Back to resultsExtracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
Primary Purpose
Axillary Web Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low-energy extracorporeal shockwave and a tailored exercise program
low-energy extracorporeal shockwave
tailored exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Web Syndrome focused on measuring axillary web syndrome, shock wave, exercises, breast cancer surgery
Eligibility Criteria
Inclusion Criteria: female between the ages of 40 and 65 years Exclusion Criteria: metastases of any kind lymphedema, a traumatic injury to the targeted upper extremity a musculoskeletal disorder taking any anticoagulants had undergone bilateral breast cancer surgery experienced locoregional recurrence had vascular problems in the affected upper extremity
Sites / Locations
- Hany Mohamed ElgoharyRecruiting
- MohamedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
low-energy extracorporeal shockwave and a tailored exercise program
low-energy extracorporeal shockwave
tailored exercise program
Arm Description
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range. in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises. a combination of all these types of exercises will be used. Repeat these exercises 5 times, with 3 repetitions done each day for four consecutive weeks.
Outcomes
Primary Outcome Measures
digital inclinometer
digital inclinometer will be used for the assessment of the shoulder range of motion. The inclinometer is placed near the shoulder at the proximal area with the patient's feet fixed, and the patients then moves their shoulder in different directions (flexion and abduction). The examiner repeats the measurements three times and takes the mean value as the proven measurement.
Secondary Outcome Measures
visual analogue scale
the visual analog scale will be used for the assessment of pain intensity. It is a 100mm horizontal continuous line that begins on the left side with no pain and ends on the right side with more pain. The visual analogue point that corresponds to the patient's level of pain was asked to be marked by the patients. The researcher determines a score between 0 and 100 mm by measuring the distance (mm) on the 10 cm line between the patient's mark and the "no pain" sign at the left side end
Quick DASH score
the Quick DASH will be used for the assessment of upper limb disability by using shoulder and hand functions. the Arabic version of the Shortened Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH) is a reliable and valid measure for assessing disabilities in the upper extremities of Arabic-speaking populations. Its Cronbach's alpha of 0.89 indicates good internal consistency, while its ICC of 0.94 suggests that it has good test-retest reliability
Ultrasonography
this device will be used for the assessment of axillary cord thickness, echogenecity and disorganization. One technique used in ultrasonography is utilizing a high-resolution ultrasound system with 18 MHz frequency, which provides high-definition superficial imaging. A gel technique is also used to reduce artifacts caused by tissue compression. This technique can be used to measure cord thickness, echogenicity, and disorganization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05920369
Brief Title
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
Official Title
The Combined Effect of Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome After Breast Cancer Surgery With Axillary Dissection: A Comparative, Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.
Detailed Description
Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Web Syndrome
Keywords
axillary web syndrome, shock wave, exercises, breast cancer surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
controlled, double-blinded, randomized clinical trial, three arms
Masking
ParticipantOutcomes Assessor
Masking Description
a well-experienced outcome assessor and participants are blind to the assignment of groups.
Allocation
Randomized
Enrollment
93 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low-energy extracorporeal shockwave and a tailored exercise program
Arm Type
Experimental
Arm Description
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
Arm Title
low-energy extracorporeal shockwave
Arm Type
Active Comparator
Arm Description
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
Arm Title
tailored exercise program
Arm Type
Active Comparator
Arm Description
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises. a combination of all these types of exercises will be used. Repeat these exercises 5 times, with 3 repetitions done each day for four consecutive weeks.
Intervention Type
Other
Intervention Name(s)
low-energy extracorporeal shockwave and a tailored exercise program
Other Intervention Name(s)
ESWTTEP
Intervention Description
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm.
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
Intervention Type
Other
Intervention Name(s)
low-energy extracorporeal shockwave
Other Intervention Name(s)
ESWT
Intervention Description
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm.
Intervention Type
Other
Intervention Name(s)
tailored exercise program
Other Intervention Name(s)
TEP
Intervention Description
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
Primary Outcome Measure Information:
Title
digital inclinometer
Description
digital inclinometer will be used for the assessment of the shoulder range of motion. The inclinometer is placed near the shoulder at the proximal area with the patient's feet fixed, and the patients then moves their shoulder in different directions (flexion and abduction). The examiner repeats the measurements three times and takes the mean value as the proven measurement.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
visual analogue scale
Description
the visual analog scale will be used for the assessment of pain intensity. It is a 100mm horizontal continuous line that begins on the left side with no pain and ends on the right side with more pain. The visual analogue point that corresponds to the patient's level of pain was asked to be marked by the patients. The researcher determines a score between 0 and 100 mm by measuring the distance (mm) on the 10 cm line between the patient's mark and the "no pain" sign at the left side end
Time Frame
4 weeks
Title
Quick DASH score
Description
the Quick DASH will be used for the assessment of upper limb disability by using shoulder and hand functions. the Arabic version of the Shortened Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH) is a reliable and valid measure for assessing disabilities in the upper extremities of Arabic-speaking populations. Its Cronbach's alpha of 0.89 indicates good internal consistency, while its ICC of 0.94 suggests that it has good test-retest reliability
Time Frame
4 weeks
Title
Ultrasonography
Description
this device will be used for the assessment of axillary cord thickness, echogenecity and disorganization. One technique used in ultrasonography is utilizing a high-resolution ultrasound system with 18 MHz frequency, which provides high-definition superficial imaging. A gel technique is also used to reduce artifacts caused by tissue compression. This technique can be used to measure cord thickness, echogenicity, and disorganization
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female
between the ages of 40 and 65 years
Exclusion Criteria:
metastases of any kind
lymphedema,
a traumatic injury to the targeted upper extremity
a musculoskeletal disorder
taking any anticoagulants
had undergone bilateral breast cancer surgery
experienced locoregional recurrence
had vascular problems in the affected upper extremity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M Elgohary, PHD
Phone
00201093182291
Email
hmielgohary@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rehan G Adelnaser, PHD
Phone
00201220269787
Email
Dr.rehan.gamal@gmail.com
Facility Information:
Facility Name
Hany Mohamed Elgohary
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Elgohary, PhD
Phone
0590997821
Email
gohary75pt@hotmail.com
Facility Name
Mohamed
City
Cairo
ZIP/Postal Code
P.O.Box 11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr A Abouzeid, PH.D
Phone
00201006134539
Email
amrahmedabouzid@mans.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
results
Citations:
PubMed Identifier
31435359
Citation
Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.
Results Reference
background
Learn more about this trial
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
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