Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.

NCT06230913 | Completed DMC

• 1 other identifier: RHPT/023/01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema of Upper Arm; Burns Chest Right Lateral; Burns Chest Left Lateral

Keywords

Kinesiotaping; Pressure garments; Lymphedema; Chest burns; Breast reconstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Functional disability - SPADI

  Baseline

• Functional disability - SPADI

  2 months

• Functional disability - SPADI

  6 months

• Functional disability - SPADI

  12 months

• Handgrip strength

  Baseline

Study Arms (2)

Kinesiotaping group

EXPERIMENTAL

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

Pressure garment group

ACTIVE COMPARATOR

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

Interventions

Kinesiotape DEVICE

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.

Kinesiotaping group

Pressure garment DEVICE

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.

Pressure garment group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Microsurgical breast reconstruction after severe chest burns.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Conditions that resulted in oedema or swelling,
• medication like diuretics,
• infections,
• allergies,
• other systemic diseases,
• pregnancy,
• bilateral lymphadenitis

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 30, 2024
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)