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

Not Applicable

Recruiting

• Conditions: Axillary Web Syndrome

• Registration Number: NCT05920369
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-04-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
digital inclinometer	4 weeks	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

Name	Time	Method
visual analogue scale	4 weeks	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	4 weeks	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	4 weeks	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

Trial Locations

Locations (2)

Hany Mohamed Elgohary; 🇪🇬 Cairo, Egypt

Mohamed; 🇪🇬 Cairo, Egypt