arm circumference:
timeFrame: 12 months
Secondary outcomes:
measure: Functional disability - SPADI
timeFrame: Baseline
measure: Functional disability - SPADI
timeFrame: 2 months
measure: Functional disability - SPADI
timeFrame: 6 months
measure: Functional disability - SPADI
timeFrame: 12 months
measure: Handgrip strength
timeFrame: Baseline
measure: Handgrip strength
timeFrame: 2 months
measure: Handgrip strength
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 12 months
measure: QOL
timeFrame: Baseline
measure: QOL
timeFrame: 2 months
measure: QOL
timeFrame: 6 months
measure: QOL
timeFrame: 12 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Dr. Gopal Nambi
state: Riyadh
Study officials:
References: