Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome

Cairo University (CU)

Status: Enrolling

Conditions: Axillary Web Syndrome

Treatments: Other: low-energy extracorporeal shockwave and a tailored exercise program; Other: tailored exercise program; Other: low-energy extracorporeal shockwave

Study type: Interventional

Funder types: Other

Identifiers

NCT05920369

F.P.T2207006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

93 participants in 3 patient groups

low-energy extracorporeal shockwave and a tailored exercise program

Experimental group

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

Treatment:

Other: low-energy extracorporeal shockwave

Other: tailored exercise program

Other: low-energy extracorporeal shockwave and a tailored exercise program

low-energy extracorporeal shockwave

Active Comparator group

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.

Treatment:

Other: low-energy extracorporeal shockwave

tailored exercise program

Active Comparator group

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.

Treatment:

Other: tailored exercise program