Lymphedema of Upper ArmNCT06230913
Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema.
A study testing Kinesiotape and Pressure garment in people with Lymphedema of Upper Arm and Burns Chest Right Lateral, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Lymphedema of Upper Arm, Burns Chest Right Lateral, Burns Chest Left Lateral
- What is being tested?
- Kinesiotape and Pressure garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Conditions that resulted in oedema or swelling,
- medication like diuretics,
- infections,
- allergies,
- other systemic diseases,
- pregnancy,
- bilateral lymphadenitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Kinesiotape, Pressure garment
- Keywords
- Kinesiotaping, Pressure garments, Lymphedema, Chest burns, Breast reconstruction
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
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 garmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pressure garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 12 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230913
- Sponsor's protocol ID
- RHPT/023/01
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data can be obtained by contacting the primary author.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kinesiotaping Versus Pressure Garments on Secondary Upper Extremity Lymphedema Following Microsurgical Breast Reconstruction After Severe Chest Burns.
- ClinicalTrials.gov ID
- NCT06230913
- Acronym / sponsor ID
- RHPT/023/01
- Keywords
- Kinesiotaping, Pressure garments, Lymphedema, Chest burns, Breast reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping group | Experimental | Device: KinesiotapeTo 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 group | Active comparator | Device: Pressure garmentThe 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Conditions that resulted in oedema or swelling,
- medication like diuretics,
- infections,
- allergies,
- other systemic diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapeTo 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 | Kinesiotaping group |
| Pressure garmentThe 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 group |
Primary outcome
Arm circumference:
Time frame: Baseline
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"
Arm circumference:
Time frame: 2 months
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"
Arm circumference:
Time frame: 6 months
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"
Arm circumference:
Time frame: 12 months
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 secondary outcomes
Functional disability - SPADI
Time frame: Baseline
Functional disability - SPADI
Time frame: 2 months
Functional disability - SPADI
Time frame: 6 months
Functional disability - SPADI
Time frame: 12 months
Handgrip strength
Time frame: Baseline
Handgrip strength
Time frame: 2 months
Handgrip strength
Time frame: 6 months
Handgrip strength
Time frame: 12 months
QOL
Time frame: Baseline
QOL
Time frame: 2 months
QOL
Time frame: 6 months
QOL
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Yes. The individual participant data can be obtained by contacting the primary author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and Pressure garment in people with Lymphedema of Upper Arm and Burns Chest Right Lateral, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm circumference: (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.