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Trial Title:
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
NCT ID:
NCT05920369
Condition:
Axillary Web Syndrome
Conditions: Official terms:
Syndrome
Conditions: Keywords:
axillary web syndrome
shock wave
exercises
breast cancer surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
controlled, double-blinded, randomized clinical trial, three arms
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
a well-experienced outcome assessor and participants are blind to the assignment of
groups.
Intervention:
Intervention type:
Other
Intervention name:
low-energy extracorporeal shockwave and a tailored exercise program
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
Arm group label:
low-energy extracorporeal shockwave and a tailored exercise program
Other name:
ESWTTEP
Intervention type:
Other
Intervention name:
low-energy extracorporeal shockwave
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.
Arm group label:
low-energy extracorporeal shockwave
Arm group label:
low-energy extracorporeal shockwave and a tailored exercise program
Other name:
ESWT
Intervention type:
Other
Intervention name:
tailored exercise program
Description:
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch,
Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
Arm group label:
low-energy extracorporeal shockwave and a tailored exercise program
Arm group label:
tailored exercise program
Other name:
TEP
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.
Criteria for 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
Gender:
Female
Minimum age:
40 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hany Mohamed Elgohary
Address:
City:
Cairo
Zip:
11432
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Hany M Elgohary, PhD
Phone:
0590997821
Email:
gohary75pt@hotmail.com
Facility:
Name:
Mohamed
Address:
City:
Cairo
Zip:
P.O.Box 11432
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Amr A Abouzeid, PH.D
Phone:
00201006134539
Email:
amrahmedabouzid@mans.edu.eg
Start date:
April 15, 2023
Completion date:
September 1, 2023
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05920369
